In January, Moderna said it had COVID-19 vaccine orders worth $11.7 this year. Now, that number has expanded to $18.4 billion. Meanwhile, amid supply woes in Europe, AstraZeneca says it will “make use of its global capability” to deliver 180 million vaccine doses to the EU by the end of the second quarter of this year.
A movie-length, Pfizer-sponsored film from National Geographic follows how the drug giant and its partner BioNTech quickly developed their coronavirus vaccine and brought it to market.
Next month, when SK Bioscience of South Korea launches an IPO, it expects to raise $900 million and clear the way for major expansion which would create more opportunities to produce and develop coronavirus vaccines.
Finally, Altimmune is taking its single-dose, needle-free COVID-19 vaccine, which is administered through the nose, into phase 1 testing.
The worldwide case count was at more than 112 million by Thursday afternoon, with more than 2.5 million reported deaths, according to Johns Hopkins University's COVID-19 dashboard.
Please read below for the latest updates. Daily COVID-19 tracker entries from Aug. 11 to Oct. 30 can be found here. Entries from April 21 through Aug. 11 are here. Entries from Jan. 30 through April 20 are here.
UPDATED: Thursday, Feb. 25 at 4:15 p.m. ET
Moderna has already secured $18.4 billion in advance purchase agreements for COVID-19 vaccines this year, the company reported. The figure is a substantial increase on what the company reported last month ($11.7 billion) for its 2021 advance purchase agreements. Moderna’s effort to rapidly produce and deliver vaccines has been a game-changer for the Cambridge, Mass. company. In all of 2019 Moderna generated $60 million in revenue. In the final quarter of 2020 alone, it racked up $571 million. Story
AstraZeneca will “make use of its global capacity,” said a company spokesman, to supply Europe with 180 million doses of promised coronavirus vaccine. The British-Swedish drug company has received sharp criticism from the EU for failing to meet delivery milestones and issuing warnings that more manufacturing problems could lead to shortfalls in the second quarter. AZ plans to fulfill its pact with the EU with equal parts contributions from its European and overseas supply lines. Story
“Mission Possible” is a movie-length product placement that chronicles how Pfizer and BioNTech developed their COVID-19 vaccine and brought it to the market. National Geographic's branded content group was granted near-unfettered access to produce the film, which premieres on its network on March 11, the one-year anniversary of the World Health Organization’s declaration of the pandemic. Story
South Korea drugmaker SK Bioscience will launch an initial public offering next month, expecting to raise $900 million, much of which has been earmarked for factory expansion and vaccine R&D. The move comes shortly after SK Bioscience agreed to produce 40 million COVID-19 vaccines for Novavax. Story
Altimmune has developed a single-dose, needle-free, intranasal COVID-19 vaccine soon to enter phase 1 testing, the company said in a release. The Maryland-based drugmaker touts AdCOVID as a treatment that targets the virus at its point of entry. It is designed to stimulate a broader immune response, both systemically and locally. Mucosal immunity in the nasal cavity is believed to be crucial in blocking transmission of the virus.
UPDATED: Thursday, Feb. 25 at 11:25 a.m. ET
A study of the Pfizer-BioNTech coronavirus vaccine in Israel shows the shot is highly effective, cutting cases by 94% across all age groups. Conducted by the Clait Research Institute, this was the first real-world study of this scale, differentiating it from the controlled conditions found in clinical trials. Clait compared results for 600,000 participants who had received the shot with 600,000 people who had not. The result was nearly identical to the two-dose efficacy rate (95%) registered in trials last year. Story
The U.S. will undertake a review of supply chains after President Joe Biden issued an executive order designed to bolster domestic production of critical goods including pharmaceuticals. The move is designed to build self-reliance and resilience for an economy that has been stressed by the coronavirus pandemic. Few details emerged on how it will impact the pharmaceutical industry but it could be a step toward “onshoring” drug manufacturing, an initiative that was stoked by pandemic-related lockdowns and geopolitical tension, which created supply-chain uncertainty.
The U.S. should approve the AstraZeneca vaccine as soon as possible, said Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital. Speaking on CNBC, Hotez said that due to the threat of overseas variants, Americans should not get complacent about the nation’s 57% drop in cases. “We’re all high-fiving ourselves because the numbers are going down,” Hotez said. “I’m saying we are in the eye of the hurricane and the next big wave is coming.”
An online scam selling fake COVID-19 vaccines has landed three men from the Baltimore area in jail. The website announced in capital letters, “You may be able to buy a Covid-19 vaccine ahead of time,” and offered shots priced at $30 each from Moderna. This is just one of many schemes that have emerged since the start of the pandemic. The Department of Homeland Security has seized roughly $33 million in proceeds and analyzed nearly 80,000 COVID-19 dominion names, according to an agency spokeswoman.
With the addition of a COVID-19 antibody treatment from South Korea drugmaker Celltrion, Europe’s regulator now has three such antibody therapies under review. Earlier this month, the European Medicines Agency began evaluating antibody drugs from Eli Lilly and Regeneron. After Celltrion’s antibody drug was shown to cut recovery time, South Korea conditionally approved it in November.
Actresses Angela Bassett and Rosie Perez, rapper Daveed Diggs and CNN medical expert Sanjay Gupta will appear in radio, TV and social media advertisements urging people to get coronavirus vaccines. The campaign is designed to combat hesitancy about the safety of vaccines, with an emphasis on reaching Black and Hispanic Americans, who have been more impacted by the virus.
UPDATED: Wednesday, Feb. 24 at 2:07 p.m. ET
Johnson & Johnson's vaccine is safe and effective, FDA staffers said in briefing documents released ahead of Friday's advisory committee meeting. The documents confirmed that J&J's single-dose shot was 66.1% effective at preventing infection at least 28 days after vaccination, with “no specific safety concerns identified that would preclude issuance" of an emergency authorization. Besides preventing infection altogether, the shot was 85% effective at staving off severe disease and helped keep patients out of the hospital. Story
The World Health Organization's equitable vaccine distribution scheme Covax kicked off its global rollout with the delivery of 600,000 AstraZeneca doses to Ghana. AZ's manufacturing partner Serum Institute of India is tackling production for the effort, which is co-led by Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI). Covax deliveries to Abidjan and Cote d’Ivoire are also expected this week. The facility hopes to deliver at least 2 billion COVID-19 vaccine doses by year-end.
Germany has administered a slim 15% of the AstraZeneca vaccines it has on tap, the country's health ministry said. The shot has faced skepticism from the German public after trial results placed the vaccine's efficacy below competitors'. Meanwhile, Chancellor Angela Merkel's spokesman has said that shot is safe and effective, calling for the public to put its faith in the shot.
Contract research organization PPD, heavily involved in trials for COVID-19 vaccines—including Moderna's authorized mRNA shot—saw income jump to $1.36 billion in the fourth quarter, marking a 30.3% increase over the $1.04 billion it pulled during the same period in 2019. Clinical development services, up up 28.3% on the year-ago period, and laboratory services, up 40.1%, helped drive that growth. Overall, PPD raked in $4.68 billion for the year, up 16.1% from 2019, despite withdrawing its guidance in 2020's first quarter as COVID-19 hamstrung the CRO industry. Story
The Philippines is offering to send more healthcare workers to Germany and the U.K. in exchange for vaccine doses, but the U.K. has declined and Germany has yet to respond, Reuters reports. The Philippines limits the number of healthcare workers deployed overseas to 5,000 a year, but it would be willing to lift the cap to trade for COVID shots, Alice Visperas, director of the Filipino labor ministry's international affairs bureau, said. The U.K. says it isn't interested, but reiterated its pledge to donate surplus vaccines to other countries in the future.
UPDATED: Wednesday, Feb. 24 at 11:02 a.m. ET
The European Union could face supply shortages of AstraZeneca's COVID-19 vaccine extending into the second quarter of this year.The company warned EU officials of continuing problems at a factory in Belgium that is producing the shot. But EU president Ursula von der Leyen said she's optimistic that supply shortfalls can be remedied. AZ remains hopeful that it can compensate for any shortfall by the third quarter. Overall, AZ’s total supply to the EU by late June could reach 130 million doses, far short of the promised 300 million. Story
The FDA will approve Pfizer and BioNTech’s request to store their COVID-19 vaccine at standard pharmacy temperatures instead of ultra-cold freezers, according to the New York Times. The move modifies guidance, issued when emergency authorization was granted for the shot in December, which required it to be stored at temperatures between -80 and -60 degrees Celcius.
The NIH will study how pregnant COVID-19 patients metabolize and tolerate remdesivir. The Gilead Sciences antiviral drug, approved last summer for coronavirus patients with pneumonia who required oxygen, has since gained wider use. The study will take place in 17 U.S. cities and will compare remdesivir use in pregnant and non-pregnant patients of reproductive age who are hospitalized with COVID-19.
The case history of a deceased U.K. COVID-19 patient who had received chemotherapy for lymphoma has given experts a better idea of how coronavirus variants may arise in people with compromised immune systems. The study reveals how selective pressures bring about viral mutations, according to Ravindra Gupta of Cambridge University’s medical team. The case “has been transformative of understanding what’s going on with this disease,” Gupta told Scientific American.
In response to reports of Germans refusing AstraZeneca’s COVID-19 shot because of side effects—and vials of it going to waste as a result—EU president Ursula von der Leyen said she would take the vaccine “without a second thought, just like Moderna’s and BioNTech/Pfizer’s products.” Her remarks, to the Augsburger Allgemeine, come amid growing frustration over the lagging pace of AZ’s vaccine supply to the EU and suggestions, denied by the company, that the British-Swedish company has given supply preference to the U.K., where more than a quarter of the population has been vaccinated.
The HHS will no longer allocate doses of COVID-19 antibody drugs from Eli Lilly and Regeneron because scarcity is no longer an issue. The drugs will remain free, according to a release from the American Hospital Association, and can now be ordered directly from AmerisourceBergen, the sole distributor of antibody drugs.
China’s fourth domestically-developed COVID-19 vaccine may soon be available. Sinopharm and CanSinoBIO have registered their vaccine for authorization. The treatment was previously approved for emergency use last July for those with a higher infection risk. It is the second Sinopharm vaccine. The first was approved in December. China has yet to approve any overseas vaccines for domestic use.
UPDATED: Tuesday, Feb. 23 at 4:32 p.m. ET
Pfizer is eyeing price hikes for its COVID-19 vaccine after the pandemic, according to a top company executive. On an earnings call this month, CFO Frank D’Amelio said Pfizer is “going to get more on price” after what he termed the “pandemic pricing environment.” Pfizer, which was first to the market in the COVID-19 vaccine race, is charging the U.S. $19.50 per dose. By comparison, Pfizer’s pneumococcal vaccine Prevnar 13 fetches more than $200 per dose on the private market. Story
According to a study by Merck KGaA, the coronavirus pandemic has put increased stress on unpaid caregivers. Surveying 9,000 people in 12 countries, Merck found that caregivers are facing added physical, mental and financial burdens. The pandemic has forced 20% of caregivers into first-time roles. Caregivers are spending 23 hours per week on average tending to their loved ones, an increase of more than seven hours from before the pandemic. In addition, 22% say they’ve had to reduce their paid hours due to caregiving responsibilities. Story
The FDA told vaccine makers on Monday that large clinical trials to assess the effectiveness of authorized shots against coronavirus variants are not necessary. New guidance from the FDA suggests smaller trials “that compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine” are sufficient to determine the effectiveness of the modified vaccine.
The coronavirus pandemic may force Novartis India to lay off roughly 170 people. The proposed cuts would be to the pharmaceutical segment of Novartis, a senior executive told The Times of India. The India arm of the Swiss drug giant reported a net loss in the fourth quarter of last year after posting profits in the same quarter of 2019.
UPDATED: Tuesday, Feb. 23 at 11:12 a.m. ET
Pfizer and Moderna will tell Congress today of their plans to increase supplies of their respective COVID-19 vaccines for the United States. Thanks to manufacturing overhauls, Pfizer expects by mid-March to be delivering 13 million doses of COVID-19 vaccine per week. The increase puts Pfizer on track to provide 120 million doses by the end of March and meet its pledge of 300 million by the end of July. Moderna is on a similar trajectory, expecting to have delivered 100 million doses by the end of March on its way to 300 million by the end of July. In addition, Johnson & Johnson, whose single-shot vaccine is set for review Friday by the FDA, is prepared to deliver 20 million doses by the end of March. Story
Aridis has updated its investigational COVID-19 monoclonal antibody treatment, AR-711, to neutralize emerging variants of the virus. The new version, AR-713, will begin clinical trials in the second half of this year. AR-711 is an inhaled drug for COVID-19 patients who are not hospitalized. According to Aridis, AR-713 has been shown to neutralize the South African variant as well as the Brazilian and Japanese strain, while also negating the original COVID-19 strain and its U.K. variant.
COVID-19 patients in Europe who do not need oxygen support may later this year be treated with remdesivir, Gilead’s antiviral drug. The European Medicines Agency is evaluating data from Gilead and could issue an opinion by the summer. Europe approved the drug last July for coronavirus patients 12 and older who had pneumonia and required oxygen. Earlier this month, Gilead predicted sales of $3 billion for the drug this year.
The FDA has issued new recommendations for drugmakers to address the impact of emerging COVID-19 variants on their products. In a press conference FDA commissioner Janet Woodcock said, “We need to identify efficient ways to modify the products that are either in the pipeline or are EUA products to address these variants.” Woodcock emphasized that treatments must be monitored to ensure that if performance is altered, the FDA and manufacturers are made aware.
With supplies lacking and amid public resistance to the AstraZeneca COVID-19 vaccine, Germany is adjusting its inoculation strategy. With the reopening of schools, which have been closed since November, teachers will get priority access to the AZ shot. Next in line are police officers and members of the army. This comes after many front-line health workers refused the AZ shot amid reports of side-effects. Germany has administered 5 million vaccine doses, which accounts for 6% of its population, lagging behind the U.K. and U.S.
Clover Biopharmaceuticals has raised $230 million in a round of oversubscribed Series C financing, which brings the China-based company’s total capital raised in the last 12 months to more than $400 million. In part, the proceeds will support Clover’s continued development of its COVID-19 vaccine and production planning for potentially hundreds of millions of doses this year. Clover will initiate a global phase 2/3 efficacy trial for its vaccine in the first half of this year. Story
UPDATED: Monday, Feb. 22 at 3:35 p.m. ET
Sanofi signed a deal to manufacture Johnson & Johnson’s coronavirus vaccine. The plant in France will produce 12 million doses of the J&J vaccine per month. The deal comes after another Sanofi agreement to make 100 million doses of the Pfizer-BioNTech vaccine this year. Story
Also from Sanofi, the company has not given up on its own effort to develop a COVID-19 vaccine. Sanofi and its partner GlaxoSmithKline said they are starting a phase 2 study of their second try at a shot, which combines Sanofi’s recombinant protein-based vaccine with GSK’s adjuvant. After weak early results forced them to retool, this version offers an “improved antigen formulation," the company said. If the trial is successful, it would clear the way for phase 3 testing in the spring and production of doses before year-end. In another partnership, Sanofi and Translate Bio are working on an mRNA vaccine that's set to enter testing next month. Story
Eli Lilly CEO David Ricks was paid $23.7 million last year, an 11% increase on his 2019 compensation, according to a recent proxy filing. The figure likely places Ricks among the world’s highest-paid pharma execs for 2020. His lucrative package reflects a successful year for the Indianapolis-based pharma, which earned emergency authorization for multiple COVID-19 therapies in addition to notching first-time approvals for cancer drug Retevmo and mealtime insulin Lyumjev. In the fourth quarter last year, Lilly rang up $871 million in antibody revenue. Story
Novavax’s COVID-19 vaccine is ranked No. 2 on the Fierce Pharma list of the 10 most-anticipated drug launches of 2021. The list is ranked by predicted global sales for 2026 as compiled by Evaluate. The only drug ranking ahead of Novavax’s vaccine is aducanumab, an Alzheimer’s therapy from Biogen that is estimated to score $4.8 billion in sales in 2026. Novavax's COVID-19 vaccine sales are expected to hit $2.73 billion the same year. In January, Novavax reported 89% efficacy in a phase 3 trial in the U.K. Results in South Africa (60%) were less encouraging, but those were chalked up to the emergence of the coronavirus variant there. Novavax believes that its approach, delivering adjuvanted fragments of the spike protein made in insect cells, is well suited to the evolving virus, and analysts agree. Story
The Serum Institute of India has been instructed by government officials to meet domestic demand for its COVID-19 vaccine—produced under license from AstraZeneca—before supplying doses of the shot overseas. The announcement by Serum CEO Adar Poonawalla suggests that foreign countries are likely to face supply delays, just days after news emerged that U.K. officials were auditing the company's manufacturing ahead of potential vaccine imports. The AstraZeneca shot was approved this month by the World Health Organization, clearing the way for supplies to low- and middle-income countries. Story
UPDATED: Monday, Feb. 22 at 10:50 a.m. ET
Within the next few weeks, Pfizer will double its coronavirus vaccine supply to the U.S., said CEO Albert Bourla. Speaking Friday afternoon after President Joe Biden toured Pfizer’s factory in Portage, Michigan, Bourla said improvements at the plant had reduced the time needed to produce its shot to 60 days from 110 days. As of Feb. 17, Pfizer had supplied the U.S. with 40 million doses. Pfizer’s current supply rate is 5 million per week. The company has promised 300 million doses to the U.S. by the end of July.
FDA review documents due for release this week will give the agency's infectious disease panel feedback for their upcoming review of the Johnson & Johnson COVID-19 vaccine. The document release—and Friday's advisory committee meeting and vote—are key steps in the approval process. Late last year, vaccines from Pfizer and Moderna each gained emergency authorization one day after their respective FDA reviews. This time, though, could be more complicated because the panel will also assess the J&J vaccine's efficacy against new virus variants. The J&J shot has advantages: It doesn't have to be stored at ultra-cold temperatures, and one dose is required instead of two. But the vaccine has shown less potency against the South African variant.
In Belgium, cargo volume at Brussels Airport was up 21% percent in January due largely to its role as an export hub for the Pfizer-BioNTech COVID-19 vaccine. Since the end of November, airlines leaving Brussels have flown Pfizer vaccines to more than 40 destinations, some as far away as Tokyo, per an announcement last week by DHL and All Nippon Airways. The cargo increase at Brussels has helped the facility compensate for a sharp decline in passenger traffic, which was down 84% compared to January of last month.
Former FDA commissioner Scott Gottlieb said the U.S. may never reach herd immunity. Speaking Sunday on “Face the Nation,” Gottlieb said that the drop in infections across the country this month is an encouraging sign that will likely continue. But when asked about vaccinating children, he said, “I don’t really think we’re ever going to reach full herd immunity. This isn’t going to be like measles or smallpox, which just sort of goes away. COVID is going to continue to circulate at a low level.” As of Feb. 18, the rolling average for new infections had fallen 43% in the U.S. in two weeks.
Novavax announced it had wrapped up enrollment in Prevent-19, its phase 3 vaccine study in the U.S. and Mexico. The trial in 30,000 participants emphasizes diversity, including LatinX (20%), African American (13%), Native American (6%), Asian American (5%) and adults 65 years and older (13%) participating.
Dynavax and the Serum Institute of India announced they had dosed their first patients in a clinical trial of their partnered COVID-19 vaccine, adjuvanted with CpG 1018. The phase 1 portion will enroll 39 healthy volunteers, with 216 subjects on tap for phase 2. CpG 1018 is used in Heplisav-B, a hepatitis B vaccine which provides an increased vaccine immune response.
Vaccines use in Scotland reduced the risk of hospitalization by as much as 94% after four weeks of the first shot, a real-world study found. Experts compared people who have received a first dose against those who hadn't. Those vaccinated with the AstraZeneca jab had a reduced hospitalization risk of 94%, while those who received the Pfizer vaccine saw an 85% reduction. In the high-risk 80-plus age group, hospital admission was reduced by 81% four weeks of receiving the shot.
UPDATED: Friday, Feb. 19 at 4:15 p.m. ET
New studies show that people who have had the coronavirus should still be vaccinated. One dose of vaccine can stoke antibodies, vanquishing the virus and even some of its potent variants. The latest study, which analyzed blood samples of those who have had COVID-19, indicate that they would have trouble fending off the B.1.351 strain from South Africa. But one dose of a Pfizer or Moderna vaccine boosted antibodies by a thousandfold.
In a Harris Poll survey this month, 62% of Americans gave the pharmaceutical industry a positive rating as opposed to 32% the same time last year. The poll shows pharma's typically poor reputation has improved during the pandemic as companies worked proactively and collaboratively to develop vaccines and rush them to market. Respondents rate the industry on a scale of 1-7; In January of 2020, only 32% assigned a rating of 5, 6 or 7. This month 62% did so. Story
Other pharma companies have beaten Novavax to the punch in rolling out COVID-19 shots. But the Maryland drugmaker landed a roundhouse blow on Thursday, agreeing to supply 1.1 billion doses of its yet-to-be authorized COVID-19 vaccine. Novavax made the deal with Gavi, the Vaccine Alliance, and COVAX, which are working on equitable worldwide distribution of COVID-19 vaccines. Novavax will itself provide vaccines for high-income markets while the Serum Institute of India will supply other countries under a no-cost license. Story
The coronavirus pandemic was the dominant theme in the pharmaceutical industry in 2020. But GlobalData’s review of the top 10 companies by market cap revealed that the fortunes of many were not tied to their COVID-19 performance. While AbbVie had the largest market cap increase (44.3%) over the course of the year, despite a lack of COVID-19 products, big-time vaccine providers Pfizer and AstraZeneca failed to beat their pre-COVID market valuations. Other companies, however, such as Eli Lilly, Roche and Johnson & Johnson, parlayed their COVID successes into market cap growth. Story
Novartis CEO Vas Narasimhan saw his pay decrease from $11.61 million to $11.44 million in 2020, due largely to a pandemic-driven shortfall in sales. Narasimhan’s base salary increased by 5.5% last year, but a bigger decline in his annual bonus accounted for the overall compensation drop. Story
Pfizer provided data to the FDA showing its coronavirus vaccine can be stored at higher temperatures than previously known, which would allow pharmacies greater flexibility in managing their vaccine supplies. Now, the vaccine must be stored at temperatures between -80 and -60 degrees Celsius for up to six months—temperatures that require special, ultracold freezers. But Pfizer's new data show it can withstand storage at temperatures of -25 to -15 degrees Celsius, meaning standard pharmaceutical freezers would be suitable—provided the agency approves a label change.
The United Kingdom’s National Health Service established a social media effort designed to bolster confidence in the nation’s coronavirus vaccine push. On Friday, social media users gained access to an array of Facebook frames and Instagram GIFs that show “I’ve had my vaccine” or “I will get my vaccine.” The messages will be available in 13 languages by Feb. 22.
German health officials are emphasizing the safety of the AstraZeneca COVID-19 vaccine amid reports that thousands of essential workers are rejecting the shot because they're afraid of side-effects. Like most European countries, Germany does not offer a choice of vaccine. As a result, many are skipping appointments and several hundred vials have gone unused.
President Joe Biden will travel to Michigan on Friday to tour a Pfizer manufacturing facility that's cranking out COVID-19 vaccines. Biden is expected to discuss with Pfizer officials how employing the Defense Production Act can help the company quickly produce and distribute more vaccines. Pfizer has committed to supply 100 million doses by the end of March and a total of 300 million by the end of July.
South Korea announced it will spend $237.1 million to develop COVID-19 treatments and vaccines. The goal is to have a local vaccine developed by early next year. “Even though we will start COVID-19 vaccination soon, we have to secure our capacity to prepare (for) new infectious diseases in the long term,” said health and welfare minister Kwon Deok-cheol.
UPDATED: Thursday, Feb. 18 at 4:13 p.m. ET
Typical side effects of COVID-19 vaccines are fever, fatigue, nausea and headaches. But there is fear in some European countries that the effects are more prevalent with the AstraZeneca vaccine, the last of three to be authorized in Europe. In France, health authorities have ordered administration of the shot to be staggered to limit the potential impact on healthcare services. In Germany, some essential workers have refused the shot. In two regions in Sweden, vaccinations have been put on hold. Story
Pfizer and BioNTech's vaccine trial in pregnant women will include approximately 4,000 participants in the U.S. Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the U.K. The women must be 18 years or older and 24 to 34 weeks into their pregnancy. The first doses have already been administered in the U.S. The study will assess the safety in infants of vaccinated pregnant women and potential transfer of antibodies to infants.
Approval of the Johnson & Johnson vaccine is expected in early March, but there will be only a “few million” doses available right away, according to coronavirus response coordinator Jeffrey Zients. Johnson & Johnson’s contract with the government calls for 100 million doses to be delivered by the end of June. White House chief medical advisor Anthony Fauci expressed his disappointment at the low numbers, but also said that he expects a significant increase from J&J in the spring. Story
The Belgian plant blamed for AstraZeneca's vaccine delivery shortfalls in Europe has undergone recent changes. Last month, Thermo Fisher acquired it as part of a $878.2-million buyout of Novasep’s viral vector manufacturing business, just a few months after Novasep identified the site for production of the adenovirus vector for AstraZeneca’s vaccine. Now, production capacity at the plant has "drastically" increased, EU industry commissioner Thierry Breton said. Story
UPDATED: Thursday, Feb. 18 at 11:26 a.m. ET
After two Canadian researchers recommended officials delay the second dose of Pfizer's vaccine, Pfizer responded, saying it has not evaluated alternative dosing regimens and that it's up to health authorities to decide. Some countries, facing supply shortages, are considering dosing patterns that vary from how the vaccines were tested in trials. In their letter to the New England Journal of Medicine, the researchers also cited the first-dose efficacy of Moderna’s vaccine (92.1%). They added that while there is uncertainty about the duration of protection with a single dose, a second dose a month later provides “little added benefit in the short term.”
In another Pfizer study, which was published in the New England Journal of Medicine, scientists developed an engineered virus that contained the same mutations carried on the spike portion of the COVID-19 variant found in South Africa. Researchers tested the engineered virus against the blood from those given the vaccine and found a two-thirds reduction in neutralizing antibodies compared with its effect on the original version of the virus. Story
Johnson & Johnson has only a few million doses of its COVID-19 vaccine in its inventory, White House officials said. The company has committed to providing 100 million doses by the end of June, part of an agreement with the U.S. federal government. The pact carries an option for the U.S. to buy 200 million more doses. An FDA panel will review the J&J vaccine on Feb. 26. Story
Developing and selling coronavirus drugs and vaccines has produced a windfall for some in the drug industry, but the success isn't always reflected in their stock prices. For example, giants like Pfizer and Gilead are down roughly 20% from their pandemic highs, placing them in contrast to smaller vaccine developers like BioNTech, Moderna and Novavax, whose share prices have performed much better. The Wall Street Journal explains why.
German health officials are battling a perception that the AstraZeneca COVID-19 shot is a “second-class vaccine.” Concern has been fueled by reports of fevers and headaches from those who have been inoculated. After EU regulators gave the AZ shot a limited approval, Germany has provided the vaccine only to those under age 65.
French drugmaker Valneva's COVID vaccine likely won't score an approval until the final quarter of 2021, the company says, but many investors are still betting on the company. Why the optimism? Valneva is the only drugmaker in Europe or the U.S. working on an inactivated shot which stimulates an immune response by injecting a coronavirus sample that has been killed, a route used in the development of many other vaccines. As a result, Valneva’s shot has simpler storage requirements.
Billionaire Bill Gates said that vaccines developed by Novavax and Johnson & Johnson, which have yet to be approved in the U.S., will still be essential in the coronavirus fight, despite their weaker performance against a new variant of the virus identified in South Africa. Gates, whose foundation has donated millions of dollars to coronavirus research and treatment, told CNBC that “there is reduced efficacy, although Novavax and Johnson & Johnson still retain a lot of capability against those variants.”
Avigan, an antiviral drug from Fujifilm, has little benefit for COVID-19 patients once their symptoms become serious. Nine clinical trials revealed that the drug, known generically as favipiravir, helped patients in the early stages of their hospitalization but didn’t reduce mortality among those with mild to moderate cases.
The RECOVERY Trial, the world’s largest clinical trial for coronavirus treatments, has expanded internationally with the addition of Indonesia and Nepal. The trial, which was launched in the U.K., has enrolled more than 36,000 patients and produced results that have already altered clinical care, reducing the risk of those hospitalized.
UPDATED: Wednesday, Feb. 17 at 4:31 p.m. ET
Alongside Pfizer, which has pledged 200 million more vaccine doses to the EU, Moderna will provide an additional 150 million doses to be delivered in the third and fourth quarters of this year. This brings Moderna’s supply commitment to the EU up to 310 million doses by the end of 2021. Story
Inconsistent manufacturing of AstraZeneca’s COVID-19 vaccine for clinical trials against the South African variant may account for the trial's results, according to a note from SVB Leerink analysts on Wednesday. The analysts wondered if the FDA would raise concerns over manufacturing during the vaccine's U.S. review. Story
A factory in Mexico will not be able to produce AstraZeneca’s COVID-19 vaccine until early April, the country’s foreign minister said. Shipments of the active ingredient used to make the vaccine have already arrived, but a complex certification process has held up production. Mexico has already begun receiving the first of 2 million doses of the AstraZeneca vaccine from India.
In a trial of Roche's Actemra, most patients were also on the steroid dexamethasone, which has itself shown a mortality benefit in COVID-19. With the combination of Actemra and dexamethasone, the risk of progressing to a ventilator was reduced.
The Gaza Strip will receive 1,000 doses of Russia's Sputnik V vaccine after Israel approved the transfer. These are the first vaccines to reach Gaza, which has a population of two million. The Palestinian territory has reported 53,000 coronavirus cases, including 538 deaths.
UPDATED: Wednesday, Feb. 17 at 11:48 a.m. ET
FDA authorization of the Johnson & Johnson vaccine would be a critical step in the United States' battle against the pandemic, and it could be a step nearer as a key FDA panel is set to meet next week. Ahead of the meeting, FDA scientists are reviewing data from clinical trials and plan to present their findings to the committee. The review process for this vaccine has taken longer than those for Moderna and Pfizer, largely due to the complexity introduced by the COVID-19 variants.
Pfizer’s new 200 million-dose agreement with the EU will be delivered in 2021, with 75 million promised in the second quarter. The agreement is in addition to the 300 million doses Pfizer pledged to provide to the EU last year, all to be supplied in 2021. With the agreements, Pfizer expects to “deliver enough doses to vaccinate at least 250 million Europeans before the end of the year,” Pfizer CEO Albert Bourla said.
Moderna also inked a new supply deal with Europe, pledging an additional 150 million vaccine doses. In total, Europe has purchased 310 million doses of the company's vaccine for delivery in 2021.
So far, the EU has been hindered in the fight against COVID-19 as it has experienced vaccine delivery delays from key vaccine players. By the middle of last week, Pfizer had delivered 23 million doses, 10 million short of what had been promised.
The South Africa variant of COVID-19 has appeared in 32 countries so far, many of which have yet to approve the Johnson & Johnson vaccine. South Africa was set to begin vaccinating healthcare workers this week with doses from AstraZeneca, but officials put the plan on hold after reviewing evidence that the AZ vaccine has limited effectiveness against the 501Y.V2 variant.
In Taiwan, health minister Chen Shih-chung said that his country and Pfizer-BioNTech were set to make a deal in December when the drugmaker backed out. He claimed that BioNTech’s partner in China, Shanghai Pharmaceutical, had opposed the deal. Taiwan has managed the pandemic effectively, reporting only 938 cases and nine deaths.
The South Korean National Intelligence Service is disputing a claim by South Korean lawmaker Ha Tae-keung, who told CNN that North Korea had hacked Pfizer in an attempt to steal information on COVID-19 vaccines and treatments. The NIS said it “reported general incidences of hacking attempts,” but did not specify company names, including Pfizer. Ha responded that in an NIS briefing to lawmakers, Pfizer was named.
On Thursday, President Joe Biden will visit Pfizer’s manufacturing facility in Portage, Michigan, where millions of doses of the COVID-19 vaccine have been produced.
UPDATED: Tuesday, Feb. 16 at 3:30 p.m. ET
Britain is working with the Serum Institute of India to audit manufacturing processes, which could clear the way for it to supply the U.K. and EU with AstraZeneca’s COVID-19 vaccine. Serum Institute currently manufactures the vaccine for many of the world’s poorer countries while the U.K. and EU mainly receive supplies from British and European facilities. The news comes after AZ last week said it could ease European supply shortfalls by sourcing doses from non-European facilities. Story
AstraZeneca’s success in developing vaccines and drugs to battle COVID-19 has reaped dividends for company CEO Pascal Soriot, who has earned $21.52 million in 2020, according to the company’s annual report. AZ’s board cited Soriot for delivering on financial and scientific goals—and his “inspiring leadership”—amid the pandemic Story
Thomas Triomphe, EVP of Sanofi Pasteur, told Bloomberg the company was set to start early trials in the coming weeks and could roll out its mRNA-based vaccine before the end of 2021.
Amgen’s Corlanor, on the market for six years to treat heart failure, may find a new market as a treatment for COVID-19 “long-haulers,” according to researchers at the University of California, San Diego. In a trial of 22 patients with postural orthostatic tachycardia syndrome, who have similar symptoms to many recovering from COVID-19, those treated saw their standing heart rate drop from between 100-115 beats per minute to 77, compared with those taking placebo. Story
Fast-rising biotech Adagio Therapeutics has dosed its first subject in a phase 1 clinical trial of its monoclonal antibody candidate for COVID-19, ADG20. Once the safety of the drug has been determined, Adagio will assess whether ADG20 can treat and prevent COVID-19. Adagio has evidence that its candidate is effective against emerging variants, despite earlier reports of their resistance to antibody treatments. Story
Emerging variants of COVID-19 are hindering clinical trials, according to GlobalData. “Increased restrictive measures” have interfered with work to resume trials halted because of the pandemic. Those measures include strict lockdown requirements and social distancing procedures. Story
South Korea said it has found evidence of attempts by North Korea to steal coronavirus data from U.S. drugmaker Pfizer. Vaccine and treatment technology were the targets of cyberattacks by North Korea, South Korean intelligence officials said. South Korea and Pfizer are trying to determine whether the hacks were successful.
UPDATED: Tuesday, Feb. 16 at 12:12 p.m. ET
After halting its vaccine rollout, South Africa may sell its stockpile of AstraZeneca doses, said the county’s health minister.
AstraZeneca’s vaccine is the second to be approved by Australia. The country signed off on the Pfizer vaccine last month and received its first shipment of doses on Monday. Health minister Greg Hunt said he expects 1 million doses to be available each week by the end of March.
Japan will begin vaccinations next week as it prepares to host the 2021 Olympic Games, July 24-Aug. 7. The government hopes to have its entire population (126 million) vaccinated by the middle of the year.
Korea has contracted COVID-19 vaccine doses from Novovax and Pfizer that would inoculate 23 million. Combined with previous deals with the same two companies, Korea will be able to immunize 79 million. Korea will kick off vaccinations on Feb. 26, starting with those working and hospitalized in nursing homes.
The Pfizer vaccine has been highly effective in Israel, according to Clait, a health maintenance organization which covers more than half of the county. Among 600,000 who have been vaccinated, there has been a 94 percent drop in infections. The vaccinations have proven most effective for those a week after receiving their second shot.
Iceland’s success in its fight against the COVID-19 pandemic has cost the country a chance to serve as a case study by Pfizer on the ability of vaccines to create herd immunity. In hopes of inoculating 70 percent of its population by the end of March, Iceland wanted to secure 500,000 doses from Pfizer. But despite inoculating only 4 percent of the population, cases in Iceland have dropped, limiting the potential effectiveness of the study.
Speaking on “Face the Nation” on Sunday, Scott Gottlieb, the former commissioner of the Food and Drug Administration, urged the Biden administration to take “bespoke” efforts to vaccinate Americans in underserved communities. Gottlieb said that the emergence of new coronavirus variants, first identified overseas and now evident in five states, makes it imperative for Americans to be vaccinated as soon as possible, requiring more creative efforts from the government.
UPDATED: Friday, Feb. 12 at 2:50 p.m. ET
BD scored U.S. and European nods for a new COVID-19 test that also screens for influenza A and B—plus, it should detect coronavirus variants first discovered in South Africa and the U.K., BD said. Running on the company's BD MAX platform, the molecular lab test is designed to deliver results in two to three hours and process hundreds of samples per day. Concerning mutations, BD ran computer analyses showing 99.9% of the genetic sequences of the South African and U.K. variants would still match up to the molecular targets used in its tests. Story
Mallinckrodt will have to wait for an FDA decision on its regenerative skin therapy treatment StrataGraft, thanks to COVID-19 travel restrictions that forced the delay of a manufacturing plant inspection, the company said Friday. The FDA was originally due to make a decision on StrataGraft, developed to treat deep second-degree burns, on February 2. Pandemic-delayed inspections led the FDA to push back decisions on a slew of drugs last year, with Bristol Myers Squibb's CAR-T therapy liso-cel a prominent example. Story
North Carolina's state health department on Thursday reported its first case of an emerging virus variant originally discovered in South Africa. The sample of the so-called B.1.351 variant came from an adult who hadn't recently traveled and was detected by Labcorp during routine genomic sequencing. The variant has also cropped up in Maryland, South Carolina and Virginia. As of Thursday, the CDC had reported 13 B.1.351 cases in the states.
By April, it should be "open season" for vaccinations in the U.S., NIAID director Anthony Fauci told NBC. "Namely, virtually everybody and anybody in any category can start to get vaccinated," he continued. Fauci said he was hopeful that the majority of Americans would be vaccinated by the end of summer.
“By the time we get to April, that will be what I would call open season,” Dr. Anthony Fauci says about the timeline for vaccination availability for all groups to begin getting shots. pic.twitter.com/BMGD3YSVex— TODAY (@TODAYshow) February 11, 2021
Hungary is now administering the Gamaleya Institute's Sputnik V vaccine, an official at Honved Hospital in Budapest told The New York Times. In bypassing the European Medicines Agency, Hungary has become the first European Union member state to use Russia's shot. The country has some 2,800 doses left over from a 6,000-dose shipment delivered in December for testing, and it has said it expects to receive 2 million doses from Russia over the next three months. The decision has drawn fire from local health experts, who've urged Hungarian regulators to wait on EU approval.
India aims to vaccinate 300 million people by August—but over a four-week stretch, it was only able to get 7.5 million COVID vaccines into frontline workers' arms, Reuters reports. At that rate, it would take the country years to hit its immunization target. Supply isn't the issue, one local health expert said, but to meet the government's timeline, India will need to start vaccinating between four and five times more people each day. The government itself plans to pick up the pace next month, with the goal to enlist more private hospitals once priority groups get the shot.
UPDATED: Friday, Feb. 12 at 9:40 a.m. ET
The U.S. locked up a previously announced deal to buy another 100 million vaccine doses from both Pfizer and Moderna, lifting the country's total order from those drugmakers to 600 million doses. The companies will roll out shipments in regular intervals through the end of July, the Department of Health and Human Services said. The government is shelling out some $2 billion to Pfizer for the extra doses, while Moderna will receive roughly $1.65 billion. So far, the government has pledged $6 billion to Pfizer for shot supplies, while Moderna is due a total of $5.75 billion in sale proceeds and R&D investment.
Moderna says it has so far delivered 41 million vaccines to the U.S., and more than 22 million Americans have received at least one dose of its shot. The company said it's confident it can supply a total of 100 million doses by the end of the first quarter and 100 million more in Q2. It's working with manufacturing partners stateside to speed up deliveries and ship this latest order before the end of July.
The European Medicines Agency kicked off a rolling review of CureVac's mRNA vaccine. The regulator will assess data on CureVac's shot as it comes in, building the case for a potential marketing authorization. The company's shot, CVnCoV, is currently plowing ahead in a phase 2b/3 trial in healthy adults in Europe and Latin America, CureVac said.
The U.S. government's promised vaccine safety monitoring system, dubbed BEST, is still in the development stages and won't be able to analyze safety data for weeks or months, various health officials told The New York Times. FDA officials told the Times that they hope to start analyzing vaccine safety data soon, though that likely won't occur until after President Joe Biden has hit his goal of vaccinating 100 million Americans. Tracking vaccine safety is especially important given the record development time for Pfizer and Moderna's shots.
A government health panel in Japan OK'd Pfizer and BioNTech's vaccine Friday, with the country's health minister expected to issue a formal approval Sunday, Reuters reports, citing Japanese broadcaster NHK. Around 400,000 Pfizer doses arrived from Brussels on Friday as Japan gears up to start vaccinating healthcare workers by the middle of next week.
The U.K.'s National Health Service will roll out Roche's rheumatoid arthritis med Actemra, also known as tocilizumab, to "thousands more" COVID-19 patients after a positive data readout from the RECOVERY trial. In the study, Actemra cut the absolute risk of death by 4% versus standard care. In combination with the steroid dexamethasone, the drug reduced relative death risk by 14% and cut hospitalization time for patients on oxygen support by five days.
Patients given blood thinners within 24 hours of being hospitalized with COVID-19 are roughly 30% less likely to die than those who don't receive them, an observational study in The BMJ showed. Researchers followed more than 4,000 patients over 30 days; 84% of them had received an anticoagulant within one day of hospitalization. At the end of the study, 14.3% of those on blood thinners died, compared with 18.7% of patients in the non-anticoagulant group, marking an absolute risk decrease of 4.4%, or a relative risk reduction of 27%.
Pfizer and Moderna are testing their vaccines in children ages 12 and up and expect to have results by the summer. Based on those studies, the companies could then move to test their shots in even younger children, The New York Times reports. "Moving below 12 years of age will require a new study and potentially a modified formulation or dosing schedule,” a Pfizer spokeswoman told the newspaper. Moderna started testing its shot in kids ages 12 to 17 in December and aims to recruit 3,000 subjects for its study.
After German newspaper Handelsblatt last month reported AstraZeneca's vaccine was just 8% effective in people older than 65, experts and AZ itself quickly contested the figure. But the paper stood firm, citing an unnamed health ministry official, The BMJ reports. "Confusion is out of the question," a follow-up Handelsblatt story states. "According to the data available to us so far, effectiveness in people over 60 is less than 10%.” The paper “turned the matter into a ‘he says, she says’ story" to absolve itself, Markus Lehmkuhl, a professor at the Karlsruhe Institute of Technology, told BMJ.
UPDATED: Thursday, Feb. 11 at 3:07 p.m. ET
Novavax's vaccine program has already started rolling reviews in Europe, the U.S. and elsewhere, and now the company is close to a supply deal with Europe, Reuters reports. Preliminary talks completed in December and officials "aim to agree the contract this week or next," one source told the news service. The deal would be for an initial 100 million doses with an option for 100 million more.
Visby Medical scored an FDA emergency nod for its rapid, single-use PCR test designed to detect COVID-19 infections at the point of care. A palm-sized device that plugs into a power outlet can conduct the test, which takes about 30 minutes. Story
With COVID-19 vaccines already authorized, it's becoming tougher for vaccine developers to enroll trial participants in placebo-controlled studies. Second-wave vaccine companies are responding by looking at studies that weigh immune responses, rather than protection versus placebo, the Wall Street Journal reports.
While vaccine supplies are limited now, former FDA commissioners Scott Gottlieb and Mark McClellan predict a scenario not too far away when supply will exceed demand. They penned a Wall Street Journal op-ed about how to boost demand so that doses don't go unused.
UPDATED: Thursday, Feb. 11 at 11:40 a.m. ET
Roche's rheumatoid arthritis drug Actemra, also known as tocilizumab, cut the risk of death by 4% over standard care—including dexamethasone—in patients hospitalized with severe COVID-19, new data from the University of Oxford's RECOVERY trial show. The drug also helped patients leave the hospital faster and reduced the need for mechanical ventilation. In patients with severe inflammation, Actemra plus the steroid dexamethasone cut mortality by about 33% for patients needing simple oxygen and nearly 50% for those on invasive mechanical ventilation, the researchers said.
AstraZeneca's asthma med Pulmicort, or inhaled budesonide, cut the risk of urgent care or hospitalization by 90% over a 28-day stretch, a study run by the University of Oxford and posted on the pre-print server MedRxiv showed. Researchers looked at 148 patients, half of whom received 800 micrograms of Pulmicort twice a day. Alongside reduced risk of hospitalization, the drug also led to “quicker resolution of fever, symptoms, and fewer persistent symptoms” after 28 days.
Speciality chemicals company Evonik is investing in the short-term expansion of its speciality lipids production to help boost supplies of Pfizer and BioNTech's mRNA vaccine. Commercial lipid production is set to kick off at the company's Hanau and Dossenheim, Germany, sites as early as the second half of 2021, Evonik said.
Merck & Co. is "actively involved" in talks with governments, health agencies and other drugmakers to chip in on the pandemic response, including manufacturing authorized COVID-19 vaccines, a spokesperson told Fierce Pharma. Merck hasn't said which companies it could support, but there've been rumblings it may tie up with Novavax. Evercore ISI analyst Josh Schimmer said as much after Novavax presented phase 3 data last month, while Novavax CEO Stan Erck told CNBC that Merck "could be a good partner for us as they don't have a competing product." Story
Novartis Oncology's new campaign “Let’s Talk about the C Word: From Cancer to Cures," aims to remind people that cancer hasn't vanished amid the COVID-19 pandemic. “Especially during the pandemic, cancer got completely forgotten, and what for me was very concerning is that screenings were disrupted and diagnostics are now very late," Susanne Schaffert, Ph.D., president of the company's oncology unit, told Fierce Pharma. The monthly series of six short videos launched on World Cancer Day and focuses on prevention, diagnosis and disease management. Story
UPDATED: Wednesday, Feb. 10 at 3:11 p.m. ET
AstraZeneca's shot can be used to vaccinate all adults ages 18 and up, a World Health Organization panel recommended Wednesday. Efficacy isn't expected to differ between young and old recipients, Alejandro Cravioto, chairman of the WHO’s Strategic Advisory Group of Experts on Immunization, said. The recommendation comes as some European countries like Norway and Portugal have sought to limit the shot's use in people over the age of 65.
AstraZeneca and its German manufacturing partner IDT Biologika aim to hasten output of finished vaccines in Europe by the second quarter. Looking ahead, both companies plan to invest in a capacity upgrade at IDT Biologika's site in Dessau, Germany, building up to five 2,000-liter bioreactors that can churn out "tens of millions" of COVID shot doses per month. The new bioreactors are expected to come online by the end of 2022. The move could support production of shots with similar manufacturing processes, paving the way for "Europe’s future vaccine supply independence," AZ said.
Several people who received Pfizer or Moderna's vaccine soon after developed the rare blood disorder immune thrombocytopenia, though it's unclear whether the shots themselves were responsible, The New York Times reports. FDA and CDC officials are investigating and say the cases could be coincidental. Pfizer told The Times it so far hadn't established a link to its vaccine, while Moderna told the news outlet it “continuously monitors the safety" of its shot. Hematologists said the shot may have played a part, but noted cases after vaccination were likely to be very rare.
South Korea approved AstraZeneca's vaccine for emergency use in all adults ages 18 and older, with the caveat that AZ still needs to provide late-stage clinical data, The Korea Herald reports. While the country OK'd the shot in older adults, its Ministry of Food and Drug Safety recommends doctors use caution before deciding to give the vaccine to people over the age of 65. Korea is in line to receive 1.5 million AZ doses on February 24.
Thailand's drug regulator is expected to sign off on Sinovac's shot around the same time the country receives its first 200,000-dose shipment later this month, Bloomberg reports. It will use the Chinese-made vaccine to launch its immunization effort, though the majority of Thailand's vaccines will come from AstraZeneca via local drugmaker Siam Bioscience. Thailand was banking on a 50,000-dose delivery of AstraZeneca shots to start its vaccination program on February 14, but the drugmaker's tiff with Europe has delayed shipments to the country, Bloomberg said.
The European Union made some missteps in its handling of the pandemic, Ursula von der Leyen, president of the European Commission, told lawmakers. "We were late to authorize," she said, adding that the bloc was "too optimistic when it came to massive production, and perhaps too confident that what we ordered would actually be delivered on time"—bringing to mind the EU's public supply beef with AstraZeneca. Still, it's better that the EU moved as a bloc and didn't leave member states to fend for supplies themselves, von der Leyen said.
Texas is teaming up with the feds to build out three mass vaccination sites, Reuters reports. Each site will aim to deliver about 10,000 doses a day and should start getting shots into patients' arms by February 22, Jeffrey Zients, the White House's COVID-19 response coordinator, said. The sites will pop in the Dallas and Houston areas, with one pegged for the Dallas Cowboys' AT&T Stadium in Arlington. The Federal Emergency Management Agency (FEMA) will run the sites.
UPDATED: Wednesday, Feb. 10 at 9:30 a.m. ET
People may be getting COVID-19 vaccines every year for the next several years, Johnson & Johnson CEO Alex Gorsky told CNBC's Meg Tirrell. He pointed to the rise of virus variants, warning that every time the virus mutates, "it’s almost like another click of the dial so to speak where we can see another variant, another mutation that can have an impact on its ability to fend off antibodies or to have a different kind of response not only to a therapeutic but also to a vaccine.”
Eli Lilly's antibody cocktail of bamlanivimab and etesevimab won an FDA emergency nod to treat mild to moderate COVID patients ages 12 and up who are at high risk of advancing to severe disease or hospitalization. The therapy, delivered as a single intravenous infusion, should be given "as soon as possible" after a person tests positive and within 10 days of symptoms starting, Lilly said. The FDA also signed off on infusion times for bamlanivimab alone and in combination with etesevimab as short as 16 or 21 minutes, respectively. Story
BioNTech has kicked off mRNA production at its facility in Marburg, Germany, and estimates a single mRNA batch at current scale is good for some 8 million doses. To ship out those supplies, the production processes at Marburg must first be cleared by the European Medicines Agency, with an assessment pegged for February and March, BioNTech said. Once fully operational, the site will boast capacity for 750 million doses a year. BioNTech aims to crank out 250 million doses at Marburg in the first half of 2021 and plans to deliver the first doses from the site in April. Story
India-based drugmaker Wockhardt bagged a six-month extension of its agreement with the U.K. to fill and finish AstraZeneca's vaccine, the Daily Post reports. Wockhardt subsidiary CP Pharmaceuticals will continue to carry out the work at its plant in Wrexham, Wales, which is also getting 40 new hires.
South Africa next week will start vaccinating frontline healthcare workers with Johnson & Johnson's unapproved shot, health minister Zweli Mkhize said. The country will use the rollout to study the shot's efficacy, particularly against a virus variant that's become dominant in the country. South Africa is now bypassing AstraZeneca's shot altogether because it “does not prevent mild to moderate disease” caused by the variant, Mkhize said. “The Johnson & Johnson vaccine has been proven effective against the 501Y.V2 variant," he said, adding that South African approval processes were underway.
Japan has locked down 144 million Pfizer vaccine doses—enough for 72 million people—but thanks to shortages of low dead space syringes needed to extract a sixth dose from vials, some 24 million shots will go to waste, the Independent reports. If healthcare workers can't muster that sixth dose, the extra product will need to be tossed, government spokesman Katsunobu Kato said. “We will use all the syringes we have that can draw six doses, but it will, of course, not be enough as more shots are administered," Norihisa Tamura, Japan's health minister, said.
A Trump appointee put pressure on the FDA to green light hydroxychloroquine and convalescent plasma in COVID-19, according to nearly 100 pages of emails released by the House Select Subcommittee on the Coronavirus Crisis. Paul Alexander, who last year served as a senior advisor to then-HHS assistant secretary for public affairs Michael Caputo, reached out directly to FDA chief Stephen Hahn and former deputy commissioner for medical and scientific affairs Anand Shah to push the treatments—in at least one case after HCQ's emergency nod had been rescinded.
Drugmakers need to set aside old rivalries to keep COVID-19 vaccine supplies afloat, Carlo de Notaristefani, a former Teva exec and a lead manufacturing and supply chain adviser to Operation Warp Speed, said. If a company's vaccine program is delayed or terminated, manufacturing resources should immediately be divvied up among those still in the race, he said. To make the move more enticing for highly competitive pharma companies, the government should act as a matchmaker, providing collaboration incentives and adapting existing rules, he added.
UPDATED: Tuesday, Feb. 9 at 3:13 p.m. ET
mRNA vaccines are likely the “go-to” for a single-antigen pandemic where speed is key, but in other disease areas with established prophylactics, mRNA candidates will face competition from “standard of care” vaccines that boast a “well-characterized safety profile,” Sanofi CEO Paul Hudson told Barron’s. The COVID-19 pandemic helped put mRNA on the map, but that doesn’t mean developers should “walk away” from established tech just yet, vaccine experts agreed on a recent Fierce Pharma panel. Story
Verily is joining forces with Johnson & Johnson’s Janssen unit to identify early warning biomarkers for COVID-19 that could guide future treatments and potentially predict whether a person’s case may turn severe. Verily will use its Project Baseline testing program, collecting biological information and real-world data in the weeks right after a person tests positive, with subjects able to participate from their homes. The parties will also tap data from patients' everyday lives to ID any health-related signals in the two years before and after they consent to the study. Story
Baltimore Mayor Brandon Scott wants Johnson & Johnson to sell 300,000 vaccine doses straight to the city to help distribute supplies equally. In a letter to J&J, Scott said that if the sale goes through—pending federal approval and interest from J&J—he would set up a subcommittee of the city’s Vaccine Distribution Task Force that includes company representatives, Baltimore health department officials and community leaders. Maryland governor Larry Hogan was less optimistic: “I mean, everybody would like a jump to the front of the line, but it’s not going to happen,” he said.
As Mayor, my highest priority is keeping Baltimoreans healthy and safe.— Brandon M. Scott (@MayorBMScott) February 8, 2021
Today, I sent a proposal to @JNJGlobalHealth requesting partnership to directly purchase 300,000 vaccines manufactured here in Baltimore and ensure equitable vaccine distribution. Full letter below. pic.twitter.com/X68jR80y8F
Miami-based Veru reports that its cancer asset, VERU-111, charted a “statistically significant and clinically meaningful reduction” in the proportion of COVID patients who were treatment failures—meaning dead or alive with respiratory failure—in a 40-subject phase 2 trial. The company tested its drug in hospitalized patients at high risk of acute respiratory distress syndrome from the virus. At the 29-day mark, the VERU-111 group, which included 18 patients, had a treatment failure rate of 5.6%, versus the 20-patient placebo arm’s 30%. Story
Tiziana Life Sciences’ intranasal antibody hopeful foralumab helped patients in a small phase 2 study. The trial randomized 39 patients to receive foralumab, foralumab plus dexamethasone or no treatment. The foralumab group displayed 80% improvement in the lungs, compared to 75% in the combo cohort and 43% in the control group, CT scans showed. Antibodies usually aren’t a good fit for nasal delivery, but Tiziana pegged foralumab as an exception after assessing its ability to act on systemic immunity via the epithelial lining of the nose. Story
New oncology trials plummeted 60% globally during the first wave of the COVID-19 pandemic, which ran from January to May 2020, data out from Medidata and published by the JAMA network found. The pandemic “may be associated with longer term indirect effects on population morbidity and mortality through pathways such as halted drug development,” according to the JAMA findings. Story
UPDATED: Tuesday, Feb. 9 at 11:25 a.m. ET
Merck KGaA expanded its pact with German compatriot BioNTech to rapidly boost lipid supplies for the company's mRNA shot by the end of the year. To build out its already impressive lipid production capacity, Merck KGaA says it's spent the past several weeks tweaking production technologies and implementing new, complex process steps. Lipids are combined with mRNA to create lipid nanoparticles, central to the delivery of Pfizer and BioNTech's shot.
The viral vector vaccine developed by China's CanSino Biologics was 65.7% effective at preventing symptomatic disease in phase 3. Against severe disease, the shot was 90.98% effective, Pakistan's health adviser, Faisal Sultan, said on Twitter. CanSino later forwarded Sultan's comments in a statement. Like Johnson & Johnson's shot, CanSino's vaccine works at one dose and is easier to store than the mRNA vaccines from Pfizer and Moderna. CanSino's phase 3 included 30,000 subjects across Pakistan, Russia, Argentina, Mexico and Chile.
Johnson & Johnson is looking to manufacture its COVID-19 vaccine in India, Reuters reports, citing a local government official. The country currently feels confident about the efficacy of AstraZeneca's vaccine, which is being produced by Serum Institute of India for some countries under the name Covishield, the official added.
South Africa could still deploy AstraZeneca's vaccine in a "stepped manner," rolling out 100,000 doses and monitoring their effect on hospitalizations and deaths, the Sunday Times reports. Multiple countries and health organizations defended AZ's shot after a new study showed it was less effective against a virus variant discovered in South Africa. “Obviously the world is full of the wild type virus that this AstraZeneca vaccine is known to work against,” Richard Hatchett, CEO of CEPI, said. Other health experts cited limitations in the size and duration of the study.
India, for its part, hasn't discovered any local cases of the South African variant and will continue to use AstraZeneca's shot in its vaccination drive, Reuters reports. The country will "intensify" its surveillance and watch other developments on the shot "in due course," according to top Indian vaccine official Vinod Kumar Paul.
Israel's MyHeritage lab, which handles more than 10,000 COVID-19 tests a day, unveiled partial evidence that Pfizer and BioNTech's vaccine stops the virus' spread. The lab said positive test results among patients ages 60 and older had up to 60% smaller viral loads than those from patients between the ages of 40 and 59. The shift started in mid-January, when most of the country's older population had received its first dose. The results are limited because MyHeritage didn't know if individual samples came from patients who'd received the shot.
The coronavirus likely jumped to humans from an animal, Peter Ben Embarek, food safety and animal diseases expert at the World Health Organization, said Tuesday. Embarek's remarks came after his WHO team wrapped its investigation on the coronavirus' potential origins in the city of Wuhan. The exact animal host hasn't been identified, and Embarek partially discounted the possibility of a direct jump from bats, suggesting more work needs to be done to trace potential transmission.
UPDATED: Monday, Feb. 8 at 3:10 p.m. ET
AstraZeneca and the University of Oxford will tweak their vaccine to target virus variants with mutations similar to the South African version, dubbed B.1.351. “Efforts are underway to develop a new generation of vaccines that will allow protection to be redirected to emerging variants as booster jabs, if it turns out that it is necessary to do so,” Oxford's Sarah Gilbert, Ph.D., said in a statement. The new shot could be ready by fall, she added. The move comes after a new study cast doubt on the shot's efficacy against mild and moderate disease caused by the B.1.351 variant. Story
Those study results led South Africa to halt its rollout of AstraZeneca's vaccine, prompting several other countries to defend the shot, Reuters reports. AZ's vaccine offers adequate protection against "nearly all the variants" of the virus, French Health Minister Olivier Veran said, and all three shots cleared in Europe, including AZ's, defend against serious infections, Jens Spahn, Germany's Health Minister, said. There's currently no evidence to suggest AZ's shot has become less effective at preventing severe disease and death, Gregg Hunt, Australia's Health Minister, added.
Covaxx's multitope protein/synthetic peptide-based vaccine candidate, UB-612, yielded neutralizing antibodies in 100% of patients after two doses, early phase 1 data showed. Researchers looked at three doses—10, 30 and 100 micrograms—in 60 healthy adults between the ages of 20 and 55. At the the 100-microgram dose, anti-spike-protein receptor-binding domain and virus-neutralizing antibody responses "compared favorably" to those from hospitalized patients who'd recovered from COVID. The majority of side effects were short and mild, and none were serious, Covaxx added.
Eighty percent of Americans appear willing to get a COVID-19 shot, a new W20 Group study using search and social data found. Among politically right-leaning respondents—defined as those who follow at least three right-leaning politicians, journalists or news outlets—only 41% show a willingness to get the vaccine, versus 95% of the center left, 93% of the educated left and 91% of apolitical groups ready to get the shot. Sixty percent of those right-leaning respondents unwilling to get the vaccine cited freedom of choice in the matter as their main sticking point. Story
The Trump Administration meddled with testing guidance last summer "in order to hide evidence the virus was spreading rapidly among asymptomatic people,” James Clyburn, chairman of the House of Representatives’ Select Committee on the Coronavirus Crisis, alleges in letters to White House chief of staff Ron Klain and HHS acting secretary Norris Cochran. Clyburn's claim relates to the CDC's August guidance that people who'd been exposed to the virus and weren't symptomatic didn't need to get tested. The CDC has since acknowledged the potential for asymptomatic spread on its website.
A coronavirus variant that first cropped up in the U.K., dubbed B.1.1.7, could become dominant in the U.S. by March, a new study published on the pre-print server medRxiv found. The variant is spreading fast in the states, doubling roughly every 10 days, the researchers said. The team estimates that the transmission rate of the British variant is about 30% to 40% higher than more common variants, too—and that number could rise as more data come in, one of the study's co-authors told The New York Times.
UPDATED: Monday, Feb. 8 at 9:45 a.m. ET
Novavax's protein-based vaccine prospect has started rolling reviews in Europe, the U.K., the U.S. and Canada. The company has started submitting early data on the program to regulators, and the reviews are designed to speed up the process for potential emergency authorizations. The vaccine is in phase 3 testing in the U.K. and U.S., and a separate trial of the candidate previously showed high efficacy.
Pfizer aims to cut the time to produce a COVID-19 vaccine batch from 110 days to about 60 days, Chaz Calitri, VP for operations and sterile injectables, told USA Today. DNA production—the first step in Pfizer's vaccine manufacturing process—is one process in line for a speed boost, Calitri said. Making that DNA originally took 16 days, but it will soon take just nine or 10. Meanwhile, the company is adding production lines at its plants in Michigan, Missouri and Massachusetts.
AstraZeneca and the University of Oxford's vaccine looks ineffective against mild or moderate disease caused by a virus variant first ID'd in South Africa, a non-peer-reviewed study showed. Looking at both the blood of vaccinated individuals and more than 2,000 healthy subjects, South African and Oxford University researchers found that while none of the subjects died or were hospitalized, a two-dose vaccine regimen failed to confer protection. Efficacy against severe disease, hospitalizations and deaths has yet to be determined.
With those data in hand, South Africa is halting its AstraZeneca vaccine rollout, Reuters reports. “This study confirms that the pandemic coronavirus will find ways to continue to spread in vaccinated populations, as expected,” Andrew Pollard, chief investigator of the Oxford vaccine trial, told the news outlet. “But, taken with the promising results from other studies in South Africa using a similar viral vector, vaccines may continue to ease the toll on health care systems by preventing severe disease," he said.
Portugal's health ministry recommends AstraZeneca's vaccine be used in people below the age of 65. Still, older people shouldn't delay their vaccinations if AZ's shot is the only one available, the ministry said. The country on Sunday received its first batch of 42,300 AstraZeneca doses. Portugal isn't the first country to question the shot's efficacy in older patients. Norway on Thursday said it wouldn't give the vaccine to people over the age of 65, citing a lack of older participants in AZ's trials.
Sinovac's shot CoronaVac won a conditional marketing authorization from China's drug regulator. Sinovac kicked off a rolling submission in September, filing for conditional authorization on February 3. The China National Medical Products Administration issued its green light on the basis of two month's data from phase 3 trials, Sinovac said. Final results aren't yet available, and efficacy and safety will be "further confirmed" the company added. The shot is currently approved for emergency use in Chile, Turkey, Indonesia and Brazil.
Orders for Zydus Cadila's homegrown COVID-19 vaccine have outstripped capacity, Moneycontrol reports. "In terms of our opportunity size, we have orders far more than what we can make ... I have to work on prioritization of supplies and manufacturing," Sharvil Patel, managing director of Cadila Healthcare, told analysts. The company has been building out a facility to produce 120 million doses of its plasmid DNA candidate, which entered phase 3 last month. Meanwhile, Zydus says it's hunting for manufacturing partners to ultimately hit a production target of about 200 million doses.
Hospital use of the steroid dexamethasone and Gilead Sciences' antiviral Veklury, also known as remdesivir, has doubled since the summer, according to care coordination software company CarePort Health. Across the hospitals CarePort examined, Veklury use hit 17% the week of January 5, compared with 5% the week of July 7. Meanwhile, dexamethasone usage surged to 43% in January, versus 20% in July, a CarePort spokesperson said. Providers may be relying on those treatments as a stopgap until vaccinations are more widespread, CarePort figures.
UPDATED: Friday, Feb. 5 at 3:00 p.m. ET
German mRNA specialist CureVac is teaming up with the U.K. Vaccines Taskforce to study coronavirus variants and develop vaccine candidates against selected mutations. The government will hustle along clinical trials in the U.K. to secure emergency or conditional nods for the shots as quickly as possible. The pact covers an initial supply of 50 million variant vaccines, which will be manufactured in the U.K. Should any of the vaccines pass muster with British regulators, they'll be rolled out in the U.K., as well as in its overseas and dependent territories. Story
Sales for Roche's diagnostics division grew 14% over the full year of 2020, breaching 13.8 billion CHF, or about $15.3 billion. COVID-19 tests supplied a massive chunk of that revenue haul, helping to offset losses caused by pandemic lockdowns and delayed health screenings. The company's molecular diagnostics segment carried the bulk of the growth, raking in some $4.16 billion—an increase of more than 90% over 2019 at constant exchange rates. Roche last year launched 15 COVID-19 tests, including rapid, point-of-care solutions and high-throughput, centralized lab diagnostics across all test types. Story
Regeneron's antibody cocktail snared $146 million in fourth-quarter sales, falling short of analyst expectations and coming in well below the drugmaker's own predictions. Still, the cocktail could perform better in 2021: Regeneron in January agreed to sell up to 1.25 million more doses to the U.S., building on its previous order for 300,000. If uptake improves, Regeneron could bank up to $2.625 billion on the new contract. The company still has $466 million worth of doses left to deliver from its initial deal, but it aims to roll out 750,000 doses from the second order by the end of June. Story
Gilead's antiviral Veklury, also known as remdesivir, ginned up $2.8 billion in 2020. The drug enjoyed a big boost in the fourth quarter, pulling $1.93 billion, as hospitalizations and treatments peaked on the back of a COVID-19 surge, the company said. Meanwhile, as vaccination efforts gain steam, Gilead estimates between $2 billion and $3 billion in Veklury sales for 2021. Beyond the company's COVID superstar, overall sales fell 3% to $21.5 billion as generic competition for Truvada and Atripla took its toll. Story
Drugmakers ought to share their manufacturing capacity to help boost production of COVID-19 shots, WHO director general Tedros Adhanom Ghebreyesus said Friday. “We also need a massive scale-up in manufacturing,” he added.
Over time, SARS-CoV-2—the virus behind COVID-19—deletes part of the genetic code for the spike protein on its surface, which stops some antibodies from attaching to and neutralizing the virus, researchers at the University of Pittsburgh School of Medicine found. They've published their findings in the journal Science. The team found several genetic deletions, all of which changed the spike protein's shape just enough so antibodies couldn't recognize it. The virus variant first discovered in the U.K. was among those found to have these deletions, they said. Story
The same "scalper bots" that buy Playstation 5s and designer sneakers to resell at astronomical prices are targeting COVID-19 vaccine appointments, prompting pharmacies like Walgreens and CVS to mount a defense, Reuters reports. Walgreens has set up security measures like bot prevention and detection, while CVS says its appointment site "has a layered defense that includes capabilities to detect automated cyber attacks, such as botnets."
UPDATED: Friday, Feb. 5 at 10:45 a.m. ET
It's official: Johnson & Johnson has filed for emergency FDA authorization of its one-and-done COVID-19 vaccine. The FDA has queued up an advisory committee to parse through the application on February 26. The move comes less than a week after the Big Pharma unveiled data showing its viral vector vaccine was 66% effective against moderate to severe disease. J&J plans to have doses ready to roll as soon as the FDA makes a decision, with the goal to sell 100 million shots in the U.S. by mid-year. Story
Pfizer and AstraZeneca's vaccines are "extremely safe," says the U.K.'s drug regulator. To reach that conclusion, the Medicines and Healthcare products Regulatory Agency looked at safety reports from nearly 7 million doses administered through January 24. MHRA received 22,820 reports of suspected reactions, but almost all cases were mild and largely involved reactions like arm soreness and flu-like symptoms. Those are typical responses to the vaccine, MHRA said, noting that severe allergic reactions to Pfizer's vaccine can happen, but are rare.
Pfizer pulled the emergency use application for its vaccine in India, Reuters reported. The pharma giant met with India's drug regulator Wednesday, and “[b]ased on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” the company said. It plans to re-submit an approval request once more information becomes available. India's drug regulator previously said it wouldn't approve the shot without a small local trial in Indians, Reuters has reported.
The FDA will keep reviews for variant-focused booster shots swift, acting commissioner Janet Woodcock, M.D., said Thursday. If emerging variants necessitate boosters or changes to vaccines, the regulator won't require the same large-scale trials needed to secure an emergency nod or approval, she said. The process will likely call for safety information, as well as a potential review from an external committee of experts. The FDA plans to issue a proposal on the process in the coming weeks, Woodcock said. Story
Pfizer is ahead of schedule in its quest to deliver an additional 100 million shot doses to the U.S., company representatives said Thursday before the Michigan House Health Policy Committee. That abbreviated timeline is the result of production boosts and a bonus sixth dose found in vials of Pfizer's vaccine, the representatives said. Those deliveries, originally pegged to arrive by the end of July, should now reach states by the end of May.
Moderna is in talks with South Korea to build out a $200-million vaccine manufacturing facility—potentially in Seoul, Park Young-sun, a former government minister involved in the talks, told the Asia Business Daily. It's unclear when the plant could come online or how many doses it might produce. Story
South Korea on Friday authorized Celltrion's COVID-19 antibody drug, Regkirona, though the company is still on the hook to supply phase 3 data, Korea Biomedical Review reports. The country's Ministry of Food and Drug Safety cleared the drug in mild patients in high risk groups, as well as adult patients with moderate symptoms.
Daiichi Sankyo snared an outsourcing agreement with AstraZeneca to produce the drugmaker's University of Oxford-partnered vaccine in Japan, Daiichi said Friday. Under the deal, the company's Daiichi Sankyo Biotech unit will crank out doses through the fill-finish step at a facility tapped in the Japanese Ministry of Health, Labour and Welfare's scheme "for developing and producing novel influenza virus vaccines.”
AstraZeneca, armed with results from a non-peer-reviewed study, recently suggested its shot could curb the coronavirus' spread. Taking nasal swabs from vaccinated and unvaccinated people, AZ found positive tests were 50% lower among those who got two doses versus people who received no vaccine, making a case for the shot lowering transmission, it figures. Others aren't convinced. “What they show is that there was [either] decreased viral shedding or decreased detection of virus"—not decreased spread, Carlos del Rio, associate dean of Emory School of Medicine, told Time.
The world's approach to flu vaccines could provide a roadmap for the FDA's booster reviews, Politico reports. Yearly flu shots are based on a foundational vaccine that's altered to tackle the variants that emerge in a given season. Using this approach, drugmakers could skip lengthy trials enrolling thousands of subjects and instead prove safety and efficacy in smaller studies of a few hundred volunteers. “The flu model is the only thing that makes sense,” Paul Offit, M.D., told Politico, noting the challenge of running an efficacy trial now that many people have been vaccinated.
A slim 2.5% of the European Union's population has received a first vaccine dose, putting the bloc well behind the U.S., the U.K. and Israel. "We need to speed up vaccinations," Hans Kluge, the World Health Organization's European director, told news outlet AFP. Now, it's up to drugmakers to take part in efforts to "drastically increase production capacity," he said. He further recommended that wealthy nations share their shot supplies once they've vaccinated the elderly, healthcare workers and people with underlying conditions that put them at higher risk.
Norway won't give AstraZeneca's vaccine to people over the age of 65, the Norwegian Institute of Public Health (FHI) said Thursday. FHI cited a lack of older participants in AstraZeneca's trials as cause for its decision. So far, about 135,000 Norwegians have received their first shot, with some 35,000 getting their second dose—all of those with Pfizer and Moderna's vaccines, FHI said.
Police in Florida are searching for a man who stole a gray Hyundai Accent loaded up with 30 vials of Pfizer and BioNTech's CVOID-19 vaccine. The keys were left in the ignition, and the car was boosted from a vaccination site at the Strawberry Festival Fairgrounds in Plant City, authorities said. The 30 vials contained between 150 and 180 doses.
UPDATED: Thursday, Feb. 4 at 2:55 p.m. ET
As Roche weathers biosimilar pressure on key medicines, the pandemic took a toll on sales of drugs such as multiple sclerosis med Ocrevus and wet age-related macular degeneration treatment Lucentis. Many patients stayed home and didn't get treatments or didn't switch to new offerings, the company said in its fourth-quarter results. Story
As Novavax negotiates more supply deals for its coronavirus vaccine candidate, the company this week unveiled an agreement in principle with the Swiss government for 6 million doses. Novavax's vaccine was recently shown to be 89% effective in a late-stage study.
After officials in the Bolivian city of Trinidad last year started a campaign to give out free doses of Merck's anti-parasite drug ivermectin for COVID-19, the company says a data analysis doesn't support using the medicine against COVID-19.
While doctors in places around the country are still having a hard time getting doses of the coronavirus vaccine, one doctor in the remote town of Cut Off, Louisiana, got a shipment this week, he told Fierce Healthcare. Story
UPDATED: Thursday, Feb. 4 at 11:45 a.m. ET
Amid worries about vaccine supply constraints, U.K. researchers on Thursday kicked off a trial to assess a two-shot schedule combining Pfizer and AstraZeneca's shots. The study will look at the immune responses generated by an initial dose of Pfizer's shot, followed by AstraZeneca's—and vice-versa, at intervals of four and 12 weeks. Researchers plan to recruit some 800 participants and expect initial results by June. Story
AstraZeneca and the University of Oxford are working "as rapidly as possible" on next-generation COVID-19 vaccines to tackle emerging virus variants, Reuters reports, citing company research chief Mene Pangalos. “We’re working very hard, and we’re already talking about not just the variants that we have to make in laboratories, but also the clinical studies that we need to run,” he said during a media briefing. The company aims to have something ready by as early as autumn, he added.
Recruitment has picked up for Moderna's study assessing its mRNA vaccine in kids between the ages of 12 and 17, a company spokeswoman told the Boston Globe. The company aims to recruit 3,000 subjects and expects to deliver results by the middle of the year, she said. Pfizer last month finished recruitment for a trial of its own shot in children ages 12 to 15.
When the FDA cleared the use of a sixth dose in Pfizer's vaccine vials, demand spiked for special syringes needed to stretch supply. Thing is, the company had been working on a way to extract that bonus dose months before pharmacists had the idea themselves, The Washington Post reports. “I think this could have been anticipated. … It’s one more thing that was lost in the woodwork during the vaccine response,” former FDA staffer Jesse Goodman said. Meanwhile, Biden officials last week said they'd secured enough low-dead-space syringes to accompany all Pfizer shipments.
Pfizer won't stop testing its shot against emerging variants anytime soon, the company's vaccine chief, Philip Dormitzer, M.D., Ph.D., told ScienceInsider. Lab tests have so far shown South African and British variants could reduce efficacy, though the company doesn't think it needs to alter its shot just yet, he said. The company is running tests on a variant first observed in Brazil, too, and expects to unveil South African and Brazilian data imminently. "At the rate that this virus is spinning out variants, we will be continuing to do this for quite some time," Dormitzer added.
UPDATED: Wednesday, Feb. 3 at 3:30 p.m. ET
The European Medicines Agency's human medicines committee (CHMP) kicked off a rolling review of Novavax's shot, NVX-CoV2373, basing its decision on preclinical and early clinical data showing the vaccine triggers an antibody and immune cell response against the virus that causes COVID-19. The EMA will evaluate Novavax's clinical data as it comes in until there's enough evidence for a formal marketing authorization application.
Switzerland stopped short of approving AstraZeneca's vaccine as it awaits additional efficacy and quality data from North and South American trials, drug regulator Swissmedic said Wednesday. “As soon as the results have been received, a temporary authorization according to the rolling procedure could be issued at very short notice,” Swissmedic said. Meanwhile, the country bought 5 million CureVac doses, 6 million more Moderna doses and forged a preliminary pact for 6 million Novavax doses, for a total supply of more than 30 million shots.
Bristol Myers Squibb picked up the global rights to a pair of early-stage antibodies discovered by The Rockefeller University. The parties are keeping financial details close to the vest, with Rockefeller in line for sales royalties should the product hit the market. The university last month kicked off a 15-subject phase 1 study to assess subcutaneous and intravenous delivery of several doses of the two antibodies. If a low-dose subQ formulation is effective, which preclinical data suggest, BMS could be able to deliver large volumes of the product at a relatively low cost. Story
Biogen's spinal muscular atrophy blockbuster Spinraza took a fourth-quarter sales hit courtesy of COVID-19. Sales of the drug slipped 34% compared to the same period last year, with the "majority" of that decline due to patients opting out of treatment center visits during the pandemic, CEO Michel Vounatsos said on an analyst call. He said COVID-19 was “accelerating switches to alternative treatment,” too, such as Roche's oral competitor Evrysdi. Meanwhile, Novartis' gene therapy rival Zolgensma has also turned up the heat on Biogen's drug. Story
Meanwhile, GlaxoSmithKline's shingles vaccine Shingrix posted 11% sales growth in 2020, signaling a slowdown for a product that more than doubled sales in 2019. Pandemic lockdowns had a hand in slashing vaccination numbers, and the company expects Shingrix disruptions to persist in the U.S. until at least the back half of 2021. While sales did tick up in the fourth quarter, governments prioritizing COVID-19 vaccinations will likely take a toll on "all adult vaccinations, including Shingrix," Luke Miels, GSK's president of pharmaceuticals, told investors Wednesday. Story
AstraZeneca's vaccine was 54.9% effective in trial subjects who got their second dose within six weeks of the first—and that figure jumped to 82.4% in patients who waited 12 or more weeks, new data published in Preprints with The Lancet showed. A standard dose was found to be 76% effective between 22 days and 90 days after the first injection, offering protection while people wait on a booster. The data support AZ chief Pascal Soriot's recent recommendation that the European Union vaccinate as many people as possible now without holding back booster doses. Story
Serum Institute of India will provide 1.1 billion doses of AstraZeneca and Novavax's vaccines to the World Health Organization's equitable shot distribution scheme, Covax, UNICEF chief Henrietta Fore said Wednesday. Those deliveries will roll out over several years with individual doses priced at around $3 for low- and middle-income countries, she said.
BD is rolling out a new COVID-19 blood test in Europe designed to help hospitals flag patients who are more likely to require intensive care with a ventilator and are at higher risk of death. The test evaluates a person's immune system by measuring the percentages and absolute counts of T, B and natural killer cells, plus subpopulations of T cells in peripheral blood. Researchers at BD have found that the risk for ventilation or death spikes if CD4 T-cell counts drop below 250 per microliter or if CD8 cells are under 100 per microliter. Story
UPDATED: Wednesday, Feb. 3 at 9:30 a.m. ET
GlaxoSmithKline is paying CureVac up to €150m ($180 million) to co-develop next-generation mRNA vaccines against COVID-19, with a focus on emerging virus variants. The partners will develop a number of candidates, which they figure could protect people who haven't been vaccinated or serve as boosters if immunity wanes over time. Meanwhile, GSK has also tapped its Belgian manufacturing network to help produce up to 100 million doses of CureVac's first-generation mRNA shot in 2021. Story
Evotec subsidiary Just-Evotec Biologics bagged a $28.6 million contract from the Department of Defense (DOD) to help produce COVID-19 antibody drugs. Just-Evotec will set aside present and future manufacturing capacity at its soon-to-be-completed J. POD facility in Redmond, Washington, for the next seven years. The DOD first tapped Just-Evotec in July 2020 to help pinpoint potential antibodies—a move that yielded "rapid process development and manufacture of high yielding mAbs against SARS-CoV-2," the company said.
A recent Tweet got people wondering why more drugmakers haven't stepped up to produce COVID-19 vaccines:
The vaccine shortage doesn't need to exist. Pfizer and Moderna could share their design with the dozens of other pharma companies who stand ready to produce their vaccines and end the pandemic.— James Hamblin (@jameshamblin) February 2, 2021
Thing is, that's just wrong, medicinal chemist Derek Lowe wrote in his long-running "In the Pipeline" blog. There aren't "dozens" of companies ready to produce Pfizer and Moderna's shots because making an mRNA vaccine is both a new and complex process, which requires special equipment that most companies simply do not have. He pointed to the step where lipids and mRNA are combined into lipid nanoparticles as a particularly challenging bottleneck. Pfizer and Moderna both seem to be doing this step in-house, likely using "special-purpose bespoke" microfluidics devices.
The FDA slapped New Jersey's Eagle Pharmaceuticals with a complete response letter on its abbreviated new drug application for vasopressin, which the agency has flagged for its potential to treat COVID-19. Eagle has met twice with the FDA about the CRL and says it will hold an additional meeting within 30 days. The company will need to complete one additional short-duration study, which it plans to run in either mid-February or mid-March.
Mexico became the first North American country to authorize Russia's Sputnik V vaccine, the Russian Direct Investment Fund said Wednesday. The vaccine has so far been cleared in 17 countries including Russia, Hungary, Argentina, Bolivia and Palestine.
Delaying the second dose of Moderna's shot appears fine, but doing the same for Pfizer's vaccine could cause deaths and infections to spike, a study posted on the pre-print server medRxiv found. Other experts aren't convinced, National Post reports. The researchers' underlying assumption that Pfizer's shot is just 52% effective after the first dose is faulty, Julie Bettinger, a member of Canada's vaccine advisory board said. In fact, the first dose is closer to 90% effective after two weeks, Caroline Quach Thanh, M.D., chair of Canada’s National Advisory Council on Immunization, said.
Humanigen tapped CDMO Avid Bioservices to expand production capacity for its monoclonal antibody lenzilumab, designed to treat and prevent the immune hyper-response "cytokine storm." Avid will start tech transfer and analytical validation services with a view to produce drug substance batches for potential commercial supply, the companies said. Humanigen has fully enrolled a phase 3 trial of the drug and says it could file for an emergency use authorization later this year.
UPDATED: Tuesday, Feb. 2 at 3:15 p.m. ET
Taking a cue from Pfizer, Moderna hopes to raise the number of doses in its vaccine vials from 10 to upward of 15, The New York Times reports. As Moderna ramps up shot production, the fill-finish stage has become something of a bottleneck, hindering efforts to boost distribution in the U.S. Moderna has discussed the move with the FDA, but has yet to submit manufacturing data to get the change approved, sources close to the talks told the Times.
CDMO Catalent saw its biologics revenue jump to $403.9 million in the second quarter of its fiscal year, marking a whopping 76% increase at constant currencies over the same period in 2019. That boost comes courtesy of the company's myriad COVID-19 manufacturing contracts, which include vaccine pacts with AstraZeneca, Moderna and Johnson & Johnson, CEO John Chiminski said on an earnings call. The company is also looking to rapidly bring additional shot capacity online at facilities in the U.S. and Europe, he said. Story
Australia's Ellume bagged a $231.8 million contract from the Biden Administration to set up its first U.S. production facility and deliver 8.5 million at-home tests. The FDA in December cleared Ellume's test to be sold over-the-counter and used solo, regardless of whether a person has symptoms. The diagnostic is designed to go from swab to result in about 20 minutes. The planned U.S. facility is expected to produce more than 640,000 tests per day before year-end, building on Ellume's current daily capacity of about 200,000 tests. Story
People who previously had COVID-19 may need just one vaccine dose to mount an effective antibody response, a study published on the pre-print server medRxiv found. Researchers reported that a single vaccine dose in patients with pre-existing immunity yielded antibody levels on par with—and sometimes exceeding—those seen in non-infected patients after their second dose. Changing the number of doses patients with pre-existing immunity receive could free up limited vaccine supplies, the authors suggest.
The U.S. Centers for Disease Control and Prevention is expanding efforts to track coronavirus variants, Director Rochelle Walensky, M.D., said. The agency now aims to sequence 7,000 coronavirus samples per week, up from just 251 during the week of January 10. As of last week, the CDC was working with commercial lab partners to overhaul its NS3 sequencing system to better catch virus variants, Walensky said. Its lab partners have pledged to analyze 6,000 samples per week by mid-February, she added.
It's tough to tell the flu and COVID-19 apart—something Roche's Genentech unit is stressing to patients in its new DTC campaign for influenza med Xofluza. A new TV spot takes an extra 15 seconds to say as much, and it encourages anyone experiencing flu-like symptoms to contact a healthcare provider. The pharma wanted to ensure viewers understand Xofluza doesn't treat COVID-19, Laura Sullivan, the drug's marketing director, said. Story
UPDATED: Tuesday, Feb. 2 at 11:21 a.m. ET
Pfizer expects to bag $15 billion in sales of its mRNA vaccine Comirnaty—and that number could be even higher, the company said Tuesday. In last year's fourth quarter, the shot contributed $154 million. The company based its $15 billion estimate—part of its 2021 guidance—on doses set to be delivered in 2021 through established contracts, but the estimate could grow "if additional contracts are signed," according to the company's investor presentation. Story
Canada aims to produce Novavax's vaccine at a new National Research Council plant in Montreal, CP24 reports. Prime Minister Justin Trudeau is expected to announce a deal with the company on Tuesday. The facility is designed to produce a slim 2 million doses per month and is still under construction, meaning production is still some two months out, CP24 said. Canada's supply worries have intensified as the European Union imposes export controls on COVID shots following a supply kerfuffle with AstraZeneca. Canada's Pfizer and Moderna doses are both made in Europe.
AstraZeneca's Chinese vaccine manufacturing partner, Shenzhen Kangtai, has completed a facility with capacity for 400 million AZ doses, the company said Tuesday. The expansion will allow Shenzhen Kangtai to double the capacity target it agreed to last year. AstraZeneca's vaccine could be approved in China by mid-2021, Reuters reports, citing comments made in November by Leon Wang, head of the company's China operation.
The U.S. has set aside 5.8 million Moderna doses for states this week, marking a 1.5-million-dose boost from the 4.3 million doses the company supplied last week, according to the CDC. Pfizer, for its part, provided just under 4.4 million vaccine doses this week, up 70,000 doses from what it delivered last week. "Yesterday, we announced a 16% increase in supply flowing to states every week for the next three weeks to a minimum of 10 million doses per week," White House COVID-19 response adviser Andy Slavitt said Wednesday at a press event.
Pfizer and Johnson & Johnson want to block shareholders from voting on resolutions that would force the companies to reveal the effect of government funding on vaccine pricing and access, Newsweek reports. Members of the shareholder activist group the Interfaith Center on Corporate Responsibility asked the companies for government funding receipts and how that funding could affect pricing. Pfizer and J&J both filed "no action requests" with the Securities and Exchange Commission in December. They've claimed the proposals attempt to "micromanage" the companies. Story
Against the pandemic backdrop, drugmakers have increasingly turned to PR communications to get out day-to-day messages about drug supply, patient support and more. For Evoke Kyne, whose client list includes COVID-19 bigwigs Johnson & Johnson and AstraZeneca, that means 20 recent hires across its specialty creative, digital, social and earned media teams, plus double-digit revenue growth in 2020. “In a time last year when many people couldn’t find work, our category found an abundance of needs," Maryellen Royle, partner and global head of operations, said. Story
UPDATED: Monday, Feb. 1 at 3:05 p.m. ET
China's Clover Biopharmaceuticals parted ways with GlaxoSmithKline's adjuvant in favor of one from Dynavax. Clover had been testing its vaccine candidate with adjuvants from both companies, but said it had settled on Dynavax's after weighing "manufacturing considerations" and reviewing vaccine data from phase 1, which assessed both shot boosters. Clover and Dynavax expect to start a phase 2/3 trial in the first half of the year. Story
Pfizer and Moderna will continue to lead COVID-19 vaccine sales, but AstraZeneca, Novavax and Johnson & Johnson's shots have blockbuster potential, too, analysts figure. Despite lower overall efficacy in phase 3 than its mRNA competitors, J&J's shot still provides a "compelling one-dose profile with much more straightforward distribution and logistics," SVB Leerink analyst Mani Foroohar, M.D., wrote Monday. AstraZeneca, for its part, could snag $1.9 billion in vaccine revenues this year, followed by $3 billion in 2022, fellow SVB Leerink analyst Andrew Berens predicted. Story
The Mayo Clinic and nference are expanding their data analytics partnership to tackle research projects in digital pathology and heart rhythm diagnostics. Last January, Mayo tapped nference to build an artificial intelligence-powered engine that would transform years of clinical records into an annotated database. In 2020, the companies used the system to answer questions about the COVID-19's long-term complications and more. For instance, nference’s platform found the virus’ favored ACE2 receptor spanned multiple tissues, from the airway to the gastrointestinal tract. Story
Pharma has gone all in on digital solutions during the COVID-19 pandemic, but that may not be working out so well for doctors, recent research from Indegene found. Forty-nine percent of physicians polled expressed dissatisfaction with the industry's social media engagement. Meanwhile, 46% of doctors said they weren't happy with marketing emails and 42% took issue with telephone sales calls with sales reps. Another 39% of physicians said they were unsatisfied with both websites and webinars. Story
The World Health Organization inked a deal with India's Premier Medical Corporation to help automate the company's manufacturing capacity. The agreement, which covers R&D, technology transfer and scale-up provisions, supports Premier's goal of delivering at least 250 million test kits at less than $2.50 apiece—less than half the cost of the rapid antigen tests from Abbott and SD Biosensor that are already prequalified by WHO. The company has current capacity for 3 million tests per month, which it hopes to boost to 10 million per month by 2021's third quarter. Story
China arrested more than 80 suspects thought to have manufactured and sold at least 3,000 counterfeit COVID-19 vaccines, The New York Times reports, citing China’s state-run news agency, Xinhua. The primary suspect, identified by the surname Kong, had been injecting saline into vials and pawning them off as vaccines since September, Xinhua said.
The U.S. has given about 30 million vaccine doses and, as of Sunday, has been averaging more than 1.3 million vaccinations per day in the past week—surpassing an average of less than one million per day two weeks earlier, The New York Times reports. The U.S. would be in good shape were it not for looming virus variants. With the possibility that those mutations become dominant this spring, "we really have to vaccinate the American population by late spring, early summer," Peter Hotez, M.D., Ph.D., a vaccine scientist at Baylor College of Medicine in Houston, said.
And just as the U.S. was correcting the course on its vaccine rollout, a blizzard hit. New York City is postponing COVID vaccinations scheduled for Monday and Tuesday as snow blankets the city, Mayor Bill de Blasio said. The winter storm has also hamstrung vaccination efforts in New Jersey, Washington, Philadelphia and other areas, The New York Times reports.
Rep. Stephen Lynch, D-Massachusetts, tested positive for COVID-19 after getting both doses of Pfizer and BioNTech's shot, the lawmaker's spokesperson said. Lynch is asymptomatic and feeling fine, and he'll self-isolate and vote by proxy in Congress this week, she added. It can take a few weeks for the body to develop immunity after vaccination, the CDC has noted. "That means it's possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and still get sick," the agency said.
UPDATED: Monday, Feb. 1 at 11:40 a.m. ET
Eli Lilly has joined forces with local health systems to launch dedicated infusion centers serving central, northern and now, southern Indiana—part of a bid to increase access to antibody drug bamlanivimab. The rollout of Lilly's antibody drug and Renegeron's antibody cocktail has been slow, with infusion presenting one significant barrier to access, experts have noted. Lilly's local partners include the State of Indiana, Community Health Network, Eskenazi Health, Franciscan Health, Saint Joseph Health System and more. Story
Amid a European supply kerfuffle, AstraZeneca will send 9 million more vaccine doses to the European Union in the first quarter, increasing deliveries from February to March by about 30%, European Commission chief Ursula von der Leyen said. Deliveries will also kick off a week earlier than expected, she said on Twitter. The company is also working to boost production capacity in Europe, von der Leyen added.
Step forward on vaccines.@AstraZeneca will deliver 9 million additional doses in the first quarter (40 million in total) compared to last week’s offer & will start deliveries one week earlier than scheduled.— Ursula von der Leyen (@vonderleyen) January 31, 2021
The company will also expand its manufacturing capacity in Europe.
Bayer will produce German compatriot CureVac's mRNA shot starting in 2022. The company has "necessary capacities" in place to crank out the experimental vaccine, CVnCoV, and aims to produce 160 million doses in the first 12 months, Stefan Oelrich, Bayer's pharmaceutical head, told reporters. CureVac pushed its shot into a phase 3 trial in December and has set the goal to produce several hundred million vaccine doses through 2021, CEO Franz-Werner Haas said. Story
Speaking of CureVac, the mRNA specialist said Monday that it had started setting up manufacturing capacity with CDMO Rentschler Biopharma—on the hook for large-scale production of the formulated mRNA for CureVac's shot. The companies in December agreed to set aside production lines at Rentschler's site in Laupheim, Germany, where the CDMO aims to crank out more than 100 million doses of CureVac's vaccine per year.
Meanwhile, Pfizer's German mRNA partner BioNTech will boost second-quarter vaccine deliveries to the European Union by up to 75 million doses, the company said Monday. The move comes as Germany and other EU member states lag behind Israel, the U.K. and the U.S. with their vaccine rollouts. AstraZeneca recently said it would cut initial deliveries to the bloc, citing manufacturing shortfalls in Europe, while Pfizer and BioNTech said they would temporarily squeeze early shipments to Europe, Canada and other countries as they complete a factory upgrade in Belgium.
The World Health Organization's equitable vaccine distribution scheme Covax plans to distribute 35.3 million doses of AstraZeneca's vaccine to to 36 Caribbean and Latin American states from mid-February to the end of June, WHO's regional office said. WHO is expected to finish its review of AZ's shot for a possible emergency listing in the next few days, the Pan American Health Organization said. Meanwhile, Bolivia, Colombia, El Salvador and Peru will also get a combined 377,910 doses of Pfizer and BioNTech's mRNA shot from mid-February.
Vaccine specialist Dynavax Technologies tapped the Coalition for Epidemic Preparedness Innovations (CEPI) to support supply of Dynavax's CpG 1018 advanced adjuvant, pegged for use in COVID-19 vaccines developed by CEPI grantees. CEPI will provide a forgivable loan of up to $99 million for the potential manufacture of "hundreds of millions" of vaccine doses through 2021, the companies said.
The dry-ice needed to transport Pfizer's vaccine at ultra-cold temperatures is putting a squeeze on the frozen food industry, Modern Retail reports. The same week in December when dry ice manufacturer ThermaFreeze's stock jumped to $32.25, up from $0.80 per share the previous month, frozen waffle maker Evergreen said it would delay shipments of the breakfast food thanks to a lack of dry ice at its warehouse—and that's just one example.
UPDATED: Friday, Jan. 29 at 11:20 a.m. ET
Johnson & Johnson's single-dose vaccine candidate was just 66% effective overall in moderate to severe COVID-19 cases, with that number rising to 85% in severe disease, phase 3 data showed. The shot proved 72% effective at preventing moderate to severe COVID-19 in the U.S., but its overall effectiveness fared worse outside the country, with 66% efficacy in Latin America and 57% efficacy in South Africa. The shot performed better against severe disease, displaying “(c)omplete protection against COVID-19 related hospitalization and death” after 28 days, J&J said. Story
Speaking of J&J, the company plans to deliver some 200 million vaccine doses to the U.S., should its candidate snare an emergency nod. The order volume appeared in a footnote in a Government Accountability Office report published Thursday. Meanwhile, a spokesperson for the company told BNN Bloomberg that J&J plans to supply the U.S. with 100 million doses in the first half the year.
Amid supply concerns in Europe, AstraZeneca's COVID-19 vaccine won a conditional approval from regulators there on Friday. The approval was widely expected, and the regulators didn't add an age restriction for people 65 and older. There had been a question about the age group after German officials raised concerns over a lack of data. AZ's shot is now authorized for people 18 and older in Europe.
Novavax's shot candidate hit 89.3% efficacy in phase 3. In the 15,000-subject U.K. study, there were 56 COVID-19 cases in the placebo arm, versus six in the vaccine group at the interim analysis. Thirty-two of those cases were infected with the virus variant first ID'd in the U.K., with a post hoc analysis putting the efficacy against the B.1.1.7 variant at 85.6%, compared with 95.6% in older variants, Novavax said. Meanwhile, the shot was only 49.4% effective against the South African variant, data from a 4,400-subject phase 2b showed. Story
First Sanofi, now Novartis: The Swiss Pharma juggernaut has signed on to help Pfizer and BioNTech crank out their COVID-19 vaccine, Comirnaty. Under the deal, BioNTech will use Novartis' production facility in Stein, Switzerland. Manufacturing will start in the second quarter, with deliveries pegged to kick off in Q3. Novartis will receive bulk mRNA active ingredient from BioNTech and fill it into vials, which it will then bounce back to BioNTech for global distribution. Novartis is in "advanced" talks to support other companies developing COVID vaccines and drugs, too. Story
South Korea's Ministry of Food and Drug Safety recommended Celltrion's antibody therapy Regkirona, also known as CT-P59, to treat patients with moderate disease, plus those with mild symptoms who are in high-risk groups, Korea Biomedical Review reports. More data is needed to confirm the drug's preventative effect, as well as its efficacy in patients with mild COVID-19, an advisory committee reviewing Regkirona said. The drug regulator could authorize Regkirona once Celltrion submits phase 3 data, the head of the review committee said.
Pfizer and BioNTech's mRNA shot Comirnaty looks as safe in the real world as it did in clinical trials, and no new side effects have emerged, the European Medicines Agency said in its first safety update on a COVID-19 vaccine. EMA's safety committee, PRAC, assessed reports of deaths after receiving the shot, including deaths in frail, older patients, and found that there was no link between those cases and the vaccine.
Amid an ongoing vaccine supply row with the European Union, AstraZeneca published the contract it signed with the bloc last August. The contract allows EU member states access to up to 300 million vaccine doses, with the option to buy 100 million more. AZ last week said it planned to cut initial deliveries to the EU from 80 million doses to 30 million, blaming production shortfalls at its European manufacturing operations.
The U.K.'s top priority is to vaccinate its own population, but the country will help its "friends and neighbors" with shot supplies where it can, The Herald reports, citing Home Office Minister Lucy Frazier. The move comes after the European Union called on AstraZeneca to divert vaccine doses made in the U.K. to Europe. Meanwhile, Scotland plans to start publishing AstraZeneca's supply data next week in the interest of full transparency, the country's First Minister, Nicola Sturgeon, said.
AstraZeneca, for its part, offered the European Union an extra 8 million vaccine doses to help ease supply concerns, but that number is still far below what the bloc is looking for, an EU official told Reuters. The drugmaker said it could potentially bump up first-quarter deliveries to 39 million doses, but that still comes in well below the 80-million-dose minimum it had originally promised to deliver in that time, the official—who was directly involved in the talks—told Reuters.
UPDATED: Thursday, Jan. 28 at 3:10 p.m. ET
Amid concerns about supply of AstraZeneca's COVID-19 vaccine in Europe, a new wrinkle has emerged for the forthcoming rollout. German officials recommended against the vaccine's use in people 65 and older, citing a lack of evidence in the age group, UPI reports. AstraZeneca responded that the conclusion is "not an accurate reflection of the totality of the data."
After news that AZ won't be able to fulfill its first-quarter order in Europe, officials are facing pressure to restrict exports of COVID-19 vaccines, Sky News reports. Officials are also investigating the plant in Belgium at the root of the manufacturing issue.
The South African COVID-19 variant that has raised scientists' concerns has been found in the U.S., the Wall Street Journal reports. Two people with no connections and with no travel history to South Africa have been identified to have the variant, according to the report.
Supply shortfalls aren't just hitting Europe. Canada's first-quarter deliveries of Pfizer's mRNA could come up 500,000 doses short, an official said.
UPDATED: Thursday, Jan. 28 at 11:45 a.m. ET
Swiss Pharma Novartis is in talks with several companies to potentially chip on manufacturing for COVID-19 diagnostics and vaccines, a company spokesperson told Fierce Pharma. It isn't the company's first pandemic push, though. Last year, Novartis' gene therapy unit AveXis agreed to produce an early-stage COVID-19 gene therapy under investigation by researchers at Massachusetts General Hospital and Massachusetts Eye and Ear. Story
Separately, the U.S. government is considering leveraging the Defense Production Act to tap drugmakers to produce Pfizer/BioNTech and Moderna's vaccines. The Biden Administration is “not afraid to explore every option to get more vaccines to the public as quickly as possible," White House senior COVID-19 advisor Andy Slavitt said at a media briefing this week.
French vaccine specialist Valneva kicked off production of its inactivated, adjuvanted vaccine candidate. At the same time, the company announced it had finished enrollment for its phase 1/2 clinical trial and expects to report initial results in April. The company has recruited 150 healthy adults between the ages of 18 to 55 for the study, which launched in December. Valneva has agreed to supply up to 190 million doses of its shot to the U.K. and is in "advanced" talks with the European Commission to provide up to 60 million doses, should the vaccine win out in the clinic.
The European Union should "explore all options" and use "all legal means" to ensure it gets the vaccines it ordered, European Council President Charles Michel wrote in a letter to four EU leaders. This could result in the EU blocking vaccine exports if they violate existing contracts between drugmakers and the bloc, an EU official told Reuters. The European Commission on Friday is expected to outline criteria it would use to assess those exports.
The Belgian government on Thursday said it had inspected the local Novasep facility at the center of AstraZeneca's European vaccine delivery woes. Experts from the country's federal medicine agency will now work with Dutch, Spanish and Italian experts to deliver a report in the next few days, aiming to assess whether production shortfalls are truly behind AstraZeneca's reduced shipments, a spokesperson for Belgium's health minister said. AZ last week said it would cut initial shot deliveries to Europe from 80 million to 31 million doses, citing reduced manufacturing yields in Europe.
AstraZeneca has rejected the EU's recommendation to divert vaccines from its U.K. manufacturing sites to Europe, Bloomberg reports. The European Union has alleged that AstraZeneca used EU funding to boost production in the U.K. “We regret the continued lack of clarity on the delivery schedule and request a clear plan from AstraZeneca for the fast delivery of the quantity of vaccines that we reserved for the first quarter,” EU health commissioner Stella Kyriakides said.
It's now suspected that anti-vaxxers were behind a bomb hoax that forced Wednesday's evacuation of a Wockhardt facility in Wrexham, Wales, where the company is finishing doses of AstraZeneca's vaccine, The Telegraph reports. "Unfortunately there are anti-vaxxers out there, which is why security is being taken so seriously at this plant," a source told the British daily. The contents of the package, which weren't actually viable as a bomb, are now being investigated to track down the responsible parties. Wockhardt's manufacturing schedule wasn't disrupted.
The U.K. will offer genomic sequencing capacity to other countries to support the tracking of coronavrius variants, Pharma Times reports. The so called New Variant Assessment Platform will be led by Public Health England alongside NHS Test and Trace, plus academic partners and the World Health Organization’s SARS-CoV-2 Global Laboratory Working Group. Countries will be able to apply for assistance through WHO if they don't already have an established channel in the U.K., the news outlet said.
Pfizer and BioNTech's vaccine was largely effective against virus mutations first identified in the U.K. and South Africa, a lab study found. While the antibodies generated by the vaccine worked slightly less well against mutations found in the South African variant, the “findings do not indicate the need for a new vaccine to address the emerging variants,” Pfizer said. Meanwhile, both Moderna and Pfizer are investigating booster shots to tackle virus variants.
UPDATED: Wednesday, Jan. 27 at 3:07 p.m. ET
Sanofi signed on to produce more than 100 million doses of Pfizer and BioNTech's vaccine in Europe this year, with the first batches pegged for delivery from the drugmaker's Frankfurt, Germany, site by August, a Sanofi spokesperson told Fierce Pharma. Sanofi's own vaccine candidates remain top priority, he added. A phase 2b study of Sanofi and GlaxoSmithKline's experimental shot is scheduled to start next month, and the company also has a Translate Bio-partnered mRNA candidate in the pipeline. Story
Regeneron's antibody cocktail was mostly effective against viral variants first identified in the U.K. and South Africa, Regeneron and Columbia University researchers independently confirmed in lab tests. Both antibodies in the company's imdevimab and casirivimab cocktail demonstrated neutralizing activity against the B.1.1.7 variant, first discovered in the U.K. The cocktail was effective against the South African variant, B.1.351, too, although the potency of casirivimab was reduced.
Eli Lilly is teaming up with GlaxoSmithKline and its partner Vir Biotechnology to test Lilly's authorized antibody drug, bamlanivimab, in combination with GSK and Vir's experimental antibody therapy VIR-7831. The companies will assess the combo in Lilly's Blaze-4 trial to determine whether the two neutralizing antibodies bind to different epitopes of the coronavirus's spike protein, which could improve potency and lower the odds of viral variants evading treatment. Story
Spanish drugmaker PharmaMar's myeloma drug plitidepsin displayed anti-SARS-CoV-2 activity 27.5 times more potent than Gilead Sciences' Veklury (remdesivir) in human cells, researchers from the Icahn School of Medicine at Mount Sinai and the University of California, San Francisco found. The researchers published their study in Science and, in a separate paper posted on bioRxiv, said the drug also showed antiviral activity against a virus variant first identified in the U.K. PharmaMar says it's now in talks with regulators to launch a phase 3 study of plitidepsin in COVID. Story
CDMO Lonza is on track to get two more production lines for Moderna's vaccine up and running at its Visp, Switzerland, site this quarter, though it may take "a couple months" for the site to reach "cruising speed," CEO Pierre-Alain Ruffieux told reporters Wednesday. The company recently said it started manufacturing work using its first new Swiss line; once the other two become operational, the company will have total capacity for 400 million doses per year across Europe and the U.S. Story
AstraZeneca tapped virtual trial specialist Care Access Research to hustle along a U.S. study of the company's late-stage monoclonal antibody combo, AZD7442. Care Access will leverage its siteless approach for the phase 3, which is targeting more than 1,000 patients in the U.S. and the U.K. The company's so called "Mobile Sites on Demand" capability brings research—including people, equipment, software and processes—to places and communities that would otherwise have limited access to clinical studies. Story
Police evacuated Wockhardt's Wrexham, Wales, facility—tapped for fill-finish work on AstraZeneca's vaccine—after the company received a suspicious package, the BBC reports. A bomb squad was deployed, with police later stating the package was made safe and that its contents would be "taken away for analysis." Wockhardt said its staff was able to return, adding that its production schedule hadn't been disrupted.
Europe cleared Abbott Laboratories' rapid Panbio antigen test for both self-performed screening under supervision and widespread use by people without COVID-19 symptoms. The lateral flow test, which is similar to Abbott's U.S.-authorized BinaxNOW test, uses a nasal swab, which is plugged into the small, portable device to deliver a visual result in about 15 minutes. Abbott plans to pair its rapid tests with a smartphone app called Navica that will allow people to display their results. Story
UPDATED: Wednesday, Jan. 27 at 11:30 a.m. ET
Pfizer and BioNTech are working a booster shot to tackle coronavirus variants, Pfizer told Reuters. “We are already laying the groundwork to respond quickly if a variant of SARS-CoV-2 shows evidence of escaping immunity by our vaccine,” the company said. Meanwhile, the company still needs work with regulators to hammer out studies for the booster. Story
The U.S. aims to buy another 200 million doses from Pfizer and Moderna, which would raise the country’s total supply to 600 million doses, President Joe Biden said. The move comes as Biden confirmed the government will boost the number of doses going out to states from 8.6 million per week to 10 million for the next three weeks. Story
AstraZeneca reportedly bailed on a meeting with the European Union to talk about the reduction in its vaccine delivery volume, The Irish News reports, citing an EU official. The European Union would “insist on them” coming back for discussions should AZ’s vaccine get approved, the official said. Meanwhile, ABC News reported that AstraZeneca said it hadn’t pulled out of talks and was planning for a meeting later Wednesday.
The story took another turn when Austrian health minister Rudolf Anschober told reporters that AstraZeneca had simply delayed the meeting. “AstraZeneca has postponed today’s round of negotiations until tomorrow,” he said. “From my point of view that is not a big problem.”
Meanwhile, AstraZeneca never committed to a hard timeline for its vaccine deliveries in Europe, CEO Pascal Soriot told la Repubblica Tuesday. "Our contract [with the European Union] is not a contractual commitment. It's a best effort,” he said. “In fact, getting there, we are a little bit delayed." Because the U.K. inked its purchase with AstraZeneca early, the company had a “head start” on resolving supply chain issues that are now plaguing the EU, Soriot said. Story
Meanwhile, some of the details Soriot revealed in his interview were confidential, Reuters reports, citing an EU official. The bloc is now requesting that AstraZeneca publish its contract with the European Union, the official said.
Japan’s JCR Pharmaceuticals will produce 90 million doses of AstraZeneca and the University of Oxford’s vaccine, Nikkei Asia reports. JCR will then send the doses it makes to Japanese compatriots Daiichi Sankyo and Meiji for finishing and packaging, though it will likely take until May for the locally produced vaccine to be distributed, Nikkei said. The country in December agreed to purchase 120 million doses of the shot.
Bharat Biotech’s vaccine Covaxin neutralized a U.K. variant of the coronavirus, a lab study posted on bioRxiv showed. The company, alongside the Indian Council of Medical Research and the National Institute of Virology, Pune, assessed blood samples from 26 people who’d received Covaxin against the mutant virus. Bharat’s vaccine was approved in clinical trial mode earlier this month, raising concerns about the shot’s efficacy.
India’s Dr. Reddy’s Laboratories canned its COVID-19 study of Fujifilm’s flu med Avigan in patients with moderate to severe symptoms in Kuwait after the drug failed to hit its primary endpoint. Patients on Avigan saw sustained improvements in oxygen levels at the seven-day mark, compared to the placebo arm’s eight. The company plans to continue a phase 3 trial in the U.S. in an outpatient setting.
UPDATED: Tuesday, Jan. 26 at 3:19 p.m. ET
Regeneron unveiled early phase 3 data supporting the use of its antibody cocktail for "passive vaccination." REGEN-COV was 100% effective at preventing COVID-19 symptoms versus placebo in the trial, which assessed the drug in people at high risk of contracting the disease from exposure to infected family members. Passive vaccination with the drug slashed the overall rate of infection by half, and infections in patients on the cocktail were asymptomatic, brief and had a “short duration” of viral shedding, which can lead to the illness' spread, the company said. Story
Meanwhile, a combination of two Eli Lilly antibodies led to a 70% reduction in the risk of COVID-19 hospitalization or death, phase 3 data showed. In the study of more than 1,000 high-risk patients recently diagnosed with COVID-19, 11 people given a combination of bamlanivimab and etesevimab were hospitalized and none died, compared with 26 hospitalizations and 10 deaths in the placebo arm. The antibody duo also reduced viral load and improved resolution of symptoms. Story
Ahead of Johnson & Johnson's vaccine readout, now pegged for early next week, chief financial officer Joe Wolk said the company is "optimistic" and expects to deliver "a very robust data set." An emergency nod for the company's single-dose shot could help ease early vaccination efforts. AstraZeneca, Pfizer and Moderna's vaccines all require two doses, and with many countries demanding more, supply is struggling to keep up. J&J, for its part, aims to deliver 100 million doses to the U.S. by the end of June and 200 million to the EU by year-end. Story
Speaking of Johnson & Johnson's supply commitments, the company is "very comfortable" with those deals and "well on track" to make its deliveries, CFO Wolk said on the company's Tuesday conference call with analysts. Aside from its commitments to Europe and the U.S., the company has also pledged 100 million doses to developing countries through Gavi, the Vaccine Alliance, with plans to start those deliveries in the year's second half. Future supply agreements present “somewhat of a fluid situation,” Wolk said, adding that the volume of doses would affect the selling price. Story
Pfizer shouldn't count an extra sixth dose in vials of its vaccine toward its U.S. supply contract "until the supply of specialized syringes meets that of Pfizer vials," watchdog Accountable Pharma said Tuesday. Pfizer was originally receiving $97.50 for the five doses in each vial but now stands to make $117 per vial "by counting an extra dose that may or may not be extractable," the watchdog said. BD, the world's largest syringe maker, recently told Reuters it lacks capacity to "substantially" boost U.S. supplies of low dead space syringes, needed to pull Pfizer's sixth dose.
States may start receiving more vaccines next week, The Washington Post reports, citing two people close to the plan. Weekly shot allocations are expected to jump from about 8.6 million doses to 10 million doses—an increase of about 16%. White House coronavirus response coordinator Jeff Zients is expected to call governors Tuesday to inform them of the boost, possibly thanks to the release of more Moderna doses, according to The Post's sources.
After 14 to 18 days, people who received one dose of Pfizer's vaccine were 33% less likely to be infected, Clalit, Israel's largest state-mandated health services organization, said. Clalit compared 200,000 people ages 60 and up who'd received their initial shot with another 200,000 people who hadn't been vaccinated. Maccabi Health Services separately reported a 60% drop in infectious 13 to 21 days after patients received their first shot. Among the 428,000 Israelis who got both doses, only 63 people became infected a week later, the Israeli Health Ministry and Maccabi said Monday.
A fast-spreading coronavirus variant first identified in Brazil has cropped up in the U.S., Minnesota officials announced Monday. Officials said they'd identified one person infected with the so called P.1 variant, and that the individual in question had a "recent travel history to Brazil." Separately, Minnesota has detected eight cases of a variant first ID'd in the U.K., which could become dominant in the U.S. sometime in March, the CDC has warned. Another mutation that emerged in South Africa has yet to appear stateside.
Meanwhile, the Centers for Disease Control and Prevention is stepping up surveillance and study of viral mutations, director Rochelle Walensky told Fox News. Working with the National Institutes of Health, the FDA and the Pentagon, the CDC will work to assess the effect of vaccines and therapeutics on coronavirus variants, she said. Concerns have mounted this week over the possibility that the variant detected in South Africa may evade antibody treatment and reduce the efficacy of vaccines.
UPDATED: Tuesday, Jan. 26 at 11:37 a.m. ET
Following a supply cut in Europe, AstraZeneca has offered to kick off vaccine deliveries on February 7, about a week earlier than originally planned, two European Union officials told Reuters. The EU has also pressed the company to divert doses made in the U.K. to the European Union, at least through March, though AZ hasn't said whether it will go that route. One of the sources, briefed on the talks, told Reuters AZ had revised its upward supply goals for February, while the second official, involved directly in discussions, said there was no offer to boost supplies.
On the heels of AstraZeneca's delivery reduction, the European Union is telling Pfizer and other drugmakers that they need permission from the bloc to export vaccine doses to the U.K., The London Economic reports. Pfizer, which is producing doses of its shot Comirnaty in Belgium, will need to offer "early notification" anytime it wants to ships EU-made doses to non-bloc countries, Stella Kyriakides, Europe's health commissioner, said.
Serum Institute of India is set to deploy 3 million AstraZeneca doses to Saudi Arabia in about a week, company CEO Adar Poonawalla told Reuters. Each dose will cost $5.25, he added. SII doesn't plan to divert any of its Covishield doses to Europe, despite AstraZeneca's recent vaccine supply woes there, because the move would siphon shots away from places like India and Africa, Poonawalla said.
AstraZeneca's shot is more than 8% effective in people over the age of 65, Germany's health ministry clarified after a major mixup by local news outlets Bild and Handelsblatt. The newspapers published separate stories citing the low figure, with Bild suggesting German officials were worried the shot would fail to win approval with the European Medicines Agency. It seems the journalists confused the 8% of patients in AZ's trial who were between the ages of 56 and 69 with efficacy data, the country's health ministry said.
The Bild and Handelsblatt reports are "completely incorrect," an AstraZeneca spokesperson told German news outlet DW. The company pointed to vaccine data published in The Lancet that showed 100% of older adults generated spike-specific antibodies after their second dose. The U.K.'s Joint Committee on Vaccination and Immunisation and the country's Medicines and Healthcare products Regulatory Agency both vouched for the shot's efficacy in people over the age of 65, AZ added.
Meanwhile, "we could and should have been better prepared for this pandemic," AstraZeneca chief Pascal Soriot said on a virtual panel, blasting the "me first" approach that many countries have taken. In particular, he called out subpar international collaboration and pandemic preparedness. Looking forward, world leaders should adopt lessons learned from COVID-19 and invest more heavily in early detection and prevention, he said.
Sweden halted its Pfizer vaccine payments as it works to determine just how many doses are in each vial, local newspaper Dagens Nyheter reports. The country wants to know whether it's been charged for an extra sixth dose found in vials—a dose Europe's drug regulator approved earlier this month—rather than the five doses it agreed to. The country is also pushing Pfizer and the European Commission to reach a definitive agreement on the dose count for each vial.
Providing its shot in a six-dose vial is Pfizer's best chance at stretching its vaccine supplies, company board member and former FDA commissioner Scott Gottlieb told CNBC. “The bottom line here is that this is a very scarce resource. We need to make sure every dose gets used,” he said. With approval for that sixth dose in place, Pfizer can now deliver 120 million doses in the first quarter, rather than 100 million, he said—but there's a catch: To pull out that extra dose, pharmacists need special low dead space syringes.
Moderna has delivered 30 million vaccine doses to the U.S. as of Tuesday, Bio Stocks reported on Twitter. The company is still on track to roll out 100 million doses by March and 200 million by the end of June.
$MRNA Provides U.S. #COVID19 Vaccine Supply Update.— Bio Stocks™ (@BioStocks) January 26, 2021
Company has supplied over 30M doses to U.S. Govt to date.
Remains on track to deliver 100M doses by end of March.
Remains on track to deliver 200M doses by end of June
Meanwhile, Johnson & Johnson aims to unveil phase 3 data on its single-dose vaccine hopeful next week, CFO Joseph Wolk said. Wolk restated that the price per regimen wouldn't surpass $10, adding that the company plans to onboard seven vaccine production facilities by end of the second quarter.
*J&J TO REPORT VACCINE DATA BY EARLY NEXT WEEK: CFO— zach (@zbiotech) January 26, 2021
*J&J TO ONBOARD 7 VACCINE PRODUCTION FACILITIES BY Q2 END: CFO
*J&J CFO: GUIDANCE DOES NOT INCLUDE COVID-19 VACCINE SALES
*J&J CFO REITERATES PRICE PER REGIMEN NOT TO EXCEED $10$JNJ
The World Health Organization now recommends that clinicians put COVID-19 patients in the awake prone position, on their front, to improve oxygen flow, and it's also vouching for the use of low-dose anticoagulants to prevent the formation of blood clots, WHO spokeswoman Margaret Harris said at a U.N. briefing. For patients who continue to display symptoms after recovery, WHO is pushing for the use of pulse oximetry, used to measure oxygen levels, to determine whether a person should be admitted to the hospital.
UPDATED: Monday, Jan. 25 at 3:15 p.m. ET
Merck & Co. canned both of its COVID-19 vaccine candidates, citing lackluster efficacy data in phase 1. The candidates, V590 and V591—developed with IAVI and picked up in Merck's Themis buyout, respectively—triggered immune responses inferior to those seen in infected patients. The responses were also weaker than those spurred by rival vaccines. Merck will now shift its attention to two experimental therapies in the works—a fusion protein it snagged in its OncoImmune takeover, and the Ridgeback Bio-partnered antiviral molnupiravir. Story
While Moderna's vaccine has so far stood up against two fast-spreading coronavirus variants, it's less effective against the more recently identified South African mutation, prompting the company to weigh a third shot and variant-specific booster. The variant candidate, designed to target the South African mutation, B.1.135, is moving into preclinical trials and a phase 1 U.S. study, Moderna said Monday. Meanwhile, Pfizer and BioNTech in December said testing had shown their mRNA vaccine, Comirnaty, consistently “neutralized multiple mutant strains.” Story
Upstart generics maker Civica Rx is plowing $124.5 million into a sterile injectables manufacturing plant in Petersburg, Virginia—part of its partnership with Phlow Corp to crank out essential meds for COVID-19. The 120,000-square-foot facility will have capacity for 90 million vials and 50 million pre-filled syringes per year, focusing on drugs for COVID-19 patients as well as meds used in emergency rooms, intensive care units and surgeries. The facility will ultimately employ more than 180 staffers once it comes online, sometime in the next three years, Civica said. Story
Scientists examining the immune system's effect on the microbiome found two molecules that could offer new treatment strategies for asthma and COVID-19. Upon transplanting gut bacteria from an immune-deficient mouse model into normal mice, the team found that the bacteria displayed enhanced metabolism of the molecule L-tyrosine, creating a byproduct called p-cresol sulfate (PCS). Both supplements protected against lung inflammation in asthma models and animal models of acute respiratory distress syndrome (ARDS)—a common byproduct of severe COVID-19. Story
President Joe Biden's quest to roll out 100 million vaccine doses in his first 100 days in office is "a floor... not a ceiling," which "reflects the realities of what we face, what could go right but also what could go wrong," Surgeon General pick Vivek Murthy told ABC. Approval of Johnson & Johnson's single-dose vaccine would help meet that goal, but it isn't essential given current supplies of Pfizer and Moderna's shots, he said. Meanwhile, establishing better distribution channels via mobile units and strategically-placed community vaccination centers will be equally essential, he added.
Italy is weighing legal action against AstraZeneca, which committed a “serious contractual violation” on Saturday when it told the country to expect 3.4 million vaccine doses in the first quarter, down from the 8 million it had hoped for, Prime Minister Giuseppe Conte said. The delivery reduction comes after Italy's COVID-19 commissioner, Domenico Arcuri, said the country was bracing for a 29% drop in Pfizer/BioNTech doses after this week.
The FDA rolled back its emergency authorizations for N95 respiratory decontamination systems, cutting down the number of times each mask could be safely reused to just four. Systems from companies like Battelle, Steris and Stryker kill viruses and bacteria on the masks by gassing them with hydrogen peroxide vapor. Early last year, when supplies of personal protective equipment were at a minimum, the agency allowed masks to be reprocessed up to 20 times on certain hardware. Story
When the city of Los Angeles converted Dodger Stadium from a testing center into a mass vaccination site, it temporarily removed about one-third of all government-funded testing in the county, Kaiser Health News reports. Less testing capacity could mean people have to wait longer for appointments, increasing the risk of potential spread. Those delays haven't happened yet, LA Mayor Eric Garcetti said; still, many health experts caution that testing is just as important as vaccination, especially as a tool to assess the longer-term efficacy of authorized shots.
On the East Coast, New York City will delay opening vaccination centers at Yankee Stadium and Citi Field, thanks to low vaccine supplies, mayor Bill de Blasio said. Another site at the Empire Outlets on Staten Island, originally pegged to open last week, has also been put on hold. On Monday, the city had 19,032 first doses on hand and expected to receive a little less than 108,000 more this week—not nearly enough to keep up with the pace of immunization, de Blasio said.
Want to watch the Miami Heat play? First, you need to pass the sniff test. The Heat will use coronavirus-sniffing dogs to screen fans hoping to attend games at the American Airlines Arena, The Boston Globe reports. The dogs were deployed earlier this season to screen small numbers of guests—mostly friends and family of Heat players and staff, though starting this week, a limited number of ticket holders will be allowed in.
UPDATED: Monday, Jan. 25 at 11:40 a.m. ET
Moderna says its vaccine appears to work against coronavirus variants first identified in South Africa and the U.K., citing new results from lab studies assessing the blood of eight patients who received the shot. The study showed no reduction in neutralizing titers against the B.1.1.7 variant, which first cropped up in the U.K. And despite a six-fold reduction in neutralizing titers against the South African variant, B.1.351, levels remained above those expected to provide protection, Moderna said.
Humanigen tapped Emergent BioSolutions to speed up production of the drugmaker's experimental antibody drug lenzilumab. Emergent's aim is to shore up supplies of the drug, currently in phase 3, ahead of a possible emergency nod in 2021's first quarter. For its seventh COVID-19 manufacturing tie-up, Emergent plans to leverage a new flex fill line at its Baltimore, Maryland, drug product manufacturing facility.
Korea's Daewoong Pharmaceutical got a thumbs up to run a phase 3 trial of its oral protease inhibitor, Foistar, in COVID-19 patients. The drug, approved in Korea in 2012 to treat chronic pancreatitis, will be given to 1,012 COVID patients across two Seoul hospitals starting in February. Daewoong has completed a phase 2 study of the drug in patients with mild symptoms, but it did not yield statistically significant data.
The European Medicines Agency could clear AstraZeneca's shot for emergency use on Friday, Yahoo! News reports, citing an official from Germany's health ministry.
Meanwhile, European Union chief Ursula von der Leyen spoke to AstraZeneca CEO Pascal Soriot Monday, clarifying that she expects the British pharma to fulfill its established orders to Europe, her spokesperson, Eric Mamer, said. Soriot said his company was doing everything possible to speed deliveries to Europe, though wider supply problems emerged Monday, Reuters reports.
Over the weekend, health commissioner Stella Kyriakides also wrote a letter to the company seeking "further clarifications," a Commission spokesman on public health said. In her letter, Kyriakides argued that production scale-ups have to happen "concurrently" with clinical trials to get doses out as quickly as possible, the spokesman said. Story
AstraZeneca also plans to cut supplies to Australia in March after the company said it was facing a "significant supply shock," the country's health minister, Greg Hunt, told reporters. Meanwhile, Thailand says it will now receive 150,000 AZ doses rather than an expected 200,000. AZ's EU delay is tied to reduced yields at a site run by its viral vector manufacturing partner Novasep.
Speaking of Australia, the country on Monday issued a complete approval for Pfizer and BioNTech's vaccine, which has largely been cleared for emergency use in countries where it's available. The country plans to vaccinate some 80,000 people per week starting in late February, Prime Minister Scott Morrisson said.
Pfizer will ship fewer vials of its vaccine to the U.S. than originally planned, thanks to updated FDA guidance allowing pharmacists to extract a sixth dose from the vials, which were originally designed to hold five. The FDA's decision marked an immediate 20% jump in Pfizer's vaccine capacity and now, the company is folding that extra dose into its overall order for 200 million U.S. shots by July, The New York Times reports. Story
So-called "low dead space" syringes are needed to pull out that sixth dose, and Pfizer on Friday finalized a deal with the Biden Administration to track shipments where the specialty injectors are available, a source close to the matter told The Washington Post. Shipments with regular syringes will count toward five doses, while those accompanied by low dead space syringes will count for six. Meanwhile, the administration on Friday said it would leverage the Defense Production Act to secure more of the devices.
Italy tweaked its vaccination plan to prioritize patients' second dose after Pfizer announced a temporary reduction in deliveries as it completes an upgrade on a Belgian manufacturing plant. Nearly 1.38 million doses have been administered so far, the country's deputy health minister Pierpaolo Sileri said. Among those, 100,863 people have received their second shot. The delivery adjustment has further prompted Italy to delay vaccination for people over 80 years old by four weeks, with a delay of six to eight weeks for the rest of the population.
Germany bought a combined 200,000 doses of Eli Lilly's antibody drug bamlanivimab and Regeneron's antibody cocktail for €400 million ($484 million). The move makes Germany the first European nation to purchase the drugs, which are cleared for emergency use in the U.S.
UPDATED: Friday, Jan. 22 at 3:23 p.m. ET
A new coronavirus variant that emerged in South Africa seems to evade treatment with convalescent plasma and may render the current vaccines on offer less effective, South African researchers wrote in a paper published on bioRxiv. “This lineage exhibits complete escape from three classes of therapeutically relevant monoclonal antibodies,” the researchers said, adding that the variant shows "substantial or complete escape" from antibodies in the plasma of recovered COVID-19 patients. That bodes ill for potential reinfection and the efficacy of spike-based vaccines, they said.
Chances are "very high" that a South African variant of the coronavirus is spreading in the U.S., Illumina CEO Francis deSouza told CNBC. "[The] reality is, in the U.S. we’re doing very little genomic surveillance," he explained. Sequencing giant Illumina has been working with the CDC to assess the prevalence of a variant first ID'd in the U.K., B.1.1.7, across the U.S., though efforts are lagging behind those of other countries. The U.K. is sequencing about 10% of the cases they see, while the U.S. currently sequences around 0.3% of positive cases, deSouza said. Story
With a European authorization looming, AstraZeneca notified EU officials this week that its first-quarter vaccine deliveries will be lighter than expected, thanks to "reduced yields at a manufacturing site within our European supply chain," a company spokesperson told Fierce Pharma. The company aims to supply "tens of millions" of doses to the EU in February and March as it continues to boost production volume, she added. The supply squeeze comes shortly after Pfizer and BioNTech reduced their own EU deliveries as they finish a plant upgrade in Belgium. Story
Eli Lilly is armed with data showing its antibody drug bamlanivimab can prevent symptomatic infections, but because those data are limited to long-term care facilities, where many are now getting vaccines, the drug may continue struggling to catch on. Getting the therapy to patients is its own challenge, SVB Leerink analyst Geoffrey Porges said in a note. “[T]his hinges on quick, targeted distribution... by the U.S. government, which is a significant unknown factor,” he said. The fact that the drug needs to be infused presents another distribution barrier, he added. Story
The pandemic put mRNA vaccines on the map last year, and the technology's future looks bright, experts said on a Fierce Pharma virtual panel. The manufacturing process for mRNA shots is "universal," Mariola Fotin-Mleczek, chief technology officer at CureVac, said, meaning different vaccines can be made at the same plant. IAVI's Swati Gupta thinks scientists will look to explore the platform beyond infectious diseases. Still, researchers shouldn't give up entirely on proven vaccine tech, Rajeev Venkayya, president of Takeda’s global vaccines business unit, said. Story
Facing the prospect of another year without in-person events, the Biotechnology Innovation Organization (BIO) has made "some staff reductions... to align the organization for the new strategic direction,” CEO Michelle McMurry-Heath, M.D., Ph.D, said. BIO currently has two in-person meetings lined up, though it “expects to offer virtual-only events throughout most of 2021.” Story
Walmart is gearing up to offer vaccines in Georgia, Indiana, Louisiana, Maryland, New Jersey, South Carolina and Texas, plus Chicago and Puerto Rico, a company spokesperson told Reuters. Healthcare workers can already get vaccines through the retailer in New Mexico and Arkansas. The company said Friday that it should be able to deliver 10 million and 13 million doses per month at full capacity.
UPDATED: Friday, Jan. 22 at 11:22 a.m. ET
Bharat Biotech's COVID-19 vaccine, authorized in India under the name Covaxin, proved safe and induced an immune response in phase 1, data published in the The Lancet Infectious Diseases journal showed. The shot was well-tolerated across dose groups and no serious safety events were reported. All side effects were mild to moderate and were more frequent after the first dose, Bharat said. Bharat's shot is currently in phase 3 testing and was approved in "clinical trial mode" just one day after India's drug regulator pressed the company for more efficacy data.
Five people are dead after a fire broke out in a building under construction at Serum Institute of India's (SII) headquarters in Pune. The blaze may have started as a result of welding work, CNN reports, citing Pune's mayor. Production of AstraZeneca's vaccine, which SII is cranking out under the name Covishield, won't be affected, CEO Adar Poonawalla said.
The European Commission wants clarity from Pfizer over further vaccine delivery delays reported by a handful of European countries, a European Union executive told Reuters. Originally, Pfizer and the Commission said delays would only occur this week as Pfizer scales up its Puurs, Beligum, plant. Italy has been told to now expect a 20% order reduction next week, while the Czech Republic said deliveries could drop by as much as 30% over the next two weeks.
Poland may sue Pfizer if it fails to make its vaccine deliveries on time, Piotr Müller, Poland's government spokesman, said. Poland received 176,000 doses of Pfizer's shot this week, down about 50% from what it expected. Pfizer has said it will temporarily squeeze shot deliveries to Europe and Canada as it completes a plant upgrade in Puurs, Belgium. Poland's health minister Adam Niedzielski on Thursday said the missing doses would be made up from mid-February, "but if this is not the case then of course legal measures will have to be considered,” Müller said.
France, meanwhile, could impose sanctions on Pfizer and BioNTech if vaccine shipments are further reduced, Clement Beaune, the country's minister for European affairs, told the Europe 1 radio network. That said, Pfizer's vaccine deliveries are expected to return to normal on Monday, he said.
European Union countries are scrambling to get their hands on low dead space syringes that would allow a sixth dose to be extracted from vials of Pfizer and BioNTech's vaccine, Yahoo! Finance reports. Europe's drug regulator on January 8 OK'd the use of a sixth dose from each Pfizer/BioNTech vial, originally meant to hold five. Meanwhile, countries will have to pay for that extra dose regardless of whether they have the syringes to make use of it, since the companies' supply commitments are "based on delivery of doses, not vials," Pfizer said.
UPDATED: Thursday, Jan. 21 at 2:10 p.m. ET
The challenges for antibodies from Regeneron and Eli Lilly have been well documented, and now a new wave of antibodies from AstraZeneca and other companies is in development to potentially solve that problem and the separate issue of viral mutations. A Regeneron spokeswoman said the company's antibody should stand up to known variants, while Eli Lilly's drug could be susceptible to the South African variant, a representative said. Story
Headlines about low vaccine acceptance have raised alarm in recent months, but amid the rollout, sentiment seems to be improving. In a new Harris Poll, researchers found a 69% acceptance rate for COVID-19 vaccines, just shy of the all-time high of 73%. Story
On the subject of vaccine acceptance, Pfizer and BioNTech are running their own effort with partners to encourage people to get vaccinated. The companies, together with a coalition of health organizations, recently debuted an unbranded awareness campaign that reminds people about the way life used to be. The partners plan 25- to 30-second videos outlining the possibilities following vaccination. Story
While President Joe Biden has his hands full with the COVID-19 pandemic, he has a talented group of advisors, as well. NIAID director Anthony Fauci is staying on board as chief medical advisor, and numerous other experts are joining the effort. Stat has a list of 10 key officials of note.
As the new administration pushes to vaccinate 100 million people in 100 days, new CDC director Rochelle Walensky said COVID-19 vaccines won't be in every pharmacy by the end of next month, NBC News reports.
UPDATED: Thursday, Jan. 21 at 11:15 a.m. ET
Eli Lilly's antibody therapy bamlanivimab cut the risk of symptomatic COVID-19 in nursing home residents and staff, data from the company's phase 3 Blaze-2 trial showed. Among 965 participants who tested negative at the start of the study—299 of them residents and another 666 staff—Lilly linked bamlanivimab to a roughly 57% reduction in risk of contracting symptomatic COVID-19 versus placebo. Among residents specifically, those treated with the drug were up to 80% less likely to develop symptomatic disease, Lilly said.
Adding Roche's arthritis med Actemra to standard care is no better than standard care alone at cutting death rates among the sickest COVID-19 patients, results from a small Brazilian study published in the British Medical Journal showed. Clinical outcomes among 65 patients who got the drug plus standard treatment failed to beat those in the control arm. The study, though small, contradicts results from a larger U.K. trial, which found the drug, as well as Sanofi and Regeneron's Kevzara, significantly curbed death risk in patients needing intensive care.
Among 189,000 Israelis screened for COVID-19 after receiving their first Pfizer shot, 12,400 people tested positive, the Israeli health ministry said. Most people contracted the virus shortly after their first dose, though around 1,410 tested positive two weeks after that, when the vaccine should have started taking effect. Meanwhile, another 69 people became infected after receiving both doses. The efficacy of Pfizer's shot climbs from 52% to 89% between day 15 and day 21 after patients get their first injection, the company has said.
The U.K.'s vaccine rollout dodged a major pitfall after rainwaters from Storm Christoph surrounded a Wockhardt manufacturing facility in Wrexham, North Wales, tapped for fill-finish work on AstraZeneca's vaccine. Emergency teams subverted flooding by establishing resources like gullies, the leader of Wrexham County Borough said. Meanwhile, a Wockhardt spokesperson told The Irish News that manufacturing hadn't been interrupted and no water made it inside. Story
South Africa will buy 1.5 million AstraZeneca shots from Serum Institute of India at $5.25 per dose, a senior health administration official said. Deliveries are expected to start before the end of the month. Meanwhile, South Africa is set to receive another slate of vaccines in March through the African Union. Under that deal, the country is expected to pay $3 per dose of AstraZeneca's shot.
Japan's Panasonic is leveraging its refrigerator tech to develop storage boxes for Pfizer's vaccine, which must be kept at a frigid -94 degrees Fahrenheit, The Asahi Shimbun reports. The box will incorporate dry ice to keep the shots cool and doesn't need to be plugged in, the company said. Samples will be ready in March, with a final product expected a month or two after that.
UPDATED: Wednesday, Jan. 20 at 3:08 p.m. ET
The premier of Ontario, Doug Ford, has asked President Joe Biden to share "a million" vaccine doses from Pfizer’s Kalamazoo, Michigan plant, after Canadian officials reported Tuesday that the country wouldn't receive any Pfizer doses next week and 50% fewer than expected over the next month. Pfizer recently confirmed a brief reduction in shot deliveries to Europe and Canada as it wraps a capacity upgrade on a plant in Puurs, Belgium.
Meanwhile, Italy plans to press charges both “civil and criminal, where possible” against Pfizer for delayed vaccine deliveries linked to its Belgian plant upgrade, Domenico Arcuri, Italy’s special commissioner for the pandemic, said in a statement. Italian officials discussed the delay with Pfizer Tuesday, but the talks “did not have the effect we were hoping for,” Arcuri wrote. He added that Pfizer would not make up the difference in deliveries next week.
President Joe Biden is putting science first in his efforts to curb the pandemic. Human Genome Project head Eric Lander, Ph.D., is Biden's pick for presidential scientific advisor, as well as director of the Office of Science and Technology Policy. Frances Arnold, Ph.D.—the first American woman to win the Nobel Prize in chemistry—and Maria Zuber, Ph.D., an expert in geophysics and planetary science, will serve as external co-chairs of the President’s Council of Advisors on Science and Technology. Francis Collins, M.D., will stay on as director of the NIH, while Janet Woodcock, M.D., appears the likely pick for FDA commissioner. Story
One challenge President Biden now faces? Convincing people to take an approved vaccine. Rather than focusing on straight talk and hard stats, vaccine campaigns should instead appeal to peoples' desire for a return to normalcy, execs from Digitas Health, McCann Health and Ogilvy Health told Fierce Pharma. “To overcome vaccine hesitation, you’re going to have to have a lot of different segmentation and a lot of different messages," Justin Freid, chief growth and innovation officer at CMI/Compas, added. Story
New York-based Ride Health, which works with a network of transportation providers to get patients to and from hospitals, is partnering with the NIH-backed ACTIV-2 study, assessing treatments for COVID-19, and the NIH-founded COVID-19 Prevention Trials Network. The goal is for Ride Health to provide transportation to and from study sites through its network of COVID-19-equipped providers, meaning drivers will follow guidelines from the CDC, plus state-mandated precautions. Story
India on Wednesday started exporting Serum Institute of India (SII)-produced doses of AstraZeneca’s vaccine to nearby countries. The first exported Covishield doses, set for delivery to Bangladesh, Bhutan, the Maldives, Myanmar, Nepal and the Seychelles, are being donated, India’s Foreign Ministry said. Several of those countries have separate vaccine orders on the docket or are in talks with Serum Institute. Bangladesh, for instance, expects to receive 2 million Covishield doses on Thursday and has separately purchased 30 million doses from SII.
COVID-19 vaccines from Moderna, AstraZeneca, Sinopharm and Sinovac are in the “final phase” of review for a possible emergency use listing by the World Health Organization, Reuters reports, citing an internal WHO document. The agency on December 31 cleared Pfizer and BioNTech’s mRNA-based vaccine for emergency use.
UPDATED: Wednesday, Jan. 20 at 11:16 a.m. ET
As states expand vaccine eligibility to people over the age of 65, older patients enrolled in Novavax's late-stage shot trial want to be "unblinded" and, if they received placebo, drop out to get Moderna or Pfizer's vaccine, The Washington Post reports. Recruitment of trial subjects has slowed, too. Novavax in December set out to recruit 30,000 people for its U.S. trial, including 25% in the over-65 category. As of last week, the company said it had enrolled 9,000 patients and would ask the FDA to weigh data from the same age group in a fully-enrolled U.K. trial if it missed its recruitment goal. Story
Pfizer and BioNTech's vaccine appears to work against a fast-spreading British variant of the coronavirus, further lab tests showed. The latest study, still awaiting peer review, used a synthetic virus with 10 mutations characteristic of the British variant. The antibodies in the blood of 16 patients who received Pfizer and BioNTech's vaccine, Comirnaty, neutralized the pseudovirus as well as they did the older version of the virus.
Japan secured another 24 million doses of Pfizer and BioNTech's mRNA vaccine, building on a previous order for 120 million doses, the country's health ministry said. The expanded order gives Japan enough doses of Pfizer's shot to vaccinate 72 million people out of its total population of 126 million, Nikkei Asia reports. Pfizer's vaccine is currently the one and only COVID-19 shot under review in Japan. The government is looking to kick off vaccination efforts by late February, Prime Minister Yoshihide Suga said.
Swedish biotech Cyxone has applied to run a phase 2 trial of its rheumatoid arthritis hopeful rabeximod in moderate COVID-19 patients requiring oxygen therapy who are not on mechanical ventilation. The aim is to see whether the drug could cut the risk of severe respiratory symptoms caused by immune responses run-amok. Cyxone will compare two doses of the drug against placebo in 300 subjects, with plans to release initial data in the third quarter of 2021.
The U.K. is more than halfway toward its goal of vaccinating 300,000 elderly nursing home residents, and mobile vaccination teams armed with AstraZeneca and the University of Oxford's shot have helped get it there, The Wall Street Journal reports. The shot doesn't need to be diluted, making delivery more efficient, plus, patients don't need to be monitored for anaphylaxis after getting their injection. AZ's vaccine remains stable for six month at fridge temps and can be used in smaller batches, too. This versatility has led to its prioritization for nursing home residents, WSJ said.
In searching for a fast-spreading British variant of the novel coronavirus, Californian researchers discovered the state had a mutation of its own, which may be responsible for a recent surge, The New York Times reports. The variant seems to have emerged in July but lay low until November, when it started to spread. The mutation, dubbed CAL.20c, accounted for more than half of the virus genome samples collected in Los Angeles laboratories on Jan. 13, the NYT said, citing a new study that has yet to be published.
The African Union has locked down 270 million vaccine doses beyond the World Health Organization's Covax distribution scheme, and each dose will cost member countries between $3 to $10, Reuters reports. Serum Institute of India will provide 100 million doses of AstraZeneca's vaccine for $3 per dose, while Pfizer is offering 50 million doses at $6.75 apiece. Finally, Johnson & Johnson will offer 120 million doses of its single-shot vaccine at $10 each.
UPDATED: Tuesday, Jan. 19 at 3:17 p.m. ET
A factory upgrade in Puurs, Belgium is putting a temporary squeeze on deliveries of Pfizer and BioNTech's shot to Europe, Canada and a few other regions, The Wall Street Journal reports. Unveiled last week, the Puurs expansion should start boosting output in February and is set to "significantly" increase deliveries in the first and second quarter, BioNTech said. Deliveries will return to normal starting next week, the companies added. Six EU countries were quick to hit back, calling the situation "unacceptable" in a letter to the companies, Reuters reports. Story
Pfizer supports President-elect Joe Biden's plan to roll out 100 million vaccine doses in his first 100 days in office, CEO Albert Bourla said. Biden on Thursday unveiled a $1.9 trillion plan to combat COVID-19, which includes federally-assisted vaccination centers, mobile clinics, an expanded healthcare workforce and more. As for whether available shot supplies support Biden's goal, “It will be a hefty lift, but we have enough to do that,” Rochelle Walensky, Biden's pick for CDC chief, told CBS' Face the Nation.
The World Health Organization's equitable vaccine distribution scheme Covax—co-led by Gavi, The Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI)—could soon secure doses of Pfizer and BioNTech's mRNA shot, senior adviser Bruce Aylward said. Covax aims to start deploying doses to low- and middle-income countries in February.
Pfizer and BioNTech will provide the FDA with a Biologics License Application—needed to snare full approval for their COVID-19 shot—in the first half of 2021, with a view to secure a green light in the second half of the year, the companies told Fox News.
Clinical trials combining AstraZeneca's COVID-19 vaccine with Russia's Sputnik V shot could kick off in early February, Alexei Repik, chairman of the Russian drugmaker R-Pharm, which is on deck to produce both vaccines, told Reuters. Researchers will look to recruit some 100 subjects for the first two phases of the study, which will take place in Azerbaijan, Argentina, Saudi Arabia, the United Arab Emirates, Belarus, Russia and elsewhere.
Brazil's drug regulator on Sunday cleared AstraZeneca and Sinovac's shots for emergency use. The Brazilian government aims to launch a national vaccination campaign on Wednesday, though it's still waiting on doses from AstraZeneca to arrive, Reuters reports. The country has locked down 2 million AZ million doses through the Serum Institute of India, which should arrive this week, the country's health minister said Sunday.
Cancer vaccine specialist Gritstone Oncology is developing a vaccine against SARS-CoV-2 that could work against other coronaviruses, too. The vaccine leverages Gritstone’s EDGE technology, which uses machine learning to predict antigens presented by tumor cells or virus-infected cells that the immune system can see. The company has snared a grant from the Gates Foundation for preclinical work, while the NIAID is set to conduct a phase 1 trial. Story
Thermo Fisher is laying out up to $550 million to buy handheld test maker Mesa Biotech. Mesa early last year bagged an emergency nod for its rapid, molecular Accula test at point-of-care for COVID-19. It's also been pegged in the National Institutes of Health's "Shark Tank"-style COVID-19 diagnostics competition, winning federal funding to help scale up its manufacturing lines. Mesa will receive $450 million cash, plus up to $100 million more for future milestones. The deal is expected to close by the end of March. Story
UPDATED: Tuesday, Jan. 19 at 10:00 a.m. ET
Approvals for Johnson & Johnson and AstraZeneca's COVID-19 vaccines are mere "weeks away," the nation's top infectious disease expert, Anthony Fauci, told Meet the Press. J&J has said it's expecting late-stage results on its shot by the end of January. J&J's shot, which is designed to work at a single dose—unlike Pfizer and Moderna's two—could help expedite vaccination efforts in the U.S., health officials figure.
Pfizer and BioNTech are cutting European vaccine deliveries in the next few weeks, thanks to factory modifications—and now Germany's Bayer wants to to fill in the gaps with supplies of CureVac's mRNA shot. "We are ready to pull out all the stops for this," Bayer chief Werner Baumann told German paper Welt am Sonntag. Several EU countries complained Friday that Pfizer and BioNTech would scale back promised deliveries as they work on upgrades at Pfizer's plant in Puurs, Belgium.
State epidemiologist Erica Pan, M.D. urged California to temporarily pause distribution of one Moderna vaccine lot after fewer than 10 patients at a San Diego clinic suffered severe allergic reactions requiring medical attention within a day of being vaccinated. The manufacturer, the CDC and the Food and Drug Administration are investigating.
Governor Andrew Cuomo went straight to the source to ask Pfizer to sell vaccine doses directly to New York State. That move would require approval from the Department of Health and Human Services, the drugmaker replied.
Two people have died after receiving COVID-19 vaccines in India, and local shot maker Bharat Biotech on Monday warned people who are immunocompromised or have "any allergies" to avoid its vaccine. Bharat's shot was recently authorized in "clinical-trial mode," just one day after authorities pressed the company for more efficacy data. An Indian 52-year-old hospital worker died a day after getting AstraZeneca's Covishield shot. Government officials said the man suffered from cardiac arrest, but stressed that his death wasn't related to the vaccine. A second person who was vaccinated Saturday died Monday, though it remains unclear whether he got Bharat's or AZ's vaccine, both of which are authorized in India.
The Subject Expert Committee of India's Central Drugs Standard Control Organisation is weighing whether to OK phase 1 and 2 clinical trials of Bharat Biotech's intranasal vaccine candidate. The adenovirus vectored candidate, BBV154, has so far triggered a protective immune response in mice and hamsters. Earlier this month, Bharat's two-dose intramuscular vaccine was authorized alongside AstraZeneca's shot, produced by Serum Institute of India under the name Covishield, in-country.
Mexico is set to receive 200,000 Pfizer vaccine doses Tuesday before shipments are temporarily paused for the next three weeks. The pause supports a United Nations proposal to limit purchases as vaccine shipments make their way to poorer countries. It shouldn't scupper Mexico's plans to vaccinate its citizens, President Manuel Lopez Obrador said. The country is currently locking in shot deliveries from China's CanSino, Russia and AstraZeneca, he said.
Norway won't change its policy on Pfizer and BioNTech's vaccine after reports of deaths among older, frail patients who'd received the shot. As of Jan. 14, 23 deaths potentially linked to the vaccine had been reported by the Norwegian health registry. “It is important to remember that about 45 people die every day in nursing homes in Norway, so it is not a given that this represents any excess mortality or that there is a causal connection,” Camilla Stoltenberg, director of the Norwegian Institute of Public Health, said.
Serum Institute of India (SII) is homing in on a deal to supply the WHO-Gavi equitable vaccine distribution effort Covax with around 300 million to 400 million more vaccine doses, sources told Rediff. The 400-million-dose supply deal would be separate from a previous agreement SII made to supply 100 million doses each of AstraZeneca and Novavax's shot.
Israel is offering Pfizer weekly updates on its immunization program to help other countries improve their vaccination drives and achieve "herd immunity." Under the deal, the country is providing epidemiological data like the number of confirmed COVID cases, hospitalizations, deaths, the number of patients on ventilators, plus age and other demographic breakdowns. So far, about a quarter of the country's citizens have received their first dose.
UPDATED: Friday, Jan. 15 at 1:51 p.m. ET
The Norwegian Medicines Agency says it's received reports of 23 deaths potentially linked to Pfizer and BioNTech's COVID-19 vaccine Comirnaty. It has so far assessed 13 of the reported cases. Common side effects of the mRNA vaccine like fever and nausea may have contributed to the deaths of certain older, frail patients, the agency's chief physician, Sigurd Hortemo, said in a statement.
A COVID-19 vaccine developed by the Sinopharm subsidiary China National Biotec Group (CNBG) appears safe in children as young as three years, Reuters reported, citing China's state-run press agency, Xinhua. It wasn't immediately clear which of CNBG's two late-stage vaccines was tested in children, though it could be the company's BBIBP-CorV candidate, Reuters surmised, pointing to a previously disclosed phase 2 trial of that shot in children aged three to 17 years old. Story
Researchers at the University of Cambridge developed a DNA test to catch secondary infections, like pneumonia, that may come about during COVID-19 treatment. Patients on mechanical ventilation often receive anti-inflammatory drugs to ease lung damage, but this can leave them more susceptible to bacteria and fungi in the hospital. Developed in collaboration with Public Health England, the test is designed to identify the infection and suggest the proper antibiotic response. It's currently being rolled out to healthcare providers via Cambridge's NHS Foundation Trust. Story
Parexel is joining forces with Signify Health to better understand clinical trial diversity and re-model their studies accordingly. The partnership aims to boost trial access, bring studies into patients' homes and identify social determinants of health to "facilitate connections among local resources, patients, and caregivers,” the pair said in a release. The issue of clinical trial diversity was thrown into sharp relief last year as the COVID-19 pandemic exposed longstanding healthcare inequities. Story
How do you launch a drug during a pandemic? Technology—plus a rolodex full of established contacts, Incyte CEO Hervé Hoppenot told Fierce Pharma. Incyte navigated the launches of two new cancer meds in 2020—Pemazyre and Monjuvi—thanks to its sales reps' existing relationships with cancer centers and doctors, who were willing to jump on Zoom to get the skinny, he said. Things are "quite a bit more challenging" for companies without those connections, Hoppenot admitted. Story
UPDATED: Friday, Jan. 15 at 9:33 a.m. ET
Moderna is offering a third dose of its vaccine to patients who were vaccinated twice in the biotech's phase 1 trial—part of an ongoing study to see whether booster doses are necessary, safe and effective. Moderna is extending the booster to participants six to 12 months after they got their second doses. The company said it may also study a third shot in patients from its late-stage trial, if antibody persistence data warrant it.
President-elect Joe Biden tapped David Kessler, M.D., to take the reins at Operation Warp Speed, The New York Times reports. Kessler was FDA chief during George Bush and Bill Clinton's presidencies and is co-chair of the Biden transition team's pandemic task force. He will split top responsibilities with Gen. Gustave Perna, who will keep his role as Warp Speed's chief operating officer. Kessler will work to speed deliveries of vaccines throughout the country and is also expected to kick off a major antiviral development program, transition officials told NYT.
Meanwhile, President-elect Biden on Thursday asked Congress for about $400 billion in additional pandemic funding to establish a national vaccination program, expand COVID-19 testing and hire on some 100,000 healthcare workers. Biden envisions about $20 billion going toward the addition of an unspecified number of vaccination sites, including mobile ones. He wants to plug another $50 billion into expanded testing efforts, as well as hire on a suite of public health staffers and boost efforts to track emerging virus variants, too.
When India launches its mass vaccination campaign Saturday, the government will approach AstraZeneca and Bharat Biotech's shots "equally," and people won't have a say in which vaccine they get, Vinod Paul, who heads a government panel on vaccine strategy, told Reuters. Bharat's shot Covaxin was recently authorized in "clinical-trial mode," just one day after authorities pressed the company for more efficacy data. Many health experts have since challenged Covaxin's go-ahead. Meanwhile, late-stage data on the vaccine are expected in March.
Speaking of AstraZeneca, the Serum Institute of India (SII) expects WHO to issue an emergency nod for the British drugmaker's shot "in the next week or two," SII chief Adar Poonawalla said at the Reuters Next conference. SII hopes to start supplying shots to the agency's equitable vaccine distribution effort, Covax, by the end of January, he said. WHO late last year listed Pfizer and BioNTech's mRNA shot for emergency use in a bid to hasten vaccination efforts in the developing world.
UPDATED: Thursday, Jan. 14 at 3:25 p.m. ET
Moderna linked up with Uber to boost shot confidence and make it easier for people to get vaccinated, too. It's still early-stage stuff, but initial ideas include promoting vaccine safety through in-app messages on the Uber network, as well as folding rides into the vaccine scheduling process. The goal is to provide widespread access and improve outreach to underserved populations and people who are vaccine-hesitant, Michael Mullette, Moderna’s VP of commercial operations in North America, said. Story
A slate of tech companies and health organizations—including Microsoft, Oracle, Salesforce, Cerner and the Mayo Clinic—have partnered on the Vaccination Credential Initiative, aiming to establish a standard for digital vaccination records. The goal is to eventually provide people with an “encrypted digital copy of their immunization credentials” on their smartphones, or a printed QR code for people without a device.
As certain hospital and nursing home staffers refuse vaccines, employers are adopting unusual measures to sweeten the offer—like cash, extra time off and Waffle House gift cards—or threatening to fire their workers altogether, The New York Times reports. Long-term care chains Juniper Communities and Atria Senior Living are making the shot non-negotiable if employees want to keep their jobs, for instance. Meanwhile, critics told NYT it’s unethical to pressure low-paid workers into getting the vaccine.
Florida’s so-called “vaccine tourism,” is taking heat, The Wall Street Journal reports. The state has made the vaccine available to anyone age 65 and older, including nonresidents, drumming up interest from people in places like Canada and Latin America eager to fly over for a quick shot. The move has frustrated academic experts, politicians and residents across the Sunshine State. Meanwhile, Gov. Ron DeSantis said he wasn’t opposed to giving the shot to those who live in Florida part-time, but added that the state’s “discouraging people to come to Florida just to get a vaccine.”
The wildly divergent efficacy figures for Sinovac's shot, CoronaVac—which Brazilian scientists most recently pegged at a little over 50%—could put China’s plans for global health diplomacy at risk, the NYT reports. Countries that bought the shot may question its efficacy, which could lead to political fallout in places like Brazil, where the prospect of importing CoronaVac has already been fraught. Meanwhile, the piecemeal release of data "just reinforced the narrative that this vaccine is not good," Brazilian-American epidemiologist Denise Garrett told NYT.
Twitter on Thursday briefly restricted the official account of Russia's Sputnik V vaccine, prompting the Russian Direct Investment Fund to put out a call to action for its followers to demand restored access. Turns out, that wasn't necessary. “This account was temporarily locked in error by an automated spam filter. This action has been reversed and the account is now fully operational,” Twitter said in a statement. The temporary shutdown may be tied to “a possible security breach from Virginia, USA," the Sputnik V account said.
UPDATED: Thursday, Jan. 14 at 9:45 a.m. ET
Johnson & Johnson's single dose COVID-19 vaccine seems to trigger a safe and effective immune response in people young and old, phase 1/2 data published in the New England Journal of Medicine showed. Ninety percent of volunteers developed neutralizing antibodies by day 29, while all volunteers had detectable antibodies by day 57. Plus, patients' immune responses lasted all 71 days of the trial. Fever, headache, fatigue, muscle aches and injection site pain comprised the most common side effects.
Initial Johnson & Johnson vaccine shipments could arrive in Europe by April 1, a European Union official told Reuters. The European Medicines Agency has been conducting a rolling review of J&J's shot since the start of December. Earlier Wednesday, EU lawmaker Peter Liese told the news outlet that J&J would submit an application for approval in February, citing Health Commissioner Stella Kyriakides.
Alexion is halting enrollment of its phase 3 Ultomiris trial in severe COVID-19 patients requiring mechanical ventilation. The move comes on the heels of an independent data analysis, which found Ultomiris plus best supportive care didn't meaningfully boost survival at day 29 versus supportive care alone. The study will continue for patients already enrolled, Alexion said. Story
The industry can expect COVID-19 work to be "recurring and long-lasting," Operation Warp Speed chief Moncef Slaoui said Wednesday at the J.P. Morgan Healthcare Conference. While the general public may be holding out hope that the pandemic will simply disappear, "we cannot forget," Slaoui warned. "We forgot with Ebola. We forgot with Zika."
Scientists at The Ohio State University Wexner Medical Center and College of Medicine have ID'd a new variant of the coronavirus that bears a mutation identical to the variant from the U.K.—though it likely cropped up in a version of the virus already present in the U.S., they said. Meanwhile, the researchers reported another U.S. variant with three gene mutations not previously seen together in SARS-CoV2. At this point, researchers say they have no evidence to suggest the new variants might affect vaccine efficacy.
President-elect Joe Biden on Wednesday evening is expected to blueprint plans for trillions of dollars of government spending to tackle COVID-19 and its effects on the economy. Part of that package will fuel vaccine development, testing and contact tracing efforts, Brian Deese, the soon-to-be director of the National Economic Council, said Wednesday at the Reuters Next conference.
UPDATED: Wednesday, Jan. 13 at 3:30 p.m. ET
Under its $1 billion Operation Warp Speed (OWS) contract, Johnson & Johnson was originally set to provide 12 million vaccine doses by the end of February and 100 million by the end of June, but federal officials have now been informed the company is behind on its production timeline, sources told The New York Times. OWS chief Moncef Slaoui last week said the company would be able to deliver doses in the "single-digit" millions by February's end as J&J works to boost those numbers over the following months, the NYT reports. Story
Sinovac's vaccine was just 50.38% effective in a Brazilian phase 3, the Butantan Institute—which ran the trial—and the government of Sao Paulo said Tuesday. That's well below the 78% success rate Butantan reported last week, which it has now linked to efficacy against mild COVID cases. Meanwhile, it reported the shot was 100% effective against moderate and severe cases, but just 50.38% effective overall. Elsewhere, early phase 3 data from Indonesia placed efficacy at 65.3%, while Turkey said the shot was 91.25% effective.
Armed with an educational grant from the Johnson & Johnson Institute, medical education video game developer Level Ex has created new pandemic-specific levels for its Airway Ex, Pulm Ex and Cardio Ex mobile games. Similar to a flight simulator for pilots, Level Ex's games place players in a digital emergency room, facing patients who may or may not be infected with COVID-19. Players must determine whether the virtual patient is infected and, if so, decide how to safely deal with them to minimize spread. Story
Researchers from the University of Bonn, the Karolinska Institute and Scripps Research Institute designed a COVID-19 drug based on "nanobodies," the tiny antibodies produced by camelids. By fusing two nanobodies picked from a llama and an alpaca immunized with the virus, the researchers synthesized nanobodies able to simultaneously attack multiple sites of the virus’s spike protein and fight mutated variants, too, a study published in Science showed. A University of Bonn spinoff, Disclosure Therapeutics, plans to push two lead candidates into the clinic this year. Story
Celltrion's experimental antibody helped mild-to-moderate COVID-19 patients in a phase 2/3 trial. The 40 mg/kg dose—the lower of two Celltrion is testing—reduced progression to severe disease by 54% versus placebo at day 28, while reduction was 68% in a subgroup of moderate COVID patients aged 50 years and older. Patients on the low dose recovered in 5.4 days, compared to 8.8 days in the control group, with the difference even larger in certain subgroups. Meanwhile, viral load fell significantly versus placebo at Day 7. Story
Pfizer and BioNTech were able to raise their projected 2021 vaccine output to 2 billion doses thanks to some "very out of the box" manufacturing," Pfizer chief Albert Bourla said Tuesday. The company has launched a slate of initiatives, including changing the way it works with partners on raw materials, reimagining its operational flow to boost capacity, designing new equipment and more, he said. Story
Don't discount CureVac's role as a major vaccine player just yet, Marianne De Backer, head of business development at Bayer—which recently penned a vaccine pact with CureVac—said Wednesday at the J.P. Morgan Healthcare Conference. "[We] will need between 12 (billion) and 14 billion doses to get a full handle on the pandemic,” she said, suggesting every company in the vaccine race should "continue to put all the effort in to curb this pandemic.” Story
It's still too early to say when AstraZeneca might turn a profit on its vaccine, Ruud Dobber, EVP and biopharma president at the company, said in a Fierce JPM Week interview. “Let’s first deliver all the doses, let’s make sure people are getting vaccinated, and then we will decide at a certain stage when we are going to commercialize the vaccine,” he said. AZ has said it won't profit off the vaccine during the pandemic, though a report emerged in October that the drugmaker might be ready to declare the pandemic over as soon as July. Story
UPDATED: Wednesday, Jan. 13 at 9:20 a.m. ET
The U.S. agreed to buy all doses of Regeneron's antibody cocktail delivered by June 30, amounting to upward of 1.25 million, the company said. The deal brings the government's total potential order to over 1.5 million doses. Uptake of the treatment has been underwhelming, George Yancopoulos, M.D., Ph.D., Regeneron's R&D chief, said at this week's J.P. Morgan healthcare conference—a problem the company said it could remedy by working more closely with the U.S. government.
Operation Warp Speed chief Moncef Slaoui has resigned at the request of President-elect Joe Biden's transition team. Slaoui will stick around for the next 30 days to ease the switch, two people close to the matter told CNBC. His role will likely be diminished once Biden takes office on Jan. 20, the sources added.
Pfizer is working with BioNTech to ratchet up its 2021 vaccine production goal to 2 billion doses, CEO Albert Bourla, Ph.D., reiterated Tuesday. Pfizer will also implement a label change to include six doses in each vial instead of five—plus, it's rolling out a new syringe that reduces the chances of liquid becoming stuck in the needle.
Some Australian scientists think the country should delay its immunization drive with AstraZeneca's vaccine, citing potential efficacy issues, Reuters reports. “The question is really whether [AstraZeneca's vaccine] is able to provide herd immunity," Stephen Turner, president of the Australian and New Zealand Society for Immunology, told the news service. AZ's shot boasted 62% efficacy in phase 3, well below the 90%-plus success rates of Pfizer and Moderna's vaccines.
Despite those calls, Australia's CSL remains committed to production of the 50 million AstraZeneca doses it agreed to churn out last year—even as investors call for CSL to break into the mRNA space, The Sydney Morning Herald reports. A CSL spokeswoman told the news outlet that the first locally produced doses would be available in the second quarter of the year, subject to regulatory approval. The company said it could look to mRNA in the future but likely couldn't produce mRNA vaccines in time for this pandemic.
China's Sinovac could double annual capacity for its pandemic shot, CoronaVac, to 1 billion doses as early as next month, the group's chairman, Yin Weidong, said Wednesday. Sinovac's existing production line boasts capacity for 500 million doses per year, while another line with the same capacity could come online by February, Yin said.
UPDATED: Tuesday, Jan. 12 at 3:13 p.m. ET
Some COVID-19-related documents and data breached in a December cyberattack on the European Medicines Agency (EMA) have surfaced online, the regulator said Tuesday. The EMA didn’t disclose which documents or data were leaked, adding that law enforcement was on the case. Pfizer and BioNTech in December said documents related to their COVID-19 vaccine, Comirnaty, had been accessed in the attack.
French shot developer Valneva is in “advanced” talks with the European Commission to supply Europe with up to 60 million doses of its inactivated vaccine candidate, the company said. The shot entered phase 1/2 studies in December, with initial safety and immunogenicity data expected in April, Valneva said. Meanwhile, the company in September agreed to supply the U.K. with up to 190 million doses.
A new coronavirus variant, similar to those identified in South Africa and the U.K., has cropped up in Japan, the country's National Institute of Infectious Diseases (NIID) said. The variant was found in four passengers traveling from Brazil, one of whom was asymptomatic upon arrival before he was later hospitalized, Japan's Ministry of Health added. The NIID has alerted the World Health Organization and said it is investigating whether the variant could trigger more severe disease.
Uptake of Regeneron's antibody cocktail needs to improve, R&D chief George Yancopoulos, M.D., Ph.D., said Monday at the annual J.P. Morgan healthcare conference. To overcome potential treatment barriers—Regeneron's cocktail requires a prescription and must be infused—the company plans to work "much more closely" with the government to effectively deliver its cocktail to patients, he said. Plus, the therapy should stand up against emerging virus variants, since "it reduces the likelihood that a single variant can become resistant to both antibodies in the cocktail," CEO Len Schleifer, M.D., Ph.D., said. Story
For many drugmakers, changes made during the pandemic are here to stay. Eli Lilly, for instance, plans to continue leveraging virtual trials that feature remote patient monitoring and digital interactions with trial sites, CEO David Ricks said Tuesday. Meanwhile, the advent of remote work has inspired Moderna to weigh how it leverages talent regardless of geography, the company's chief, Stéphane Bancel, said. Story
The first wave of COVID-19 vaccines wont be enough to quell the pandemic, Swati Gupta, Ph.D., an executive with IAVI, said on a Fierce JPM Week panel. While those early launches will help end the "acute" phase of the pandemic, COVID-19 will likely become endemic, so “we also need to plan for longer-term management of the disease.” Others, like Valneva CEO Thomas Lingelbach, are confident there will be demand for follow-up vaccines. Those shots could offer efficacy at a single dose, prove easier to scale up or be better-suited to refrigerated storage, Gupta added. Story
UPDATED: Tuesday, Jan. 12 at 1:12 p.m. ET
The Trump administration is switching up its vaccine rollout, Axios first reported. First, the administration aims to promptly release the majority of shots on tap, rather than holding them back for second doses, Department of Health and Human Services Secretary Alex Azar told ABC's "Good Morning America." It's also calling on states to give the vaccine to everyone 65 and older, plus those with underlying health conditions, he said. President-elect Joe Biden last week said he wanted to release most available doses to get them out to the public faster. Meanwhile, Azar is set to share further details at a midday press conference.
UPDATED: Tuesday, Jan. 12 at 11:26 a.m. ET
GlaxoSmithKline and Vir Biotechnology will run a National Health Service-backed trial assessing Vir's antibody hopeful, VIR-7832, in early COVID-19. The so-called Agile trial is due to kick off in the first quarter of 2021 and will take place at multiple sites in the U.K., the companies said. Meanwhile, the partners have another Vir antibody, VIR-7831, currently in two phase 3 studies. The new trial comes as experts are emphasizing the need for additional COVID-19 therapeutics.
AstraZeneca's vaccine is up for review this month in Europe, the European Medicines Agency said. The regulator on Tuesday said it received an application from AstraZeneca and could make an authorization decision as early as Jan. 29. The EU has locked in an order for up to 400 million AstraZeneca doses and expects to receive initial deliveries two weeks after authorization.
Los Angeles County is pulling Curative's oral swab COVID-19 test from its mobile testing sites after the FDA warned that the startup's diagnostic carries a risk of false results—and in particular, false negatives, local outlet KTLA reports. Asymptomatic patients are especially likely to receive incorrect results, the FDA added. Curative tests at 14 sites operated by the city will remain unaffected by the county's decision.
Japan's Chugai Pharmaceutical saw its shares surge Tuesday on the heels of a U.K.-funded study showing rheumatoid arthritis meds Kevzara and Actemra could reduce the risk of death and hustle COVID-19 patients out of intensive care units faster. Chugai co-developed Actemra, also known as tocilizumab, with Roche, while Sanofi and Regeneron are working together on Kevzara, also known as sarilumab.
Elsewhere in L.A., officials are converting Dodger Stadium from a testing site to a vaccination center, hoping to eventually immunize 12,000 people a day, the Los Angeles Times reports. Until Monday, Dodger Stadium was the largest testing site in the U.S. and had administered more than 1 million tests since May.
The Biomedical Advanced Research and Development Authority folded Albany Molecular Research's (AMRI's) Albuquerque, New Mexico, facility into its CDMO network. AMRI's Albuquerque site houses a large fill-finish facility that is already supporting COVID-19 vaccine production, the company said.
UPDATED: Monday, Jan. 11 at 3:05 p.m. ET
Novavax tapped contract manufacturer Baxter BioPharma Solutions to support commercial-scale production of its vaccine hopeful, NVX-CoV2373, at the CMO's facility in Halle, Germany. The move is intended to boost availability of the shot, still in phase-3 studies, across Europe and the U.K., the partners said in a release.
Moderna is kicking off deliveries of its mRNA vaccine to European Union and European Economic Area member states on Monday, a spokesperson told Fierce Pharma. All shipments will be handled by the Switzerland-based transport and logistics firm Kuehne+Nagel through its centralized pharma hub in Europe.
Merck KGaA snapped up German mRNA manufacturer AmpTec to bolster development and production for customers using the platform to make diagnostics, therapeutics and vaccines, including those for COVID-19. With mRNA technology on the rise, Merck says it's plotting related scale-ups at AmpTec's existing site in Hamburg, Germany, plus its own home base in Darmstadt. Story
As the scramble to repurpose drugs against COVID-19 tapers off, "I think what we’re seeing is the emergence of real customized drugs that are highly focused on SARS-CoV-2,” Ann Leen, Ph.D, chief scientist at AlloVir—developing off-the-shelf T-cell therapies to combat viruses—said during a Fierce JPM Week panel. As experts' understanding of COVID-19 evolves, it's clear there won't be a "silver bullet," Wendy Holman, CEO of Ridgeback Biotherapeutics, said. “It’s important to have multiple shots on goal and potentially, combination therapy.” Story
Select Publix pharmacies in Florida will start deploying COVID-19 vaccines, Gov. Ron DeSantis said—and all available appointments have already been booked, local outlet ClickOrlando reports. Each site plans to vaccinate around 120 people per day, the supermarket chain said. Publix is also supporting vaccination drives in Georgia, Alabama, Tennessee, South Carolina, North Carolina and Virginia.
President-elect Joe Biden got his second dose of Pfizer's vaccine on camera Monday. This marks Biden's second televised vaccination—part of a bid to boost confidence in the shot. Vice President-elect Kamala Harris was also taped when she received her first dose of Moderna's shot in December, one week after Biden's initial injection. Biden has pledged to roll out 100 million COVID-19 shots during his first hundred days in office and recently suggested the U.S. release nearly all doses on hand to hasten distribution efforts.
Synairgen's inhaled form of interferon beta-1a raised levels of a short form of ACE2 that doesn't allow the COVID-19 virus to enter cells and may also have a protective effect, researchers at the University of Southampton found. Last summer, Synairgen showed that its interferon drug lowered risk of progression to severe COVID-19 in a 101-subject trial, but there was a caveat: Interferon is known to increase levels of the cell surface protein ACE2, which serves as the entry point for the virus that causes COVID-19. Story
NeuroRx and Relief Therapeutics' coronavirus treatment hopeful Zyesami has been pegged for inclusion in the I-SPY COVID-19 Trial. Sponsored by San Francisco's Quantum Leap, the I-SPY platform study is assessing multiple drugs in patients hospitalized with severe COVID-19. Zyasemi is also being studied in two U.S. phase 2b/3 trials in COVID-19 respiratory deficiency, both as an inhaled and intravenous option.
Russia wants to expedite its immunization program by potentially halving the two-dose regimen of its Sputnik V vaccine, The New York Times reports. While Russia's shot currently leverages two types of genetically modified human adenoviruses, the single-dose approach would see only one type of the cold virus administered in each shot, Sputnik V's developer, the Gamaleya Institute, said.
UPDATED: Monday, Jan. 11 at 9:27 a.m. ET
Fujifilm Diosynth and Texas A&M's Center for Innovation in Advanced Development & Manufacturing (CIADM) kicked off production of two vaccine candidates at CIADM's Flexible Biomanufacturing Facility in College Station, Texas. Fujifilm has been tapped to crank out bulk drug substance for Novavax's candidate, NVX‑CoV2373, which kicked off phase 3 testing the U.S. and Mexico in December. The company is also manufacturing the shot at commercial scale at its Morrisville, North Carolina, plant.
BioNTech ratcheted up its vaccine production forecast at this year's virtual J.P. Morgan healthcare conference. The company now has its sights set on 2 billion doses by year-end, up from an original 1.3 billion-dose goal. Meanwhile, it's looking to boost supply capacity by introducing a new six-dose vial, alongside plans to establish new sites, suppliers and CMO pacts.
It's time for the U.S. to "hit the reset" on its vaccine rollout strategy, ex-FDA chief Scott Gottlieb, M.D., told CBS News' "Face the Nation" Sunday. With some 40 million doses available, the government should adopt an "all-of-the-above approach" to push shots out through different channels like "big-box stores" and the federal sites President-elect Joe Biden has talked about setting up. So far, only about 6.7 million Americans have received the first of two necessary doses, according to the CDC.
Meanwhile, front-line healthcare workers at greater Manchester hospitals in the U.K. will have to wait 11 weeks before they can get their second dose of Pfizer and BioNTech's vaccine, Manchester Evening News reports. The British government last month unveiled plans to delay patients' second shots as the country prioritizes delivery of initial doses. Pfizer itself has cautioned against the move, warning that available data do not support a longer lag time between doses. The recommended schedule is 21 days after the first dose.
Gregory Michael, a 56-year-old doctor from South Florida, died two weeks after taking Pfizer and BioNTech's COVID-19 vaccine. A CDC spokesman confirmed to local news outlet South Florida Sun Sentinel that it's investigating one death where a vaccine may be involved, but didn't confirm whether it was specifically reviewing Michael's case. Pfizer is running its own investigation, though it doesn't believe there is any direct connection between the death and its vaccine, a spokesperson told the Sun Sentinel.
The Indian government is in talks with the Serum Institute of India (SII) to lower the price of AstraZeneca's vaccine, sources close to the matter told The Economic Times. While the country's drug regulator has authorized shots from AZ and local developer Bharat Biotech, it hasn't locked down firm orders with either company, ET wrote. SII chief Adar Poonawalla in November said the shot would cost around ₹1,000 ($13.55) per dose on the private market in India and around ₹250 ($3.40) per dose for the government.
Pfizer and BioNTech's vaccine will only be available in "major cities" in the Philippines, thanks to a lack of cold chain capability in the country, a presidential spokesperson said. The country recently locked in an order for 30 million doses of Novavax's vaccine through the Serum Institute of India, the spokesperson added. Plus, the country is in talks with Moderna, AstraZeneca, Johnson & Johnson, Sinovac and Russia's Gamaleya Institute.
UPDATED: Friday, Jan. 8 at 3:10 p.m. ET
With the U.S.' shot rollout lagging, President-elect Joe Biden wants to release nearly all available vaccine doses, his transition team said Friday. “[Biden] supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now," a spokesman for the transition team said. One potential hurdle? Releasing those doses all at once could make it harder for people to receive their second shot on time. Both Moderna and Pfizer's vaccines call for two doses at specific intervals.
Labcorp is teaming up with the CDC to conduct a large-scale genomic study tracking new mutations in the coronavirus. The agency plans to collect random samples from around the U.S., providing a baseline that should allow national and state-level surveillance programs to catch emerging cases. With Labcorp's facilities on deck, the CDC says it aims to more than double the number of genomic samples sequenced per week. Story
Moderna named industry vet Corinne Le Goff chief commercial officer as the drugmaker embarks on its first-ever product launch—which just so happens to be the second COVID-19 vaccine to market in the U.S. Le Goff joins from Amgen, where she was most recently senior VP and president of the company's U.S. business. Aside from its pandemic shot launch, Moderna is gearing up for a phase 3 study of its mRNA-based cytomegalovirus vaccine. Story
Pfizer has agreed to boost vaccine deliveries to Israel in exchange for data on the country's immunization program, Prime Minister Benjamin Netanyahu said Thursday. More than 1.7 million Israelis have already received their first dose, and the country has sketched out the goal to be able to vaccinate all citizens over the age of 16 by the end of March. While Israel's second Pfizer shipment was originally scheduled to arrive in February, that delivery is now expected Sunday. Plus, Pfizer has agreed to provide the country with millions more doses, Netanyahu said.
It's fine if priority vaccination groups overlap, the CDC said Friday, clarifying guidance that many states have already implemented as they hustle to get shots out to the public. Healthcare workers and nursing home residents should be first in line, followed by essential workers and people over the age of 75, the agency has said. The CDC's website is now updated to show that the various priority groups—1A, 1B and 1C—could intersect.
Meanwhile, healthcare providers in the U.K., plus some parts of Florida, Tennessee and Texas, are using the online ticketing service Eventbrite to schedule vaccine appointments, The New York Times reports. It's far from a perfect system, though: Scams for bogus vaccination slots have already been reported in Florida, while some have cited the need for a computer and a speedy internet connection to book an appointment as a potential barrier to access.
UPDATED: Friday, Jan. 8 at 9:17 p.m. ET
The European Commission floated a deal to snag an extra 200 million doses of Pfizer and BioNTech's vaccine, with the option to later purchase 100 million more. Building on a previous deal for up to 300 million doses of the partners' shot, the expanded order would allow the bloc access to some 600 million doses. Deliveries of the newly secured product would begin in the year's second quarter, the commission said.
The U.K. authorized Moderna's mRNA vaccine Friday, adding a third shot to its pandemic arsenal. The country also locked down an additional 10 million Moderna doses, bringing its total order to 17 million. Deliveries are pegged to begin in the spring. So far, roughly 1.5 million people in Britain have received at least one shot, Bloomberg reports.
Pfizer and BioNTech's vaccine seems to work against a key mutation in variants of the novel coronavirus found in South Africa and the U.K., a lab study showed. Blood collected from 20 patients who received the shot in Pfizer's phase 3 successfully neutralized the so-called N501Y mutation, located in the receptor binding site of the spike protein. The partners have now shown their vaccine works against 16 different mutations of the virus. Story
The World Health Organization (WHO) is reviewing shots from AstraZeneca and China for a possible emergency listing, Kate O'Brien, the agency's immunization director, said Thursday. The WHO is also "in discussions and beginning processes with other vaccines," she added. The agency on Dec. 31 listed Pfizer and BioNTech's vaccine for emergency use.
Australia inked a deal for 51 million doses of Novavax's late-stage vaccine, with the option to buy up to 10 million more doses, the company said Thursday. Shipments are expected to kick off in mid-2021. Novavax launched a U.S. phase 3 study in December after weathering multiple manufacturing delays.
South Africa is in "advanced" talks with Johnson & Johnson to lock down vaccine supplies, the country's health ministry said Thursday. Local manufacturer Aspen Pharmacare aims to kick off production of J&J's shot in late March or early April, but those Aspen doses are earmarked for export. The country is set to receive 1.5 million doses through the Serum Institute of India this month and next, which it will use to vaccinate healthcare workers.
Turkish drugmaker Abdi Ibrahim got the OK from the country's health ministry to manufacture and fill vials of inactivated vaccines, plus mRNA vaccines, against COVID-19, state-run news outlet Anadolu Agency reported. The company has capacity for 20 million doses, Nezih Barut, chairman of Abdi Ibrahim, told Anadolu.
UPDATED: Thursday, Jan. 7 at 3:10 p.m. ET
mRNA specialist CureVac tapped German compatriot Bayer to support clinical development, manufacturing, regulatory affairs and marketing on its late-stage vaccine hopeful, CVnCOV. With their forces combined, the partners aim to crank out "hundreds of millions" of doses once the shot is approved. No financial details were given. CureVac will be on deck in the EU and a few other markets, while Bayer holds options to be the rights owner in most ex-U.S. territories. Story
Roche's Actemra (tocilizumab) and Sanofi's Kevzara (sarilumab) reduced death rates by 8.5% in patients hospitalized with severe COVID-19, a British study showed. The REMAP-CAP trial, still awaiting peer review, enrolled some 800 subjects. Patients receiving either Kevzara or Actemra had a mortality rate of 27.3%, compared to 35.8% in the control arm. On average, patients treated with the rheumatoid arthritis meds were also discharged from intensive care units around seven to 10 days earlier than those in the control group. The U.K. plans to start using the drugs immediately. Story
South Africa's Aspen Pharmacare could start producing doses of Johnson & Johnson's vaccine in late March or early April, if approvals are in place, Stavros Nicolaou, group senior executive for strategic trade at Aspen, told Reuters. The company is waiting on a technology transfer and currently has capacity for up to 300 million doses. All shots produced by Aspen will be exported and folded into J&J's global supply, Nicolaou said.
Peru locked in the delivery of 1 million Sinopharm vaccine doses this month—part of a larger deal for 38 million doses from the Chinese firm, President Francisco Sagasti said Wednesday. Peru has also closed a deal for 14 million AstraZeneca doses, though shipments aren't expected to begin until September, Sagasti said.
Sinovac's shot CoronaVac proved 78% effective in phase 3, Brazil's Butantan Institute said. Among more than 12,000 healthcare workers enrolled in the trial, no one developed severe cases of COVID-19, the São Paulo-based research center said. Turkey unveiled interim phase 3 data in December showing the vaccine was 91.5% effective. Indonesia is also running a late-stage study of the vaccine but has yet to issue results. Story
William Hanage, Ph.D., associate professor of epidemiology at the Harvard T.H. Chan School of Public Health, is trying to break down two coronavirus variants at the top of everyone's mind:
Some brief comments from me about the variantshttps://t.co/X5YsFSTGIZ— Bill Hanage (@BillHanage) January 7, 2021
As millions of COVID-19 vaccines start rolling out, drugmakers of all kinds should brace for a wave of side effect reports and lawsuits. "Unprecedented" development timelines, emergency use authorizations and media scrutiny will likely drive high incidences of vaccine side effect reports, Torrey Cope, a partner at law firm Sidley Austin, told Fierce Pharma. Meanwhile, vulnerable people set to receive the first vaccines are likely on multiple medications, and companies who make those drugs can expect new reports, too, another partner at the firm said. Story
UPDATED: Thursday, Jan. 7 at 9:12 a.m. ET
Moderna's mRNA shot could provide years of protection against COVID-19, though more data are needed to support that claim, CEO Stéphane Bancel said. Concerns from early last year that a shot might only work for a few months are "out of the window," he said. “The antibody decay generated by the vaccine in humans goes down very slowly … We believe there will be protection potentially for a couple of years.”
Johnson & Johnson's single-dose vaccine could snare U.K. approval within weeks, local scientists and government officials told The Telegraph. Britain has purchased 30 million doses of the vaccine, developed by J&J's Janssen unit, with the option to purchase another 22 million doses. Meanwhile, U.K. Vaccine Taskforce adviser Sir John Bell said he was hopeful J&J supplies could reach the country in time for British vaccination rates to pick up by mid-February.
States need to intensify their vaccine rollouts, and any extra supplies should be used to swiftly vaccinate the elderly or people with underlying health conditions, Department of Health and Human Services Secretary Alex Azar said at a media briefing Tuesday. "We cannot let perfection be the enemy of good," he said. "Prioritized recommendations are simply recommendations, they should never stand in the way of getting shots in the arms."
Meanwhile, the U.K.'s vaccine rollout is lagging, thanks to limited supply. Now, the government is working with both Pfizer and AstraZeneca to ramp up deliveries, health minister Matt Hancock said. “The manufacturers are doing a brilliant job, and they’re delivering to the schedule that’s agreed, but that schedule is the amount of vaccine that we have … [We] expect to see that amount of vaccine being delivered going up.”
India's Bharat Biotech has recruited 25,800 volunteers for its late-stage vaccine trial, the company said Thursday. Bharat's shot, dubbed Covaxin, bagged an emergency use authorization in India Sunday, just seven weeks after starting a phase 3 study. Krishna Ella, chairman of Bharat, recently defended the company's approval, pointing to a government notification from 2019 that says "good quality immunogenicity data" from phase 1 and 2 trials can be used to win an emergency license.
UPDATED: Wednesday, Jan. 6 at 3:06 p.m. ET
AstraZeneca's vaccine now boasts emergency nods in India, Argentina, Mexico, the Dominican Republic, El Salvador and Morocco, the British pharma said Wednesday. The shot's approval in India, where AZ has teamed up with Serum Institute of India to crank out 1 billion doses for low- and middle-income nations, is an important step toward delivering the vaccine to millions of people worldwide, AZ chief Pascal Soriot said.
Meanwhile, India's drug regulator has blocked Serum Institute of India (SSI) from exporting doses of the AstraZeneca shot for several months as the country prioritizes vaccinating its own vulnerable populations first, company CEO Adar Poonawalla told the Associated Press. Exports to the WHO's Covax distribution initiative won't start until March or April, though SII is working to sign a larger agreement with Covax for 300 million to 400 million doses, he said. SII has so far pledged 200 million doses to the distribution effort, split between AZ and Novavax's shots.
New York will start fining hospitals that fail to dispense their allocated vaccine doses within a week of receiving supplies, Gov. Andrew Cuomo said Monday. What's more, the state will also bar those hospitals from receiving future doses. Florida, meanwhile, is allocating doses to hospitals that dispense them quickest, while sites that fail to push the vaccine out fast enough will have their supplies shipped to hastier locations, Gov. Ron DeSantis said.
The U.S. could soon administer at least 1 million COVID-19 vaccines per day, NIAID director Anthony Fauci told the Associated Press. After a slow start, U.S. vaccination efforts are ramping up, reaching some half a million shots a day, he said, adding that President-elect Joe Biden's bid to hit 100 million vaccinations during his first hundred days in office was an achievable goal. “Any time you start a big program, there’s always glitches. I think the glitches have been worked out,” Fauci said.
The University of California, San Diego, is using sidewalk vending machines to dispense self-administered COVID-19 tests to students and staff, the La Jolla Light reports. After a nose swab is performed, samples are sealed and returned to drop boxes around campus for analysis by the university’s own EXCITE laboratory. Results are typically returned within 12 to 24 hours. The school currently requires all students on campus to be tested weekly, regardless of symptoms. Story
Color, which bagged a slate of FDA emergency nods for COVID-19 testing and self-sampling kits last year, raised $167 million in a series D funding round as it looks to scale up and expand into digital vaccine logistics. Color's software platform is used to manage California's COVID-19 testing efforts, and the company also works with diagnostics maker PerkinElmer to process up to 150,000 samples per day. Looking ahead, Color aims to launch vaccine delivery systems through its established testing networks. Story
UPDATED: Wednesday, Jan. 6 at 9:38 a.m. ET
A South African variant of the novel coronavirus appears to "obviate" certain countermeasures like antibody drugs, former FDA Commissioner Scott Gottlieb, M.D., told CNBC. The variant, which has cropped up in South Africa and Brazil, seems to partially escape prior immunity, which could make recovered patients' own antibodies and currently approved antibody therapies less effective, Gottlieb warned. “Now, the vaccine can become a backstop against these variants really getting more of a foothold here in the United States, but we need to quicken the pace of vaccination," he said.
The European Medicines Agency gave Moderna's vaccine a thumbs-up, recommending its authorization for people ages 18 and older. The agency's human medicines committee (CHMP) based its recommendation on phase 3 data showing Moderna's shot was 94.1% effective. Once the European Commission rubber-stamps the EMA's approval, Moderna's vaccine will join Pfizer and BioNTech's as the second authorized in the EU.
Moderna and the National Institutes of Health are determining whether supplies of the company's vaccine could be doubled by halving the dose, The New York Times reports. Warp Speed chief Moncef Slaoui, M.D., on Monday said people who received two 50-mcg doses of Moderna's shot, compared to the standard 100-mcg regimen, showed an "identical immune response," referring to data from an early phase 2 study. To change the dosing, Moderna will need to look back at its phase 2 or run a new study.
The U.K. should administer second doses of Pfizer and BioNTech's vaccine within 21 to 28 days or, in exceptional circumstances, within six weeks, the World Health Organization (WHO) said Tuesday. The U.K.'s Joint Committee on Vaccination and Immunisation had recommended patients get their second shot within three to 12 weeks to stretch initial supplies. "[It] is important to note that there is very little data from the trials that underpin this type of recommendation," one WHO expert said.
Some 3.5 million AstraZeneca vaccine doses are awaiting approval from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), Sky News reports. So far, only 530,000 AZ doses out of an initial order for 4 million have been cleared for use through batch testing. The MHRA is working in parallel with AstraZeneca's own batch-testing process to speed up deliveries.
India's authorization of Bharat Biotech's vaccine is taking more heat. The Indian drug regulator's subject expert committee actually requested more efficacy data just one day before apparently reversing its stance to issue an OK, documents show. Bharat's vaccine, Covaxin, is still in phase 3 testing and was approved "in clinical trial mode"—unconventional language that's left some experts perplexed.
U.S. Rep. Kevin Brady, R-Texas, said Tuesday that he'd tested positive for COVID-19 after receiving an initial dose of Pfizer's vaccine. “As recommended, I received a first dose of the Pfizer vaccine Dec 18 & also recently tested negative for Covid on New Years Day. Begin treatment tomorrow," Brady tweeted.
On Sunday, the Transportation Security Administration said 1.3 million Americans passed through airport security—the highest daily tally of travelers since the pandemic began, the Center for Infectious Disease Research and Policy reports. Many states are now bracing for a surge of new infections in the wake of the holidays. Hard-hit Southern California has told paramedics to conserve oxygen and not to bring patients with little hope of survival to hospitals. Meanwhile, COVID-19 patients now occupy 1 in 5 hospital beds in Texas—a record for the state, the Texas Tribune reported.
UPDATED: Tuesday, Jan. 5 at 3:07 p.m. ET
The European Medicines Agency is due to decide on Moderna's mRNA vaccine Wednesday. The agency's human medicines committee (CHMP) met Monday to discuss the shot but said it would need to meet again on Wednesday. The EMA will also hold a public meeting Jan. 8 to outline its assessment, approval and vaccine rollout plans for European Union citizens, Politico reports.
Meanwhile, Moderna on Monday raised the low end of its global vaccine production estimate from 500 million doses to 600 million doses this year. The company is also planning new investments and hiring to potentially hit a target of 1 billion doses by year-end. The U.S. recently bought an additional 100 million doses from Moderna, and Canada and the European Commission expanded their orders last month. Story
The FDA put a planned phase 1 of Altimmune's intranasal vaccine candidate on hold, which the company attributed to the need for protocol modifications and additional manufacturing and quality-control info. Altimmune's candidate, AdCOVID, is an adenovirus type 5-vectored vaccine designed to offer protection after one dose. Story
Brazil is revving up for a national vaccination campaign, despite a dearth of injector devices, Reuters reports. The government plans to requisition surplus stocks from the country's syringe and needle makers, the health minister said, after an electronic auction last week turned into a fiasco.
France is "accelerating and simplifying" its vaccination program as it lags behind its European neighbors, Olivier Veran, the country's health minister, said Tuesday. France first focused on vaccinating nursing home residents and caretakers, but the government has now added healthcare workers and paramedics to that group. The plan is to start vaccinating people ages 75 and up by the end of the month.
Vaccine rollouts in other countries are also moving more slowly than expected, The New York Times reports. England aims to vaccinate some 13.9 million citizens from its four most vulnerable groups by February, Prime Minister Boris Johnson said, but as of Dec. 27, fewer than 800,000 people in the country had received the shot. In the U.S., around 4.5 million people have been vaccinated, well below the 20 million the government had aimed for.
India, which authorized AstraZeneca and Bharat Biotech's shots Sunday, plans to launch its vaccination program next week, the country's federal health secretary said. Around 29,000 cold storage facilities have been set up, and health officials carried out large-scale dry runs around the country. It's aiming to vaccinate 300 million people by July.
The Republic of Palau, an archipelago in the Pacific Ocean with a population of around 18,000, hasn't recorded a single coronavirus case or death since the pandemic began. With the arrival of 2,800 Moderna vaccine doses Saturday—which the country bought through the U.S.' Operation Warp Speed program—Palau is on its way to becoming one of the first countries vaccinated against the disease, too, CNN reports.
UPDATED: Tuesday, Jan. 5 at 9:34 a.m. ET
Mexico on Monday cleared AstraZeneca and the University of Oxford's vaccine for emergency use, Hugo López-Gatel, the country's top epidemiologist, tweeted. AstraZeneca in August laid out plans to work with the Mexican and Argentine governments to crank out 150 million initial doses for Latin America, with plans to later produce at least 400 million more doses for the region.
Israel Monday became the third country to authorize Moderna's mRNA vaccine behind Canada and the U.S. The country's health ministry has locked down 6 million doses, and deliveries are expected to begin this month, Moderna said.
Belgium is set to receive half the doses of Pfizer and BioNTech's vaccine it ordered for January, thanks to an unspecified technical hiccup last month, Yves Van Laethem, a spokesman for the country's health ministry, said. “The company Pfizer, which supplies us, will only be able to supply half of the planned doses for the month of January and so we go from 600,000 doses to a little over 300,000 doses." Belgium on Tuesday started vaccinating residents and healthcare staffers at nursing homes.
In a statement issued Monday, FDA commissioner Stephen Hahn and Peter Marks, director of the agency's Center for Biologics Evaluation and Research, said it would be "premature" and "not rooted solidly in the available evidence" to reduce the number of COVID-19 vaccine doses, extend the length of time between doses, alter the dose itself or mix and match vaccines to stretch supplies without supporting data. The U.K. recently opted to delay peoples' second vaccines in a bid to get initial shots out to more of the public. Story
The U.K.'s Emergex Vaccines teamed up with Brazil's Institute of Technology on Immunobiologicals of the Oswaldo Cruz Foundation—also known as Fiocruz—to develop a COVID-19 shot using Emergex's next-gen T-cell vaccine tech. Emergex has so far completed preclinical development work on its shot, including toxicology and immunoproteomic research into the MHC Class I peptide expression library for cell surface expressed peptides on coronavirus infected cells, which define an effective T-cell response against the disease, Emergex said.
Inovio tapped fledgling biotech Advaccine Biopharmaceuticals Suzhou to help develop, manufacture and market its DNA-based vaccine candidate, INO-4800, in Greater China. In exchange for those exclusive Chinese rights, Advaccine will license its plasmid manufacturing process for use with the shot and other Inovio pipeline candidates, with the right to sublicense to Inovio's manufacturing partners, the companies said. Inovio will receive $3 million upfront for the deal, and up to $108 million should the vaccine hit certain sales and regulatory milestones in China.
Novo Nordisk extended its COVID-19 patient assistance program until June 30, 2021—a bid to help people who've lost health insurance thanks to a job-status change during the pandemic. The program allows diabetes patients using Novo Nordisk insulin to receive insulin free of charge for 90 days. Patients can also potentially receive a free, one-time supply of up to three vials or two pen packs of insulin in instances where rationing may be a concern, Novo says.
An Advocate Aurora Health pharmacist who left out 57 vials of Moderna's vaccine was deliberately trying to spoil the shots because he feared they would mutate peoples' DNA, the Associated Press reports. Wisconsin's Steven Brandenburg, arrested last week, could face charges for the move that sent enough vaccine product for 500 people down the drain.
UPDATED: Monday, Jan. 4 at 3:26 p.m. ET
While the U.K. is delaying second doses of AstraZeneca and Pfizer's vaccines to allow more people to get the initial shot, U.S. health officials are none too keen on the idea, The New York Times reports. “I would not be in favor of that,” NIAID director Anthony Fauci told CNN last week. Others fear the country's piecemeal approach to shot distribution would only be complicated further by the switch. “Doubling the number of doses doesn’t double your capacity to give doses," Saad Omer, a vaccine expert at Yale University, told the Times.
South Korea kicked off its review of AstraZeneca's vaccine, with a view to approve the shot for emergency use in 40 days, the country's drug safety ministry said. South Korea in December inked a deal for 20 million AZ doses, and initial shipments could arrive as early as this month. The country also has deals with Pfizer, Moderna and Johnson & Johnson, with plans to start vaccinations in February.
RedHill Biopharma's oral SK2 inhibitor opaganib appears to help COVID-19 patients on oxygen support, phase 2 data showed, though a larger study is needed to confirm the experimental cancer med's benefit. Among 40 participants who developed pneumonia and required oxygen, RedHill reported a 68% reduction in the median total oxygen needed for patients on opaganib, compared to a 46.7% reduction in the control arm. The company's data reveal didn't include a statistical analysis. RedHill launched a 270-subject phase 2/3 last summer and expects top-line results in Q1. Story
Acrotech Biopharma's lymphoma drug Folotyn (pralatrexate) inhibited replication of the coronavirus more strongly than Gilead's antiviral Veklury (remdesivir), researchers at the Chinese Academy of Sciences’ Shenzhen Institutes of Advanced Technology (SIAT) found. The chemotherapy's side effects could limit its use in COVID-19 patients, but the study supports the use of hybrid virtual screening for pandemic drug repurposing, the team figures. It used different AI platforms to screen a library of 1,906 currently marketed drugs that could bind to the coronavirus’s RNA-dependent RNA polymerase. Story
India's Bharat Biotech signed a letter of intent with Malvern, Pennsylvania-based Ocugen to co-develop its inactivated vaccine, Covaxin, for the U.S. market. Ocugen is on deck for clinical development, registration, and commercialization stateside. The companies plan to finalize the deal "in the next few weeks," while Ocugen says it has set up a vaccine scientific advisory board to chart the shot's path to market. Bharat's vaccine won an emergency nod in India on Jan. 3.
Meanwhile, Bharat's authorization, which came just seven weeks after the drugmaker kicked off phase 3 trials, is taking heat from local experts, Quartz India reports. “The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers," a member of the All India Drug Action Network (AIDAN) said in a statement. The Indian government said it authorized Bharat's vaccine on “safety and immunogenicity data,” but did not include efficacy data in its approval announcement.
UPDATED: Monday, Jan. 4 at 9:26 a.m. ET
By the third week of January, AstraZeneca aims to double vaccine production to 2 million doses per week, an anonymous staffer told Business Insider. AZ has pledged 100 million doses to the U.K., where its vaccine was authorized last week. The U.K. government has said some 530,000 AZ doses should be available in the country Monday, local outlet Channel 4 News reported.
Meanwhile, 82-year-old dialysis patient Brian Pinker on Monday became the first person in the U.K. to receive AstraZeneca and the University of Oxford's shot following the late-December authorization.
AstraZeneca's vaccine snagged an emergency nod in India, where it's being produced by Serum Institute of India (SII) under the name Covishield. SII has pledged to crank out 1 billion AZ doses for developing nations, including India. The country's drug regulator also authorized Bharat Biotech's inactivated shot Covaxin. The country has laid out a goal to vaccinate 300 million people—a mix of healthcare workers, older citizens and others—by August 2021.
Thanks to stockpiling efforts, Covishield doses are ready to roll out "in the coming weeks," Serum Institute of India CEO Adar Poonawalla said. AstraZeneca's vaccine could be easier to store and distribute, too; unlike mRNA vaccines, which must be stored at ultracold temperatures, Covishield can be kept at 2 to 8 degrees Celsius (about 36 to 46 degrees Fahrenheit)—about as chilly as your standard refrigerator.
Moderna's mRNA vaccine, administered at two doses 28 days apart, proved 94.1% effective against COVID-19, phase 3 data published in the New England Journal of Medicine showed. The final analysis covered 196 coronavirus cases, with 185 cases observed in the placebo group and 11 cases recorded in the vaccine arm. Moderna is plotting additional trials of its vaccine in pregnant women, children below the age of 12 and special risk groups like the immunocompromised.
Moderna and the FDA are considering giving people a half-dose of the drugmaker's shot to expedite vaccination efforts, Operation Warp Speed chief Moncef Slaoui told CBS. “We know it induces identical immune response," he said of the half dose, adding that the move would help the government immunize "double the number of people with the doses we have." U.S. officials originally outlined a goal to vaccinate 20 million Americans by the end of 2020. As of Saturday morning, the CDC said it had administered 4,225,756 vaccine doses out of a total 13,071,925 delivered. Story
A small number of people with facial fillers who received Moderna's vaccine in the company's phase 3 study experienced facial swelling, the FDA advisory committee reviewing the shot said. “What happens is you take a vaccine and suddenly your immune system ramps up," plastic surgeon Amir Karam told NBC 7 San Diego. "The thinking is basically because of that effect of the immune system it’s targeting the areas that you have filler in and causes a more robust inflammatory response." The side effect is easily treated and shouldn't discourage people from getting the vaccine, he added.
Pfizer and BioNTech are offering South Africa 50 million vaccine doses for healthcare workers between March and the end of 2021, though the cost is "prohibitive," the country's presidency, speaking on behalf of the African Union, told Bloomberg. South Africa is also in supply talks with Johnson & Johnson, Pfizer and AstraZeneca, which has directed the country to source its shots through Serum Institute of India.
Pfizer is pushing for people to receive their second vaccine dose within the recommended 21-day period, warning, "there is no data to demonstrate that protection after the first dose is sustained" after that time. Britain's Joint Committee on Vaccination and Immunisation has since recommended vaccinating more people in at-risk groups before giving others their second doses.
UPDATED: Tuesday, Dec. 22 at 8:47 a.m. ET
Amid concern about the new coronavirus variant spreading in England, BioNTech CEO Ugur Sahin said the company is confident its vaccine will work against the strain. It's "highly likely that the immune response by this vaccine also can deal with the new virus variants," he said.
So far during the vaccination push with the Pfizer and BioNTech shot, there have been eight cases of severe allergy-like reactions, Science reports. There's a growing suspicion among some scientists that polyethylene glycol, a compound in the mRNA packaging, could be responsible. Others doubt the link. The U.S. plans to investigate.
CureVac has launched another pivotal study for its coronavirus vaccine. The biotech started a phase 3 trial of its vaccine, CVnCoV, in healthcare workers in partnership with the University Medical Center Mainz. The trial will enroll 2,500 people 18 and older and test the vaccine against placebo for the workers, who are at a higher risk of becoming infected than the general population.
Johnson & Johnson originally planned to recruit 60,000 participants for its global phase 3 vaccine trial, but earlier this month said it would halt enrollment at around 40,000 people. The company says it can still seek a U.S. authorization in early 2021, but doctors at trial sites in South America were disappointed in the company's decision to abruptly halt recruitment, Reuters reports.
Amid Novavax's push to complete vaccine testing and potentially seek an emergency use authorization, the biotech has named a chief operating officer. Rick Crowley, who previously served at TerSera Pharmaceuticals, Crealta Pharmaceuticals and other companies, is joining the biotech.
Following the Committee for Medicinal Products for Human Use's endorsement of Pfizer and BioNTech's vaccine, the European Medicines Agency has formally approved the shot. The distribution across Europe is set to start later this week.
The U.S. Attorney's Office for the District of Maryland has seized and shut down fake websites claiming to represent Moderna and Regeneron. The sites stole user information for cyberattacks.
UPDATED: Monday, Dec. 21 at 3:02 p.m. ET
Codagenix and the Serum Institute of India (SII) launched a 48-subject phase 1 study in the U.K. to assess the safety, tolerability and immunogenicity of their single-dose, intranasal COVID-19 vaccine. Dosing at an hVIVO-run site is pegged to start early next year. While that puts the partners well behind the leading developers in the vaccine race, Codagenix and SII's candidate could carve out a niche if booster shots are needed to maintain protection against the virus. Plus, the partners' candidate, COVI-VAC, is stable beyond the subzero temps needed to store Pfizer's shot. Story
IBM is pairing its Digital Health Pass app with Salesforce's online employee management platform, Work.com, to help businesses and public spaces reopen as COVID-19 vaccines become available. IBM's app aims to provide personalized, sharable health credentials after vaccinations, temperature checks and test results via an encrypted digital wallet on a smartphone, plus contract tracing and other services. Story
Beckman Coulter sketched out launch plans for a $4 antigen test designed for mass screening, with the goal to ship up to 25 million units per month by March. The Access antigen assay, which runs on high-throughput laboratory hardware, can deliver individual results in 30 minutes while processing up to 200 samples per hour. The company is currently submitting the test to the FDA for an emergency nod, Beckman Coulter said. Story
Walgreens Boots Alliance and CVS Health are spearheading a program, in partnership with the federal government, to vaccinate roughly 7 million people in more than 70,000 long-term care facilities across the U.S. While some residents received shots last week, the partners' full rollout kicked off Monday, Reuters reports.
The FDA turned back Novartis' cholesterol drug inclisiran—cornerstone of the Swiss Pharma's $9.7 billion buyout of The Medicines Company—thanks to “unresolved facility inspection-related conditions." The agency didn't take issue with the drug's safety or efficacy, Novartis said. The holdup is "essentially due to COVID-19 travel restrictions (FDA couldn't inspect a third-party facility)," an RBC Capital Markets analyst wrote Sunday. It's a fate shared by BMS' CAR-T hopeful liso-cel, which recently had its approval timeline pushed back after the FDA missed an on-site inspection. Story
Most agree the industry's pandemic pivot to digital marketing is here to stay. "[There’s] no going back now—we are going to digitalize healthcare,” Marie-France Tschudin, president of Novartis Pharmaceuticals, said in July. Meanwhile, pharma marketers and sales reps are getting more creative on the virtual front: Razorfish Health, for instance, created healthcare provider mailers for a new drug launch, complete with an Amazon Dash button, which, when pressed, sends out a request for a sales rep call or drug samples. Story
Meanwhile, telemedicine could be here to stay, too. Nearly 80% of specialists in the U.S. say they've started using telemedicine tech to reach more patients this year, a GlobalData survey found, with more than 75% of respondents saying they planned to keep using the tech after the pandemic. Elsewhere, digitally minded companies like Everlywell, Pear Therapeutics and Evidation Health have bagged millions of investment dollars to grow their telehealth offerings in 2020. Story
UPDATED: Monday, Dec. 21 at 9:05 a.m. ET
The FDA on Friday cleared Moderna's mRNA vaccine for emergency use in people ages 18 and older, teeing up immediate, nationwide distribution for the U.S.' second authorized COVID-19 shot. Moderna plans to deploy 20 million doses to the U.S. by year-end, while Pfizer, first to authorization, has pledged 25 million doses. Both companies say they're on track to deliver 100 million doses by the end of the first quarter, while Moderna recently agreed to supply 100 million more shots in the second quarter. Story
The EMA's Committee for Medicinal Products for Human Use (CHMP) on Monday vouched for the conditional marketing authorization of Pfizer and BioNTech's mRNA vaccine in people ages 16 and older in Europe. The European Commission is set to review and potentially rubber-stamp the CHMP's decision "in the near future," Pfizer and BioNTech said in a release. If the commission grants Pfizer's shot a CMA, the decision will immediately extend to all 27 EU member states.
China aims to vaccinate 50 million people before Feb. 15—the date of the Lunar New Year, when many people are expected to travel, a Shanghai vaccine expert and former immunologist with the city's CDC said during a teleconference with China's National Health Commission. The country currently has five vaccine candidates in late-stage testing.
President-elect Joe Biden and incoming First Lady Jill Biden will receive Pfizer's vaccine on live television Monday morning. Meanwhile, Vice President-elect Kamala Harris plans to get her shot after Christmas, on the advice of doctors who suggested she and Biden stagger their first injections. Last week, Vice President Mike Pence became the highest-ranking elected U.S. official to receive the vaccine when he, Second Lady Karen Pence and Surgeon General Jerome Adams rolled up their sleeves to get Pfizer's shot—also on live TV.
With authorizations for Pfizer and Moderna's vaccines locked in, Johnson & Johnson is the next likely contender to apply for approval stateside, Admiral Brett Giroir, M.D., assistant secretary at the Department of Health and Human Services, told ABC News. J&J is expected to submit its adenovirus hopeful for authorization in January, Giroir said. The drugmaker last week said it had finished recruiting for its phase 3 trial and aims to deliver early efficacy data by the end of next month.
A new strain of COVID-19 first detected in the U.K. spreads quickly, and work is underway to determine whether it leads to higher mortality, too, Chris Whitty, England's chief medical officer, said in a statement Saturday. “As a result of the rapid spread of the new variant, preliminary modeling data and rapidly rising incidence rates in the South East, the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) now consider that the new strain can spread more quickly," he said.
Italy on Sunday reported it had one patient infected with the new strain of the coronavirus found in Britain. The patient, now in isolation, recently returned from a trip to the U.K., Italy's health ministry said. Meanwhile, Australia on Monday confirmed it had identified two patients infected with the new strain.
UPDATED: Friday, Dec. 18 at 3:20 p.m. ET
Belgium's budget state secretary, Eva De Bleeker, tweeted—and then deleted—the prices the EU has negotiated for Pfizer and Moderna's vaccines, The New York Times reports. Pfizer's shot, due for a European approval decision Monday, will cost €12 ($14.70) per dose, bringing up the cost for a full two-dose course to €24 ($29.38). Moderna's shot will cost $18 per dose, or $36 for a full course, according to the leaked price list.
The National Institutes of Health kicked off dosing in sub-studies of GlaxoSmithKline and Vir Biotechnology's antibody hopeful, plus a two-antibody combo from Brii Biosciences. To start, researchers will test the two drug regimens against placebo in 450 subjects hospitalized with mild to moderate COVID-19. An initial readout, expected five days after dosing, will look at a range of factors like symptoms, how easily patients can perform daily activities and risk of death. If the drugs fare well, they'll move into 700-subject trials that include patients with more severe COVID-19. Story
The FDA authorized a new version of Abbott's speedy BinaxNOW antigen test that people can use at home with a prescription. Users aged 15 and up can take their own nose swab samples, while adults can use the swab on children as young as 4. Users are guided through the process via a telehealth connection. In partnership with digital service provider eMed, Abbott aims to deliver 30 million BinaxNOW tests by the end of March and another 90 million before the end of June. EMed, meanwhile, will pass off testing results to the relevant public health authorities. Story
COVAX, the World Health Organization's equitable vaccine distribution scheme, has secured nearly 2 billion vaccine doses through additional supply talks with AstraZeneca and Johnson & Johnson, the alliance said Friday. COVAX aims to start deliveries in the first quarter of 2021, assuming the shots are approved. It expects enough doses in 2021's first half to protect healthcare workers in all participating countries and economies and plans to deliver at least 1.3 billion doses to 92 low- and lower-middle income countries enrolled in the program sometime next year.
The vaccination will be televised. Vice President Mike Pence, second lady Karen Pence and Surgeon General Jerome Adams rolled up their sleeves to get Pfizer's vaccine on live television Friday morning, making Pence the highest-ranking elected U.S. official to get the shot. After receiving the vaccine, Pence said he hoped the move would "affirm to the American people that hope is on the way," adding that he "wanted to step forward and take this vaccine to assure the American people that while we cut red tape, we cut no corners.”
UPDATED: Friday, Dec. 18 at 11:45 a.m. ET
The FDA's panel of vaccine experts voted 20-0 Thursday, with one abstention, that the benefits of Moderna's mRNA shot outweigh the risks for people 18 and older. With Moderna's vaccine now positioned for a swift authorization, panelists did raise concerns that an emergency nod could disrupt the company's ongoing trial. Others pointed to cases of facial paralysis—a condition known as Bell's palsy—that cropped up during the study. The FDA is investigating the side effect but “has no basis to conclude a causal relationship” between the paralysis and the vaccine, an agency official said. Story
The European Commission tapped its option to purchase another 80 million Moderna vaccine doses, raising the bloc's total purchase to 160 million doses. Moderna aims to kick off deliveries to Europe in early 2021, subject to regulatory approval. The European Medicines Agency’s scientific committee for human medicines is set to review the shot on Jan. 6, and then the European Commission will decide whether to authorize it.
Johnson & Johnson on Thursday said it had wrapped enrollment for its late-stage vaccine trial and expects to release initial efficacy data by the end of January. If all goes to plan, J&J aims to submit its vaccine to the FDA in February and apply for authorization in other countries "in parallel." The phase 3 kicked off in September, with study sites up and running in the U.S., South Africa, Brazil, Argentina and several other Latin American countries. Meanwhile, Health Canada launched a rolling review of the vaccine late last month.
A healthcare worker in Alaska suffered flushing and shortness of breath 10 minutes after receiving Pfizer's vaccine, the states' health department said. She had no previous history of allergies and is now in stable condition. Meanwhile, a second staffer at the same Alaskan hospital was hit with eye puffiness, lightheadedness and scratchy throat 10 minutes after receiving the shot, though this second case was not considered anaphylaxis.
Regeneron's antibody cocktail successfully reduced viral load and the need for medical visits in non-hospitalized, recently infected COVID-19 patients, with the greatest benefit seen in those who'd yet to mount their own effective immune response or had high viral load at baseline, initial data from a phase 1/2/3 trial published in The New England Journal of Medicine showed. Regeneron's cocktail won an emergency nod in late November to treat non-hospitalized, mild-to-moderate patients at high risk for progressing to severe COVID-19.
Speaking of Regeneron, President Donald Trump personally stepped in to help Housing Secretary Ben Carson get the drugmaker's antibody cocktail after he was hospitalized with COVID-19 last month, Carson told Fox News. Carson initially tried to treat himself with oleander extract—an unproven treatment derived from a toxic plant, which Trump and MyPillow executive Mike Lindell pushed aggressively over the summer.
UPDATED: Thursday, Dec. 17 at 3:39 p.m. ET
After HHS secretary Alex Azar said Pfizer was having some issues with its COVID-19 vaccine production, the company refuted the statement on Thursday. Pfizer "is not having any production issues" and "no shipments containing the vaccine are on hold or delayed," the company said. At a press event Wednesday, Azar said the government had "recently been informed by them, finally, of various challenges" in the manufacturing process. Story
The United States' second COVID-19 vaccine could be nearing an FDA emergency authorization. On Thursday, an advisory committee met to discuss Moderna's application, with C-SPAN streaming the event. A vote on whether to recommend Moderna's vaccine was expected around 5:15 p.m. ET.
Meanwhile, the effort to scale up COVID-19 vaccines is affecting other medicines in the pharmaceutical supply chain. Horizon said its thyroid eye disease med Tepezza will run scarce from the end of the month into 2021 as its contract manufacturer Catalent helps with coronavirus vaccine production. Story
Throughout the pandemic, market watchers have wondered whether the pharmaceutical industry would see major reputation gains. A new study in the U.K. from Takeda finds that's not the case, as only 17% of adults surveyed in October said their perception of the industry had improved. Story
UPDATED: Thursday, Dec. 17 at 11:23 a.m. ET
Vials of Pfizer's vaccine, designed to hold five doses, contain enough product for pharmacists to squeeze out a sixth or seventh dose, Stat News first reported. Without clear manufacturer or regulatory approval, that extra supply has so far been discarded. Now, the FDA is suggesting healthcare workers "use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue,” an agency representative told Reuters.
Speaking of Pfizer, why hasn't CEO Albert Bourla taken the drugmaker's vaccine yet? "I'm 59 years old, in good health, I'm not working on the frontline, so my type it is not recommended to get vaccination now," he told CNN, suggesting it would "set a bad example" to "cut the queue."
Japanese health authorities have questions about the efficacy of Fujifilm's flu med Avigan in COVID-19, Kyodo News reported. Fujifilm started seeking approval in October after late-stage data showed its antiviral sped recovery time in patients with less-severe symptoms. Japan's drug regulator is due to make a decision on Dec. 21, though it's concerned doctors involved in the trial were aware which patients got the drug or placebo, government sources told Kyodo.
Utah’s Intermountain Healthcare says it’s trained a dedicated team, dubbed “the MAb Squad,” to contact high-risk individuals the moment they receive a positive COVID-19 testing result, helping connect them with infusion centers to receive Eli Lilly and Regeneron’s monoclonal antibody drugs. Demand for the companies' antibodies, which must be administered soon after a person contracts COVID-19, has been underwhelming, Operation Warp Speed's Moncef Slaoui said Wednesday.
Some 15,000 people in Moscow have received Russia's Sputnik V vaccine since the the country kicked off large-scale vaccination efforts on Dec. 5, but enthusiasm for the shot has been mixed, the Los Angeles Times reports. Russia approved its shot this summer before wrapping up late-stage trials. It has since kicked off a phase 3, though public confidence may already be damaged. An October poll from the country's Levada Center found 59% of Russians were unwilling to get the shot, with many wary that the "raw" vaccine was rushed to secure a world-first approval.
UPDATED: Wednesday, Dec. 16 at 3:15 p.m. ET
Most U.S. doses of Regeneron and Eli Lilly's antibodies remain unused, Operation Warp Speed chief Moncef Slaoui told CNBC. Of some 65,000 total doses shipped out each week, only 5% to 20% end up reaching patients, he said. Some hospitals say they're too overwhelmed to handle the logistics of prioritizing patients for treatment. As The Verge points out, patients also have a narrow window of time—soon after contracting COVID-19—when they could benefit from Lilly and Regeneron's drugs.
A lab technician at a Sanofi vaccine plant in Swiftwater, Pennsylvania, sued the company and the staffing firm Yoh for failing to deliver pandemic hazard pay as promised. A project manager this spring emailed more than 60 technicians to offer a 15% pay bump for the duration of the pandemic as compensation for "increased risk of exposure," but as the weeks went on, employees noticed their wages hadn't increased, the lawsuit alleges. The staffers were ultimately offered three extra days paid time off, the suit says, which the same manager later told them was "in lieu of hazard pay." Story
The FDA cleared Ellume's over-the-counter, home COVID-19 test for emergency use. The Ellume COVID-19 Home Test detects fragments of proteins of the coronavirus from a nasal swab and uses an analyzer that connects with a smartphone app to help users perform the test and interpret results. Ellume expects to crank out some 3 million tests by next month and 20 million by the second half of 2021. Story
Data analytics firm nference picked up $60 million in a series C funding round, building on a previous $60 million it raised in January. With the new cash, the company says it will to broaden its focus to include “biomedical data analytics to better understand the novel coronavirus." This includes nference's recent project to demystify COVID-19 transmission, the symptoms and progression of the disease and “diagnostic predictions of chronic and life-threatening conditions such as pulmonary hypertension,” the company said. Story
French shot developer Valneva kicked off a phase 1/2 trial of its inactivated, adjuvanted vaccine hopeful. The vaccine leverages the manufacturing platform of the company's approved Japanese encephalitis shot, Ixiaro, Valneva said in a release. To start, the company will study the safety and immunogenicity of three dose levels in around 150 healthy adults at sites across the U.K. Valneva aims to pick an optimal dose by 2021's second quarter and, if all goes to plan, believes it could snare an initial approval as early as the end of next year.
British American Tobacco—well-known for its cigarette brand Lucky Strike—bagged U.S. approval to run in-human trials of a COVID-19 vaccine made using tobacco plants, The Guardian reports. The company's biotechnology division, Kentucky BioProcessing (KBP), says it can turn tobacco crops into “bio-manufacturing factories” by inserting a potential antigen into the plants for reproduction. The company's unusual approach could be faster, too: up to 3 million "factory" plants can be grown, harvested and processed within six weeks, KBP said.
UPDATED: Wednesday, Dec. 16 at 9:31 a.m. ET
Pfizer is in talks with the U.S. government to free up supplies for extra vaccine doses, The New York Times reports, citing sources close to the matter. Pfizer may be able to manufacture more shots for the U.S.—beyond the 100 million it's pledged to deliver by March—if the government orders its suppliers to prioritize its purchase requests. The company is now hashing out a contract with the government to potentially provide more doses from April to the end of June, NYT said. Story
White House press secretary Kayleigh McEnany on Tuesday said the Trump Administration was angling for an additional 100 million Pfizer doses, but didn't specify when the order might arrive. Pfizer "can provide" the doses, CEO Albert Bourla told CNN earlier this week, but he added that "most of that we can provide in the third quarter." The two parties are working "collaboratively" to find ways to produce more doses in the second quarter, he said.
Meanwhile, the Trump Administration turned down an offer to secure more Pfizer doses as recently as November, former FDA commissioner and Pfizer board member Scott Gottlieb said on CNBC's Squawk Box. "I think hopefully we’ll find a way to increase supply and be able to get the government what the government needs,” he said.
BioNTech will supply 100 million vaccine doses to China as part of an agreement with the country's Shanghai Fosun. The company will source the initial shipment from its production facilities in Germany. BioNTech and Fosun first teamed up in March to develop and commercialize a shot using BioNTech's mRNA platform. The companies kicked off a phase 2 trial of the vaccine in China in late November. Meanwhile, BioNTech and Pfizer's vaccine already boasts an emergency nod in countries like the U.S. and the U.K.
Long Island-based Codagenix got the OK to start a phase 1 trial of its nose drop COVID-19 vaccine in the U.K. The 48-subject trial is slated to kick off in the first week of January. Codagenix's candidate, COVI-VAC, is designed to work after one dose and “may induce a more robust immune response and long-lasting cellular immunity," the company said.
The University of California, San Francisco, is set to receive its first allocation of Pfizer doses in mid-December—but that's just the start of the journey, Desi Kotis, chief pharmacy executive at UCSF health, told Fast Company. Once the university starts vaccinating people, it will send the CDC and the California Department of Public Health an accountability log of the number of doses administered each day. Meanwhile, the school is working with ethicists, doctors and health equity experts to determine who should receive the first doses.
The drug manufacturing industry in Bihar, India, is having a rough go of it amid the pandemic, and the government seems unwilling to help, Pharmabiz reports. The coronavirus has spurred losses of production, revenue and employment in the industry. Earlier this year, drug manufacturing facilities in Baddi, Himachal Pradesh, India, shut down after the region was declared a COVID-19 containment zone.
Amid pandemic supply constraints, South Africa is facing shortages of lithium, used to treat bipolar disorder, and the injectable contraceptives Depo-Provera and Nur-Isterate, made by Aspen Pharmacare and Bayer, respectively, Ruth Dube, project coordinator at the Stop Stockouts Project—a non-profit that looks to end medication scarcity—told Bloomberg. Meanwhile, Pfizer in September stopped South African manufacturing of intramuscular haloperidol, used to treat mood disorders, for "reasons beyond its control," the company's South African communications chief said.
UPDATED: Tuesday, Dec. 15 at 3:15 p.m. ET
Eli Lilly's antibody treatment bamlanivimab and its immunology med Olumiant could add up to $2 billion in COVID-19 sales this year, the drugmaker said Tuesday. Pandemic profits, plus strong demand for several core products like Lilly's diabetes drug Trulicity and its psoriasis med Taltz prompted the company to hike its year-end revenue forecast to $24.2 billion to $24.7 billion. In 2021, Lilly predicts revenues will fall between $26.5 billion to $28 billion. Story
The U.S. government should invest in production of Eli Lilly and Regeneron’s pandemic antibodies as an “insurance policy” against COVID-19 next year, former FDA chief Scott Gottlieb wrote in The Wall Street Journal. The government could pay companies for access to their manufacturing space and help blunt the risks for those willing to become contract manufacturers for the treatments, he said. The government should also stockpile raw ingredients for the drugs at a “worthwhile” price, shoring up supplies ahead of next winter. Story
President-elect Joe Biden and Vice President-elect Kamala Harris should both get Pfizer's vaccine—as should President Donald Trump and Vice President Mike Pence, Anthony Fauci said Tuesday. Biden and Harris should get the shot as soon as possible, Fauci said, adding that Trump, who tested positive for COVID-19 in October, should also get one since his current level of natural resistance is unclear. Trump on Sunday said he wasn't schedule to get the shot and suggested White House staffers wait until “somewhat later in the program" to receive one.
As shot authorizations start to trickle in, 71% of Americans say they would get a COVID-19 vaccine if it were free and proven safe and effective—up from 63% in September, a new Kaiser Family Foundation survey found. Twenty-seven percent of the public remains vaccine hesitant, with skepticism highest among republicans at 42%. Among Black adults—a group hit disproportionately hard by the pandemic—35% said they definitely wouldn't or probably wouldn't get vaccinated. The poll surveyed 1,676 people between Nov. 30 and Dec. 8.
The U.S. Defense Advanced Research Projects Agency (DARPA) awarded a $37.6 million grant to Inovio, the Wistar Institute, AstraZeneca, the University of Pennsylvania and Indiana University to leverage Inovio's platform to develop DNA-encoded monoclonal antibodies (dMAb) against SARS-CoV-2. To start, Inovio and Wistar will construct dMAb candidates mirroring the recombinant antibodies AZ has already pushed into clinical studies.
Biogen’s ill-fated management conference has been linked to hundreds of thousands of coronavirus cases, researchers estimate in an article published in Science. As of Nov. 1, at least one viral variant that may have hitched a ride over from Europe with an attendee had made its way to 245,000 people in the U.S., while another that emerged during or right after the Biogen conference reached 88,000, the researchers said. Story
Russia's Sputnik V vaccine is 91.4% effective, interim phase 3 data published Monday by the country's sovereign wealth fund showed. The readout covered 22,714 participants who got either placebo or the vaccine in Russia's late-stage trial. Seventy-eight people became infected with COVID-19 across both groups. Twenty severe cases were logged in the placebo arm, while no one who got the vaccine became seriously ill.
UPDATED: Tuesday, Dec. 15 at 9:20 a.m. ET
Moderna's mRNA vaccine won a thumbs-up from FDA staffers ahead of Thursday's hotly anticipated advisory committee review. The agency reviewers highlighted the shot's overall 94.5% efficacy rate, but noted that it appears to work better in patients under 65. Efficacy landed at 95.6% in that age group, compared with 86.4% for people 65 and older. The agency also vouched for the shot's "favorable safety profile," though many patients did experience mild side effects like injection site pain, fatigue and headaches, the FDA said. In an intriguing addendum to its own briefing documents, Moderna added its shot could prevent asymptomatic infection after one dose. Story
The European Medicines Agency aims to approve Pfizer and BioNTech's vaccine on Dec. 23, Germany's Bild reported. The agency would make an approval decision by Dec. 29 at the latest, an EMA spokesperson added. Meanwhile, Germany could kick off vaccination efforts over the Christmas holiday, Bild reports.
The first round of efficacy data from Johnson & Johnson's phase 3 vaccine trial could arrive in early January—potentially teeing up an emergency nod later that month, Warp Speed chief Moncef Slaoui said. AstraZeneca's efficacy readout is expected in late January, and the company could file for emergency use later in February, Slaoui said.
Some of Moderna's COVID-19 vaccine documents were breached in a cyberattack targeting the European Medicines Agency, the biotech said. None of the data Moderna submitted contained identifying information on study participants and so far, there's no evidence that any trial subjects have been ID'd, Moderna said. Last week, the EMA revealed hackers behind the same attack had accessed documents from Pfizer and BioNTech. Story
Pfizer's shots are making their way across the U.S., CBS Philly reports. Temple University Hospital in Philadelphia expects to get 2,000 doses this week, with the goal to ultimately immunize between 7,000 and 8,000 patient-facing employees across its sites. Delaware on Monday received its first 9,000-dose shipment and will start giving the shot to frontline workers Tuesday. Meanwhile, the Cooper health system in New Jersey also plans to kick off vaccination efforts today.
All told, Pfizer's vaccine made it to 141 out of 145 target locations in the U.S. Monday, an HHS spokeswoman told Metro US. Healthcare facilities in the island territories of American Samoa, the U.S. Virgin Islands, the North Mariana Islands and Guam are still waiting on shipments, she said. Meanwhile, severe storms expected in the U.S. this week could hamper ongoing distribution plans, Operation Warp Speed's Gen. Gustave Perna said.
AstraZeneca removed children from a phase 2/3 study of its vaccine hopeful in the U.K., the United States clinical trial registry showed. Pfizer, Johnson & Johnson and Moderna are all testing their shots in kids to see how they work across a wider range of age groups.
The World Health Organization is in talks with Pfizer to include its shot in a global vaccine rollout, Bruce Aylward, a senior adviser at the agency, told Reuters. Aylward said he saw a "strong commitment" from Pfizer chief Albert Bourla to price shots fairly for poorer nations. Meanwhile, the agency expects to release information on additional manufacturers joining its COVAX vaccine facility in the coming weeks, he said.
Brazil's Sao Paulo state plans to release efficacy data on Sinovac's shot on Dec. 23, eight days later than planned, Reuters reports. That extra time will allow researchers to include data on a sample of 151 infected people, completing the analysis, the head of the state's COVID-19 response said. Sao Paulo has set a vaccine rollout date for Jan. 25, though Sinovac's shot has yet to win approval and has been met with frequent opposition from President Jair Bolsonaro.
China's Sinopharm expects to have capacity to crank out 1 billion COVID-19 vaccine doses next year, Chinanews reports. The company has two inactivated vaccine candidates in phase 3 trials across 10 countries and regions, Yang Xiaoming, Sinopharm's president, said. As it stands, Sinopharm's plants in Wuhan and Beijing have a combined capacity of 300 million doses per year.
South Korea's drug regulator cleared Celltrion's experimental COVID-19 antibody treatment in patients with life-threatening disease. Under South Korea's treatment scheme, patients with potentially fatal conditions and no other treatment options can receive drugs still in clinical trials, the Ministry of Food and Drug Safety said. Celltrion's antibody is currently in phase 2 and phase 3 studies. The company plans to pursue an emergency nod before the end of the year.
A new strain of the coronavirus surfaced in the U.K., with more than 1,000 cases of the new variant found "predominantly in the South East" Monday, health secretary Matt Hancock said. Dubbed VUI-202012/01, the strain has also been identified in Wales. The new variant is spreading faster than the existing coronavirus strain, but it's too early to say how it will affect the virus' overall behavior, Hancock said. The mutation can still be detected by COVID-19 tests, another official added.
UPDATED: Monday, Dec. 14 at 3:05 p.m. ET
The U.S. government on Monday tapped its option to buy an additional 100 million doses of Moderna's vaccine for around $1.68 billion, raising the country's total order to 200 million doses—enough to vaccinate 100 million people. The biotech said it plans to distribute the new order in 2021's second quarter. Ahead of that, it plans to ship out some 20 million doses this month and deliver 80 million more by next year's first quarter, provided it wins an FDA emergency nod. Story
Vaccinations with Pfizer's shot kicked off in the U.S. Monday, less than 11 months after the country's first COVID-19 case, but the nation isn't out of the woods yet, SVB Leerink analysts pointed out. Shot hesitancy among the public is one major concern, with recent reports of anaphylaxis and Bell's palsy after vaccination adding to those worries, the analysts wrote. Supply and storage could create additional hurdles, while R&D setbacks for Sanofi, GSK and AstraZeneca may limit the U.S.' backup options behind Pfizer and Moderna's shots. Story
Eli Lilly's Olumiant (baricitinib) plus Gilead's Veklury—also known as remdesivir—may work better than Veklury alone in hospitalized COVID-19 patients on high-flow oxygen or non-invasive ventilation, a study published in the New England Journal of Medicine found. Among that group, patients who got the combination treatment had a median recovery time of 10 days, compared to 18 days in the group that received solo Veklury.
Eureka Therapeutics' antibody nasal spray InvisiMask protected mice against SARS-CoV-2 pseudovirus for at least 10 hours, even at the lowest concentrations tested, researchers described in a paper on bioRxiv. The drug could work as a daily preventive measure against COVID-19, said Eureka, which is currently working on a clinical trial application with the FDA. Eureka's monoclonal antibody targets the virus' spike protein and has been further modified to increase its binding to mucin—a bid to extend the retention time of the drug in the respiratory tract. Story
In a preclinical trial, ImmunityBio's oral COVID-19 vaccine raised levels of anti-spike antibodies in almost all 10 nonhuman primates who received the candidate. Five primates got subcutaneous doses on days 0 and 14, followed by an oral tablet on day 28. The other five received a subQ primer dose to start, but switched to the oral formulation for the two boosters. The company plans to move the oral formulation into phase 1 testing alone and as a boost to a subcutaneous shot in a mixed regimen. Immunity launched a phase 1 trial of its injectable formulation in October. Story
A finger-worn sensor from Oura may help reliably detect an oncoming fever before a person feels the effects, a proof-of-concept study showed. The results could position the device as an early warning system for spotting a major symptom of COVID-19, researchers running the Oura-funded study said. Data were gathered from a group of 50 participants who reported contracting COVID-19 and are the first to be published out of a larger, 65,000-subject trial of the Oura ring. Story
Parisian diagnostics firm Novacyt launched a research-use-only polymerase chain reaction (PCR) test for a new strain of COVID-19. The test homes in on the Y453F viral mutation originally found in mink in Denmark and the Netherlands. The mutation quickly spread to humans and has been detected outside of Europe. Story
Top U.S. infectious disease expert Anthony Fauci stars in the first phase of the Department of Health and Human Services' troubled, $250-million ad campaign to build public confidence in a vaccine. The first video in the $500,000 "Tell Me More" digital campaign opens with reassurance from Fauci that the pandemic will end, while additional videos detail the science behind the virus and vaccine development. The effort will be followed by a $36.6 million "Slow the Spread" radio campaign, set to debut Dec. 21. Story
Primary care doctors in the U.K. will start offering doses of Pfizer and BioNTech's vaccine to their patients, a little less than a week after the country started rolling out the shot, The New York Times reports. As of Monday, vaccines are being deployed to more than 100 vaccination sites, while more doctors and pharmacies are set to join the program on a "phased basis" over the next few months, the country's National Health Service said.
UPDATED: Monday, Dec. 14 at 11:45 a.m. ET
It's official: The FDA Friday cleared Pfizer and BioNTech's mRNA shot, authorizing the first COVID-19 vaccine for emergency use in the U.S. The nod came a little more than 24 hours after the FDA's Vaccines and Related Biologics Products Advisory Committee voted 17-4, with one member abstaining, that the vaccine's benefits outweigh the risks in people over the age of 16. Story
As of Monday morning, patients started receiving Pfizer's shot at the Long Island Jewish Medical Center in Queens, New York, The New York Times reports. Across the U.S., 145 sites are expected to receive vaccine shipments today, followed by 425 sites on Tuesday and 66 Wednesday, Operation Warp Speed's Gen. Gustave Perna said.
Speaking of vaccinations, President Donald Trump Sunday said he would delay plans for senior White House staffers to receive the vaccine in the coming days, The New York Times wrote. The move came hours after The Times reported on the administration's plan to distribute the shot internally. “People working in the White House should receive the vaccine somewhat later in the program, unless specifically necessary,” the President tweeted.
FedEx, United Airlines and UPS are taking to the skies to fly the first Pfizer doses to vaccination centers around the country. United says it was the first commercial airline to ferry Pfizer's shot to the U.S. FedEx, meanwhile, will transport the vaccine using its priority overnight service, while UPS plans to move the shot from Pfizer storage sites in Michigan and Wisconsin to its UPS Worldport facilities in Louisville, Kentucky, where it will then expedite the shots to hospitals, clinics and other medical facilities.
Novartis and Incyte's JAK1/JAK 2 inhibitor Jakafi, also known as ruxolitinib, missed the mark in a phase 3 study to see whether it could help patients aged 12 years and older with COVID-19-related cytokine storm. By day 29 of the study, there was no reduction in the proportion of patients on Jakafi and standard of care who experienced severe complications, including death, respiratory failure or admission to an ICU, compared to those on standard care alone, Incyte said. The drug also failed to improve mortality rates or time to recovery by day 29.
AstraZeneca would have run the University of Oxford's vaccine trials differently if it had been in charge, Mene Pangalos, VP, biopharmaceuticals R&D at the British drugmaker, told BBC Panorama. Two full-doses of AstraZeneca's vaccine have so far proven around 62% effective, while a regimen including half-dose primer shot charted 90% efficacy in phase 3, leading to recent confusion around the vaccine's benefit. Ultimately, "it is what it is," and AZ and Oxford have done as good a job as possible to set themselves up for a potential approval, Pangalos said.
Germany's CureVac kicked off a phase 2b/3 trial of its mRNA vaccine candidate, CVnCoV. The trial will enroll 36,500 participants in Europe and Latin America with a view to generate data for a possible 2021 authorization. Unlike Moderna's mRNA shot, advanced at a 100-microgram dose, CureVac's candidate triggers immune responses at just 12 micrograms, enabling the company to pump out more doses if it snares approval. The phase 2b will generate safety, reactogenicity and immunogenicity data to inform the phase 3 start. Story
Even with Pfizer's shot authorized and a possible Moderna EUA on the horizon, the worst of the pandemic is still yet to come, Bill Gates told CNN Sunday. "Sadly the next four to six months could be the worst," the Microsoft co-founder warned. A vaccine won't be widely available until spring or summer. “In the near term, it’s bad news,” Gates said, citing an evaluation showing the U.S. could suffer more than 200,000 additional COVID-19 deaths by April 1.
Swiss biotech Relief Therapeutics, partnered with the U.S.' NeuoRx on development of a patented version of aviptadil for COVID-19 respiratory failure, has seen its share price skyrocket by 38,000% this year, CNBC reports. The companies have been in contact with Operation Warp Speed, and if their treatment passes muster in phase 3, the partners expect to receive stockpiling orders on par with those for Gilead Sciences' antiviral Veklury and Eli Lilly's monoclonal antibody bamlanivimab, Relief chairman Ram Selvaraju told the news outlet.
UPDATED: Friday, Dec. 11 at 3:15 p.m. ET
With an emergency use authorization looming, Pfizer is already looking ahead with plans to file its vaccine for a full FDA approval by April, William Gruber, SVP of vaccine clinical research and development at the company, said.
Roche has started deploying its Elecsys high-throughput antigen test across Europe, which could ease the burden on molecular-based diagnostics—the gold standard since the pandemic's start. Anticipating international demand next year, Roche aims to boost production to “a double-digit million number of tests per month." The test uses deep nose or throat swabs collected by healthcare professionals and runs on the company’s cobase immunochemistry analyzers, at up to 300 tests per hour. Story
The World Health Organization could offer a decision on Pfizer's vaccine within a "couple of weeks," Soumya Swaminathan, chief scientist at the agency, told Reuters. It may also review Moderna and AstraZeneca's vaccines in a similar timeframe, she added. A WHO authorization could potentially allow vaccines to reach countries where local regulators have not yet had the chance to review them.
Sorrento Therapeutics got a thumbs up to run a phase 1 trial of its next-generation antibody treatment, STI-2020, also known as COVI-AMG. The drug is a new-and-improved version of the company's first-gen antibody treatment COVI-GUARD, for which Sorrento has yet to publish phase 1 clinical data. To start, Sorrento will evaluate the safety, pharmacokinetics and efficacy of the drug at a single dose in healthy and non-hospitalized patients with mild COVID-19.
Teva teamed up with Villyge family benefits to help its employees better cope with work-life stresses, amplified by the COVID-19 pandemic. The partnership will result in a four-part virtual workshop series to help parents better manage work and family needs. As stay-at-home orders and school closures upend business-as-usual for working parents, women especially have had to shoulder the burden. More than 2.2 million women left the workforce between February and October due to pandemic disruptions, Teva noted in a press release. Story
The World Trade Organization Thursday considered waiving certain intellectual property rights for COVID-19 drugs, vaccines and tests—a move supported by India and South Africa, plus organizations like Médecins Sans Frontières. But those patent protections drive innovation, Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, wrote in a New York Times op-ed. Without the potential for financial reward, drugmakers wouldn't invest years—and billions—into the development of new meds, he said.
Thirty-five percent of women say they're "not very" or "not at all" interested in getting a COVID-19 vaccine, up nine percentage points from May, a Reuters and Ipsos poll found. Among that group, 60% said they were wary of the rapid fire development and approval process. Meanwhile, 68% of men and 55% of women said they would consider getting the vaccine. Convincing more women to accept the shot could be crucial to early vaccination efforts, as American mothers make some 80% of healthcare decisions for their families, according to the U.S. Department of Labor.
Russia kicked off a mass vaccination campaign with its Sputnik V shot this week, but initial turnout has been lower than expected, The Washington Post reports. Some of that hesitancy could stem from the shot's swift registration over the summer, before it completed trials. Even now, Sputnik V is still in late-stage testing, and Russian scientists have so far only published phase 1/2 results. In an October poll by the Levada Center, 59% of Russians said they wouldn't get a vaccine, while a separate, government-backed survey that same month found 73% were unwilling to get the shot.
UPDATED: Friday, Dec. 11 at 9:14 a.m. ET
The FDA's expert panel Thursday voted 17-4, with one member abstaining, that the benefits of Pfizer and BioNTech's vaccine outweigh the risks for use in people 16 and older. Some panelists raised concerns about the relatively low number of 16- to 17-year-old trial participants, however, and at least a few wanted to exclude this age group from the emergency use authorization. Panelists also discussed allergic reactions that hit two U.K. healthcare workers who received the vaccine, as well as the novelty of the drugmakers' mRNA platform. Story
Interim phase 1/2 data showed Sanofi and GlaxoSmithKline's vaccine candidate spurred an adequate immune response in people aged 18 to 49 years—but the vaccine failed to trigger a comparable response in older adults. The setback triggered a new phase 2b trial and stands to delay the recombinant protein shot from mid-2021 to near the end of next year. The partners pegged insufficient concentrations of the adjuvant, supplied by Sanofi, as the likely cause of the lackluster data. They plan to launch a test of a new antigen formulation in February. Story
On the heels of Pfizer's panel review, the U.S. is planning to authorize the shot—which could go out to the public by Monday or Tuesday of next week, HHS secretary Alex Azar told ABC's Good Morning America. The FDA on Friday issued a statement saying "it will rapidly work toward finalization and issuance of an emergency use authorization" following Thursday's meeting.
Interim phase 1/2 data showed Sanofi and GlaxoSmithKline's vaccine candidate spurred an adequate immune response in people aged 18 to 49 years—but the vaccine failed to trigger a comparable response in older adults. The setback triggered a new phase 2b trial and stands to delay the recombinant protein shot from mid-2021 to near the end of next year. The partners pegged insufficient concentrations of the adjuvant, supplied by Sanofi, as the likely cause of the lackluster data. They plan to launch a test of a new antigen formulation in February. Story
By year-end, AstraZeneca plans to kick off a trial combining its vaccine with Russia's Sputnik V shot, the Russian Direct Investment Fund said. The hope is that by combining the two adenovirus vaccines, AstraZeneca's candidate—troubled in recent weeks by less-than-stellar data—could enjoy an efficacy boost. Meanwhile, Russia said it wants to jointly produce the new vaccine if it passes muster in the clinic.
Australia's CSL put the kibosh on mid- and late-stage trials of a vaccine in development with the University of Queensland after the shot triggered an antibody response that led to false positives on some HIV tests, the company said. Instead, CSL has signed on to manufacture another 20 million doses of AstraZeneca's vaccine on top of the 30 million doses it's already agreed to crank out. Plus, the company said it will still keep its phase 1 vaccine trial going.
Rumors that Pfizer and BioNTech's mRNA vaccine could cause infertility in women flooded social media this week—but that simply isn't true, health experts told The New York Times. A blog post compared the virus' spike protein with a type of placental protein, which it alleged were similar enough to trick the body into attacking the placenta. But those proteins are almost nothing alike, an expert in maternal and neonatal immunity at Duke University told the Times. Pfizer, meanwhile, pointed to a recent study showing its vaccine didn't appear to raise the risk of pregnancy-related problems.
UPDATED: Thursday, Dec. 10 at 3:25 p.m. ET
The U.S. could meet its goal to vaccinate every American by summer if it backs up its Pfizer and Moderna doses with vaccines from AstraZeneca and Johnson & Johnson, Warp Speed chief Moncef Slaoui said. Phase 3 data on the companies' viral vector vaccines are expected by February, he said, voicing confidence that both would succeed. The shots' proven technology would make them easier to scale up than mRNA candidates, too, Slaoui added. AZ and J&J are expected to provide between 150 million to 200 million doses total in 2021's first quarter. Story
Moncef Slaoui played matchmaker in Merck's recent $425 million buyout of OncoImmune, Bloomberg reports. The company is developing a non-antiviral immunomodulator, CD24Fc, which has shown promise in patients hospitalized with severe COVID-19. After seeing positive data on the drug, Slaoui quickly phoned OncoImmune's CEO and, two days later, Operation Warp Speed met with the company's research team. Slaoui then sent out a slate of emails to pharma execs—hooking Merck's research head, Roger Perlmutter.
The FDA cleared LabCorp's Pixel test for home use without a prescription. Self-collection kits can now be bought directly through the company's website by anyone over the age of 18 for the price of $119 out-of-pocket. After swabbing the the inside of the nose, the sealed sample is shipped overnight to a lab for analysis, with results typically delivered within one to two days. LabCorp will also use its online portal to connect users who test positive with a healthcare provider, supporting treatment and isolation. Story
CDC official Charlotte Kent, who edits the agency's Morbidity and Mortality Weekly Report, told House Democrats she was ordered to destroy an email from a Department of Health and Human Services staffer who tried to meddle in the report's publication. Kent's allegation stems from an August email from then-senior HHS adviser Paul Alexander, who asked her to put new language into an earlier report on COVID-19 risks to children or “pull it down and stop all reports immediately.”
In some 70 developing nations, only one in 10 people is expected to receive a COVID-19 vaccine next year, the People's Vaccine Alliance warned, urging drugmakers to share the science and technology behind their shots. Meanwhile, rich countries representing just 14% of the world's population have snapped up more than 50% of the leading shot candidates, The New York Times reports, citing data from the London-based software company Airfinity, which looked at supply deals covering eight vaccines in phase 3 testing.
Brazil's Sao Paulo state on Thursday started producing Sinovac's COVID-19 vaccine hopeful, Governor João Doria said. The state's Butantan Institute has capacity for 1 million doses of CoronaVac per day, he said. Sao Paulo plans to kick off vaccination efforts on Jan. 25, despite President Jair Bolsonaro's repeated objections to the Sinovac shot. Meanwhile, the country's health minister Thursday pledged to vaccinate Brazil's entire population against COVID-19 in 2021.
UPDATED: Thursday, Dec. 10 at 9:36 a.m. ET
Moderna dosed the first teenagers in a 3,000-subject, phase 2/3 trial to see whether its mRNA shot works in that age group. Moderna aims to deliver that data by spring 2021, hoping for an expanded approval ahead of the school year. The study's size and the low rate of symptomatic COVID-19 in adolescents may hinder Moderna's efforts to deliver data in time, though. Story
The brouhaha surrounding Warp Speed's Pfizer vaccine purchase continues. The government expects to receive all of its initial order by March, and it still has the option to purchase another 500 million doses after that, HHS Secretary Alex Azar told PBS Newshour. But former FDA commissioner and Pfizer board member Scott Gottlieb maintains that government "multiple times" turned down offers to purchase more shots than it did initially and may have missed its chance to secure another order before July, Gottlieb told CNBC.
Meanwhile, documents linked to Pfizer's vaccine submission in Europe were unlawfully accessed in a recent cyberattack targeting the European Medicines Agency. Neither Pfizer nor BioNTech's own systems was breached, and as far as the companies know, no trial participants were ID'd. The attack should have no bearing on the timing of the partners' vaccine review, the companies added. Story
Plus, the FDA's vaccine advisory committee takes its deep dive into Pfizer and BioNTech's mRNA shot Thursday and weigh in by day's end on whether the FDA should issue an emergency green light. Meanwhile, the CDC's Advisory Committee on Immunization Practices will meet Friday and Sunday to hash out who should receive the first doses.
AstraZeneca's shot has a "distinct comparative advantage" over its rivals, Richard Horton, editor-in-chief of The Lancet, said. For one thing, it can be easily stored and distributed across low- and middle-income countries, he figures. Unlike Pfizer's shot, which must be kept at minus 94 degrees Fahrenheit, AZ's vaccine can be stored at regular refrigerator temps. Plus, Horton said, it's cheaper than its rivals.
Rudolph Giuliani, personal lawyer to President Donald Trump and the latest member of his inner circle to test positive for COVID-19, was treated with Eli Lilly's monoclonal antibody bamlanivimab and Regeneron's antibody cocktail, he told WABC radio. Meanwhile, across the nation, antibody treatments are so scarce that states have developed systems for rationing their use, The New York Times reports.
South Africa will leverage rolling reviews to fast track approval of COVID-19 vaccines, the country's drug regulator, SAHPRA, told Reuters. It expects to receive its first set of applications within two weeks and hopes to receive its first doses from the World Health Organization's COVAX distribution scheme in the second quarter of 2021.
UPDATED: Wednesday, Dec. 9 at 3:03 p.m. ET
Canada Wednesday became the third country to authorize Pfizer and BioNTech's mRNA vaccine, paving the way for a shot rollout as early as next week. Pfizer will supply Canada with up to 76 million doses of its vaccine, a spokeswoman for the drugmaker's Canadian unit said. On Monday, the country said it had secured early delivery of 249,000 initial doses in anticipation of vaccination efforts next week.
The European Medicines Agency said Wednesday it had been hit by a cyberattack. It's unclear who was behind the attack or what, if any, data were compromised, though the cybersecurity scare comes as the EMA weighs approvals for vaccines from Pfizer, Moderna and AstraZeneca. Earlier this month, The Wall Street Journal reported that North Korean hackers had targeted AZ, Johnson & Johnson and Novavax, as well as three South Korean drugmakers working on COVID-19 meds.
President-elect Joe Biden aims to get 100 million Americans vaccinated during his initial hundred days in office—and that's just the first piece of a three-part plan to overhaul the nation's pandemic response. Biden also intends to sign a mask mandate and hopes to safely reopen the majority of American schools by the end of his first 100-day run.
As the country slaps together a piecemeal shot distribution plan, states are disagreeing on which workers qualify as essential. More than 20 industry groups representing truck drivers, teachers, retail workers and more are pushing officials to prioritize their employees. States are largely following federal guidance to protect workers in the food and meat processing industries, but some are awaiting further guidance from the CDC's Advisory Committee on Immunization Practices.
The San Francisco Bay Area is gearing up to start vaccinations as early as next week—contingent on Pfizer's shot winning a speedy authorization from the FDA, the San Francisco Chronicle reports. The city's Department of Public Health expects to receive some 12,000 initial doses out of the 2.1 million set aside for California. Across the state, vaccines will first go out to healthcare employees, long-term care facility residents, first responders and dialysis workers.
Revving up for a mass vaccination program, Indonesia on Sunday received its first, 1.2 million-dose vaccine shipment from China's Sinovac, the country's president said. The government plans to grab another 1.8 million doses in January and is awaiting shipments of raw materials to crank out 15 million doses this month, followed by materials for 30 million more doses in January, he added. Indonesia, which hasn't yet authorized the vaccine, started testing the shot in August.
UPDATED: Wednesday, Dec. 9 at 9:15 a.m. ET
Roche is teaming up with Moderna to include its Elecsys Anti-SARS-CoV-2 S antibody test in the biotech's vaccine trial. Moderna will use the test to measure the immune response triggered by its mRNA shot. By providing a quantitative readout of antibody levels, the test could also help determine when or whether a patient needs revaccination, Roche figures. Story
People with a history of allergic reactions should not get Pfizer's COVID vaccine, the U,K,'s drug regulator said. The advice came after two National Health Service (NHS) staffers reported anaphylactoid reactions linked to taking the vaccine, Reuters reports. Both are recovering well, NHS medical director Stephen Powis said. Pfizer said it's supporting the country's Medicines and Healthcare Products Regulatory Agency as it seeks further information on the reactions.
Meanwhile, four patients in Pfizer's late-stage vaccine study experienced facial paralysis, prompting the need for further observation once the shot becomes widely available, the FDA said. No participants in the control group developed Bell's palsy, though the frequency of cases was “consistent with the expected background rate in the general population,” the FDA said. Story
AstraZeneca's vaccine could work at a single dose and prevent asymptomatic cases, but key efficacy questions remain after full late-stage data were published in The Lancet. The rate of asymptomatic infection in patients who received AZ's half-dose primer shot landed at 0.6%, compared to 1% in the full two-dose group. But trial protocols diverged greatly between sites, with patients in the U.K. and Brazil often receiving their second doses at different intervals in the study. That could affect efficacy if lag time between the prime and booster shot matter. Story
Sinopharm's experimental COVID-19 vaccine is 86% effective, the health ministry of the United Arab Emirates said, citing interim phase 3 data. UAE kicked off a late-stage trial of the shot in July. In September, it cleared the vaccine for emergency use in certain groups. Meanwhile, the state added that it had officially registered the shot, without clarifying whether that meant it had authorized the vaccine for wider use.
At least 110,000 doses of Pfizer and BioNTech's vaccine are expected to arrive in Israel Wednesday, with a slate of medical workers already in line to receive the first batch, The Jerusalem Post reports. The country has purchased 8 million doses from Pfizer and could see 4 million of those arrive before year-end, though the country will wait for the shot to snare U.S. FDA approval before giving it to the public, Chezy Levy, director-general of the Israeli Health Ministry, said.
Plus, Israeli Prime Minister Benjamin Netanyahu will be the first person in the country to receive Pfizer's vaccine, BNN Bloomberg reports. “I believe in this vaccine, I expect it to get the necessary approvals in the next few days,” Netanyahu said, adding that he wanted to set an example for other Israelis to get vaccinated.
UPDATED: Tuesday, Dec. 8 at 2:45 p.m. ET
Pfizer and BioNTech's mRNA vaccine starts to protect against COVID-19 after the first dose, according to FDA documents published ahead of Thursday's advisory panel meeting. The briefing docs reiterated that the shot was 95% effective after two doses. Efficacy was consistently high at 94.7% for participants over the age of 65 and 95.3% in those with underlying conditions. Story
AstraZeneca's vaccine is safe and effective at preventing COVID-19, researchers writing for The Lancet confirmed. Average efficacy landed at 70.4%, according to pooled data on 11,636 trial subjects from the U.K. and Brazil. As AZ previously revealed, a half-dose primer shot—originally given to patients by mistake—led to 90% efficacy, while the full two-dose course was 62.1% effective. Meanwhile, the British pharma has started submitting data to regulators and its supply chains are primed and ready to deliver hundreds of millions of doses globally, CEO Pascal Soriot said.
Speaking of supply chains, AstraZeneca tapped Dutch CDMO Halix to carry out large-scale commercial drug substance manufacturing for its University of Oxford-partnered vaccine. Halix will perform the work from its facility at the Leiden Bio Science Park in the Netherlands, the company said in a release. The CDMO was one of the original partners in Oxford's consortium to manufacture the shot, Halix added.
NeuroRx and Relief Therapeutics hit the enrollment target for a phase 2b/3 trial of their drug RLF-100, also known as aviptadil, in patients with COVID-19 respiratory failure. The drug has an FDA OK to test intravenous and inhaled versions of the therapy and snared a fast track tag, too.
An agency watchdog cleared the U.S. International Development Finance Corporation (DFC) of fault in its plan to grant Kodak $765 million to enter drug manufacturing. In a copy of the review obtained by The Wall Street Journal, the agency's inspector general couldn't find "any evidence of misconduct" by DFC officials, though he did take issue with the timing of the loan's announcement. Story
California on Monday became the largest state to roll out Google and Apple's contact tracing tech for smartphones. The app lets users' devices communicate anonymously via Bluetooth and sends a tip to users when a recent contact tests positive.
India is weeks away from a vaccine approval, the country's federal health secretary said. Pfizer and AstraZeneca—by way of the Serum Institute of India—both filed their shots for an Indian OK over the weekend, while domestic shot maker Bharat Biotech has also submitted its candidate, Covaxin, to regulators.
UPDATED: Tuesday, Dec. 8 at 9:20 a.m. ET
The U.K., which kicked off its vaccination drive Tuesday, is plotting a "mix and match" trial of Pfizer and AstraZeneca's COVID-19 shots to see whether the vaccines work better as a team. The trial is pegged to start in January after AZ's shot wins a regulatory OK. Moderna's mRNA vaccine will also be thrown into the mix if it's cleared by U.K. regulators, too, Kate Bingham, head of the country's vaccine taskforce, said.
The U.S. is capped at the 100 million doses it already ordered from Pfizer until at least next June, The New York Times reports. During the supply deal's early days, Pfizer urged Operation Warp Speed to purchase an initial 200 million doses, enough to vaccinate 100 million people, but officials rejected that offer, sources told The Times. Just recently, the U.S. approached Pfizer for additional doses, but the drugmaker explained supplies had been snapped up by other countries. Story
Which are the top 10 manufacturers in the fight against COVID-19? Already a booming industry before the pandemic, the contract manufacturing field has taken off this year as drugmakers look to scale up production and lean on specialized knowledge to get their vaccines and meds to potentially billions of patients. Fierce Pharma's special report shows how companies such as Emergent, Serum Institute of India, Fujifilm and Phlow are pitching in. Story
The U.S. has the option to buy another 500 million Pfizer doses, Department of Health and Human Services Secretary Alex Azar reminded NBC News, but it may not be that simple. When the government passed on a larger dose order in July, Pfizer went on to ink a slate of multimillion-dose deals with the likes of Canada, the U.K. and the European Union. Now, supplies are limited, and “any additional doses beyond the 100 million are subject to a separate and mutually acceptable agreement,” the drugmaker said.
Meanwhile, The New York Times' take on the government's Pfizer order is "false," a Trump administration official told CBS News. The administration is "in the middle of negotiations right now and can't talk publicly about it," but feels confident that every American who wants a vaccine will get one, the official said.
Plus, Canada will start receiving doses of Pfizer's vaccine this week, with up to 249,000 doses expected by the month's end, Prime Minister Justin Trudeau said. If the country's drug regulator authorizes the shot this week, Canadians could start receiving vaccinations as early as next week.
Pfizer and Moderna won't attend an upcoming White House summit meant to build confidence in vaccines, Bloomberg reports. Operation Warp Speed had originally extended an invite to several shot developers, but once a Peter Marks presentation showed up on the docket, a decision was made to keep drugmakers separate from their regulator, the news outlet said. Marks heads up the FDA center that reviews vaccines.
The FDA Tuesday released a detailed analysis of Pfizer and BioNTech's vaccine to lay the groundwork for Thursday's emergency authorization review—one from the FDA's own staff and scientists, and another from the companies themselves.
Don't throw out your masks once a vaccine is approved. While the shots from Pfizer and Moderna appear effective at preventing serious illness, the jury's still out on whether they curb the virus' spread, health experts told The New York Times.
UPDATED: Monday, Dec. 7 at 3:18 p.m. ET
President-elect Joe Biden tapped California Attorney General Xavier Becerra as his choice for Department of Health and Human Services Secretary, according to multiple reports. While the current Secretary Alex Azar—a former Eli Lilly exec—is seen as a friend to pharma, his replacement looks more like a critic. Early into his AG post, Becerra joined 39 other states in a federal antitrust lawsuit that accused six generic drugmakers of colluding in a price-fixing scheme. He's also led California's legal battle against Purdue Pharma for its role in the opioid crisis. Story
The FDA Friday approved its first at-home test kit that can detect COVID-19, plus influenza A and B. Developed by Quest Diagnostics, the test allows patients with signs of respiratory infection to collect a nasal sample and send it off to the company's labs to differentiate between the viruses and seek appropriate care. Available by prescription, the test is intended for those over the age of 18, while adolescents and children can be swabbed with adult supervision. Story
Qiagen rolled out a new blood test to detect the activity of T-cells, which studies have shown may provide longer-term protection against the coronavirus than antibodies, the diagnostics maker said. There's evidence to suggest T-cell responses may help predict disease severity and potential protection in COVID-19 patients post-recovery, too. Last month, Qiagen forged a COVID-19 pact with TScan Therapeutics to use the company's genome-based, high-throughput discovery platform for T-cell receptors to develop new in-vitro lab tests. Story
Researchers in California aim to develop a CRISPR-based COVID-19 test that runs on a smartphone and delivers results in less than 30 minutes. Most current molecular tests for the disease are based on PCR, which requires the virus’ RNA to be converted into DNA and then amplified. The researchers' approach, meanwhile, uses CRISPR proteins designed to hunt directly for the virus’ RNA, skipping those steps for swifter results. Story
Backed by an army of healthcare workers and tens of thousands of volunteers, the U.K. on Tuesday will start vaccinating the public with Pfizer and BioNTech's COVID-19 shot—with the goal to vaccinate more than 20,000 citizens in a few months time, The New York Times reports. Under the umbrella of the country's National Health Service, family doctors will be tasked with doling out many of the shots. Meanwhile, the country is setting up temporary vaccination sites and recruiting retired health care workers to see the massive effort through.
Meanwhile, Moscow on Saturday started distributing Russia's Sputnik V vaccine through 70 clinics, with the aim to get shots to the country's most exposed groups, Reuters reports. The vaccine, developed by the country's Gamaleya Institute, will first got out to healthcare workers, teachers and social workers. The age to receive a vaccine is capped at 50. Those with underlying health conditions, pregnant women and those who've had a respiratory illness for the past two weeks are ineligible, the news outlet wrote.
AstraZeneca's Chinese manufacturing partner for its COVID-19 vaccine, Shenzhen Kangtai, isn't immune to the corruption that's plagued many of the country's drugmakers, The New York Times reports. A government official was jailed in 2016 for taking bribes from Shenzen's chairmen, Du Weimin—known in some circles as the "king of vaccines." Meanwhile, a former head of the Gates Foundation vouched for Shenzen's vaccine know-how, but critiqued its business practices, suggesting that to sell to local governments, "they have to do kickbacks, they have to bribe.”
Canada's AbCellera, tapped by Eli Lilly earlier this year to find the human antibody behind its recently-authorized COVID-19 drug bamlanivimab, plans to raise a hefty $357 million on the Nasdaq by offering 23 million shares at a price range of $14 to $17, with the company valued at the midpoint range at around $5 billion. The company, which uses AI to speed up drug research, in March got off a $105 million series B, partially funded by Lilly. In May, the company snared $175.6 million in support from the Canadian government. Story
UPDATED: Monday, Dec. 7 at 9:35 a.m. ET
Ahead of Pfizer's vaccine review this Thursday, Moncef Slaoui, head of the government's Operation Warp Speed vaccine program, plans to meet with President-elect Joe Biden to discuss the Trump administration's distribution scheme. Biden says he's yet to see a detailed outline of the plan, which he called expensive and difficult. Slaoui, for his part, told CBS' Face the Nation that the government's distribution effort is "very appropriately planned."
If FDA commissioner Stephen Hahn were to issue an emergency use authorization for Pfizer's vaccine candidate Thursday—the same day a panel of FDA advisers will meet to assess the shot—Americans could start receiving the vaccine in as little as 24 hours, James Hildreth, a member of the agency's Vaccines and Related Biological Products Advisory Committee, told NBC. Meanwhile, "the minute it's approved, the shipments will start," Slaoui said.
It may be time to start scaring people about COVID-19, a New York Times op-ed argues. Much in the same way antismoking "scare" campaigns helped smoking rates plummet in the late 1960s and early 1970s, graphic reminders of COVID's physical toll could offer some perspective on the costs of catching the virus. California has come closest in one recent PSA—a soft-focus video featuring the sounds of a person on a ventilator, with a voiceover appeal to mask up for the benefit of friends and family.
Bahrain, located in the Persian Gulf, became the second nation after the U.K. to approve Pfizer and BioNTech's mRNA vaccine, a state-run news agency announced Friday. Both Pfizer and Bahrain are keeping details on the volume and timing of the country's vaccine order close to the vest. The country previously authorized a shot from China's Sinopharm and has so far vaccinated around 6,000 people.
Pfizer on Friday became the first company to seek emergency approval for a coronavirus vaccine in India. The country expects to have a vaccine available in the next few weeks and will kick off vaccinations as soon as a green light is granted, Prime Minister Narendra Modi said.
Meanwhile, Serum Institute of India on Monday filed for an emergency use authorization of AstraZeneca's vaccine there, CEO Adar Poonawalla tweeted. The app made SII the second company after Pfizer to apply for a vaccine nod in-country, though AZ's shot may be better suited to Indian distribution because it can shipped and stored at refrigerator temperatures.
Plus, India is speeding up reviews of AstraZeneca and Pfizer's vaccine candidates, a government official said Monday. Serum Institute, producing AstraZeneca's shot under the name Covishield in India, recently said it planned to continue testing two full doses of the vaccine after AZ revealed a half-dose primer shot might work better. With about 40 million doses already on hand, Serum Institute will first supply the Indian government, but then plans to sell 20 million to 30 million doses to private facilities there as early as March, Poonawalla told the Financial Times. The company will focus on Indian supplies before marketing the shot in other countries, pricing it at 1,000 rupees ($13.50) per dose for private markets, Poonawalla said.
Sinovac bagged $515 million from fellow Chinese firm Sino Biopharmaceutical to double capacity for its COVID-19 vaccine hopeful, CoronaVac. Sinovac expects to have capacity for 300 million doses per year, though it plans to wrap construction on a second production facility before the end of 2020 that would bump up its annual volume to 600 doses. The company has so far sold doses to Turkey, Brazil and Chile, and is in talks with the Philippines on a potential supply deal. Story
UPDATED: Friday, Dec. 4 at 3:15 p.m. ET
Antibody levels stayed elevated in the 90 days after patients received a second dose of Moderna's vaccine candidate, updated phase 1/2 data show, raising hopes that the vaccine could offer longer-term protection. Researchers noted a slight drop in binding and neutralizing antibodies over the period, though the average levels for both antibody types remained above the median of a panel of 41 recovered COVID-19 patients. Story
Pfizer is expected to provide enough initial shot doses for 3.2 million Americans if it wins clearance from the FDA—not nearly enough for the country's 21 million healthcare workers, Reuters reports. Complicating matters further, those first doses are slated for delivery to five government agencies, officials have said. After that, vaccine distribution could cover 7 million to 10 million people per week, assuming Moderna's shot gets a thumbs up in the second half of December and Pfizer meets its estimates for followup deliveries, the news outlet predicts.
With the pandemic ushering in an industrywide pivot to digital, Omnicom Group's Tribal Worldwide is spinning out a new pharma specialty unit, Tribal Health, to help clients grapple with virtual realities of the modern age. Current Tribal clients GlaxoSmithKline and Gilead are among those moving to the new unit's roster. Meanwhile, boots-on-the-ground sales reps won't disappear completely—they'll just become more digitally-focused, Jason Galla-Barth, a managing partner at Tribal who will lead Tribal Health, said. Story
Sales of Everlywell's at-home diagnostics, including a kit for COVID-19, are expected to quadruple this year. Investors have taken note, helping the company raise $175 million in its second venture capital funding round this year. Everlywell will use the cash to boost telehealth offerings, focusing on routine diagnostic tests to help manage chronic disease and track care in clinical trials. The company in February bagged an FDA emergency nod for its swab-based home collection kit, which users can ship to labs overnight for analysis with a range of tests. Story
Meanwhile, at-home saliva tests could offer a salve to the high demand and slow turnaround for swab-based diagnostics, The New York Times reports. Recently, more communities across the U.S. have started rolling out do-it-yourself spit tests. In Minnesota, for instance, at-home testing kits are typically shipped within 24 hours after an order is placed. Users are guided through the sample collection process with a healthcare worker over Zoom, and once samples are shipped to a lab, results are delivered in one to two days.
The White House could realistically achieve its goal of vaccinating 20 million Americans before year-end, FDA Commissioner Stephen Hahn told Reuters. Earlier this week, Hahn met with chief of staff Mark Meadows in what he called a "robust" discussion about vaccine approval timelines. To hit the Trump Administration's vaccination goal, the FDA would need to clear both Pfizer and Moderna's shots—slated for review on Dec. 10 and Dec. 17, respectively—within the month.
Meanwhile, Stephen Hahn took to Twitter Friday to help demystify the regulator's vaccine application review process.
#Vaccines101: FDA evaluation of a vaccine application includes assessing the data and the product, its quality and safety, and the technology to manufacture it. #FDAVaccineFacts https://t.co/uxcPWmhbrM— Dr. Stephen M. Hahn (@SteveFDA) December 4, 2020
Lexaria Bioscence published preclinical data showing its DehydraTECH platform—designed to improve oral delivery of antiviral drugs—could successfully deliver HIV meds from Johnson & Johnson and Bristol Myers Squibb in rats. Using the study as a launchpad, Lexaria in January plans to start testing the technology on antivirals used to treat HIV and COVID-19. Story
UPDATED: Friday, Dec. 4 at 9:19 a.m. ET
Once a COVID-19 shot snares approval, the next challenges will be rapid-fire production and equitable distribution across the U.S., top executives from Johnson & Johnson, Moderna and Pfizer told NBC. Access to vaccines in Black and Hispanic communities, which have been hit especially hard by COVID-19, is one major concern, J&J chief Alex Gorsky said. Meanwhile, Pfizer CEO Albert Bourla, M.D., said his company is working with regulators to find a way to vaccinate trial participants who received placebo, calling the move an "ethical dilemma and obligation." Story
NIAID Director Anthony Fauci, M.D., will keep his post under President-elect Joe Biden and will also serve as chief medical adviser to the White House, The New York Times reports. Biden also asked the nation's top infectious disease expert to join his COVID-19 team—an offer Fauci said he accepted "right on the spot." Fauci has been sidelined by President Donald Trump in recent months as the two allegedly sparred over use of masks, the pandemic's trajectory and more.
Pfizer set the record straight on a Thursday report from The Wall Street Journal stating raw material shortages would cut the drugmaker's 2020 vaccine output from 100 million doses to 50 million doses. The information is correct, but outdated, a company spokesperson told Barron's. Pfizer on Nov. 9 announced it would scale back its 2020 production target, weeks before WSJ's report, and has used the updated figures in its public forecasts since. Story
Clover Biopharmaceuticals' protein-based S-Trimer vaccine candidates, in combination with adjuvants from either GlaxoSmithKline or Dynavax, triggered a safe and effective immune response in a 150-subject phase 1 study, the company said. Testing showed the vaccines were stable for six months at fridge temps of between 2 and 8 degrees Celsius (35.6 and 46.4 degrees Fahrenheit) and could last up to a month at room temperature, potentially easing future distribution. A phase 2/3 trial with GSK's adjuvant is slated to kick off in December, with a separate Dynavax adjuvant trial to follow in 2021. Story
Rich countries have cornered global supply of COVID-19 vaccines, suggesting low-risk people in nations like the U.S. will likely be immunized before high-risk people in poorer countries, NPR reports. The U.S. leads the pack with 2.6 billion potential doses locked down, followed by the EU with 2 billion prospective shots and India at 1.6 billion. Meanwhile, when shots become widely available next year, the U.S. will likely have enough doses to vaccinate its entire population twice over.
A blood test could help predict efficacy of coronavirus vaccines and pave the way for easier study of next-generation shots, a monkey trial published in Nature found. The study found telltale blood markers that predict whether a monkey's immune system is equipped to fight off the virus, raising hopes that researchers could look for those same markers in human vaccine trials.
UPDATED: Thursday, Dec. 3 at 3:24 p.m. ET
The pandemic has at times created huge surges in demand for medical supplies such as personal protective equipment and testing supplies. Now, with vaccines nearing potential rollouts, dry ice is becoming a crucial commodity to help keep the shipments cold, The Wall Street Journal reports. Companies involved in making dry ice expect to have a busy December, the newspaper reports.
With billions of vaccinations expected in the coming years, Becton Dickinson is gearing up to meet demand for prefilled syringes. The company is spending $1.2 billion on a new production site in Europe and investing in other existing facilities. Story
Inovio, aiming to boost potential capacity for its INO-4800 vaccine, inked a production deal with Kaneka Eurogentec. Specific details weren't disclosed. Inovio's program is in phase 2 testing, and while the company released interim phase 1 results, it has not released a full phase 1 readout. Release
UPDATED: Thursday, Dec. 3 at 9:35 a.m. ET
Results from AstraZeneca's late-stage U.S. vaccine trial will likely roll in by late January, Operation Warp Speed chief Moncef Slaoui, M.D., said. That's important, because the large set of contrasting data from trials in the U.K. and Brazil may not be enough to convince the FDA to grant the British drugmaker an emergency nod, Slaoui said. AZ recently reported that its vaccine was 90% effective when given as a half-dose primer followed by a full-dose booster, while the intended two-dose regimen charted efficacy around 70%.
An editorial in The New England Journal of Medicine is challenging a large, WHO-run trial that found Gilead's antiviral Veklury, also known as remdesivir, did little to improve COVID-19 survival. Among the issues raised? WHO's trial took place across 30 countries, fueling inconsistencies in the data collected. Plus, the study researchers did not collect or record standard of care or healthcare capacity in any of the 400 hospitals tapped for the trial.
Former U.S. Presidents Barack Obama, George W. Bush and Bill Clinton all volunteered to roll up their sleeves for a COVID-19 vaccine—and they're willing to do it on camera to help persuade the public the shot is safe, CNN reports. Obama said he would feel confident in a vaccine endorsed by NIAID Director Anthony Fauci, though he acknowledged that some Black Americans might be more hesitant to get the shot because of historical racism in the healthcare system.
Meanwhile, Fauci, the U.S.' top infectious disease expert, slammed the U.K. for its speedy authorization of Pfizer and BioNTech's vaccine. “If you go quickly and you do it superficially, people are not going to want to get vaccinated,” Fauci told Fox News. The U.K. did not review its shot as carefully as the FDA plans to do, he said. "They got a couple of days ahead. I don’t think that makes much difference."
England's National Health Service and Medicines and Healthcare products Regulatory Agency are scrambling to figure out how to deploy Pfizer's vaccine, which must be stored at a frigid minus 94 degrees Fahrenheit, in care homes, Reuters reports, citing deputy Chief Medical Officer Jonathan Van-Tam. There;s "no absolute assurance" the U.K. can get the shot to those residents, Van-Tam said, arguing, "one thing we can’t do is … end up with a vaccine that’s been handled incorrectly, and then isn’t properly viable at the end of the distribution chain.”
Pfizer is committed to working with the Indian government to make its vaccine available in-country, the Hindustan Times reports, citing a company spokesperson. Back in November, V K Paul, who heads the country's COVID-19 task force, warned it might take months for Pfizer's shot to arrive in India, with cold chain arrangements the biggest hurdle the nation needs to overcome.
Sanofi and GlaxoSmithKline plan to announce the price of their COVID-19 vaccine candidate upon the release of phase 1/2 trial results, expected before the end of the month, Thomas Triomphe, vaccines chief at Sanofi, said Thursday.
South Korea on Friday inked a deal to import doses of AstraZeneca and the University of Oxford's vaccine hopeful, public health authorities said. The government will hammer out the specific dose count and delivery timeline at a later date. Meanwhile, South Korea has also signed a memorandum of understanding with Johnson & Johnson and Pfizer.
IBM says it has uncovered a "global phishing campaign" targeting organizations focused on the COVID-19 vaccine cold chain. The report was reposted by The U.S. Cybersecurity and Infrastructure Security Agency in a warning to members of Operation Warp Speed. Bogus emails were sent to roughly 10 different organizations, with the European Commission’s Directorate-General for Taxation and Customs Union the only group IBM cited by name.
Meanwhile, North Korean hackers are targeting vaccine makers Johnson & Johnson and Novavax, as well as South Korean drugmakers Genexine, Shin Poong Pharmaceutical and Celltrion—all running earlier-stage trials of COVID meds, The Wall Street Journal reports, citing sources close to the matter. Meanwhile, Reuters reported Friday that North Korean hackers had attempted to breach AstraZeneca's systems, too. It's unclear whether the hackers purloined any information.
UPDATED: Wednesday, Dec. 2 at 3:17 p.m. ET
A quintet of top vaccine makers are set to split around $38.5 billion in sales next year—and Pfizer, freshly armed with a U.K. approval, is in line for a $14.3 billion slice of the pie, Bernstein analysts figure. Moderna should expect to reap $10.9 billion, followed by $6.4 billion for AstraZeneca, $3.9 billion for Novavax and $3 billion for Johnson & Johnson. The analysts further predicted $23.1 billion in total vaccine sales in 2022, $12.6 billion in 2023 and $8.5 billion in 2024 before the market settles at around $6 billion in 2025. Story
Merck & Co. on Tuesday said it had divested its stake in Moderna, fueling "a small fourth-quarter gain." It's unclear how much Merck stands to make, but it's likely to be significant: Moderna went public in December 2018 at a price of $23 per share, while Tuesday's closing price was $142. Merck first pumped $100 million in cash and stock into Moderna in 2015 to partner on five preclinical mRNA projects, later investing another $125 million in 2018. Story
The Trump Administration aims to vaccinate 100 million people by February—enough to cover all healthcare workers and the country's at-risk population, Operation Warp Speed (OWS) officials said Wednesday. Twenty million people are expected to get a shot by year-end, followed by 30 million people in January and another 50 million by February, Warp Speed chief Moncef Slaoui said. Story
Roche got a thumbs up from the FDA for its Elecsys quantitative antibody test, a more accurate blood test able to measure the levels of specific antibodies that target the coronavirus’s spike protein. The test could help weigh the efficacy of vaccines and ID recovered patients with potential to serve as convalescent plasma donors, the company said. Running on Roche's cobas e analyzers, the test provides a result in about 18 minutes. Story
Nova Scotia, Canada-based drugmaker Appili Therapeutics on Wednesday said investigators had dosed the first patient in a phase 3 trial assessing Fujifilm's flu med Avigan, also known as favipiravir, in COVID-19. One of three Appili-run Avigan trials, the so-called Preseco study will test whether the drug can alleviate symptoms and prevent disease progression in patients with mild to moderate COVID-19. The study will look to enroll 826 subjects, with early results expected in the first half of 2021, Appili said.
Move over hackers: Organized criminal networks could be the latest group to target COVID-19 vaccines, and they may even look to sell counterfeit shots, the international police organization Interpol warned Wednesday. "[Criminal organizations] are planning to infiltrate or disrupt supply chains," Interpol's secretary general said in a warning to the agency's 194 member countries. "Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures."
The European Union is none too pleased with the U.K.'s rapid fire authorization of Pfizer and BioNTech's vaccine, Reuters reports. Through an emergency approval process, the U.K.'s drug regulator was able to temporarily OK the shot only 10 days after starting its review of data from large-scale trials. The European Medicines Agency argued its longer approval process is better suited to the task, because it calls for more data and involves more checks than the U.K.'s emergency procedure.
On orders from President Vladimir Putin, Russia will kick off a voluntary mass vaccination campaign next week, with teachers and doctors likely among the first to receive the shot. The country will have produced 2 million vaccine doses within the next several days, Putin added. Russia has already vaccinated more than 100,000 high-risk people with its Sputnik V vaccine, the country's health minister said during a United Nations presentation on the shot.
UPDATED: Wednesday, Dec. 2 at 9:03 a.m. ET
The U.K.'s Medicines & Healthcare Products Regulatory Agency Wednesday doled out an emergency use authorization for Pfizer and BioNTech's vaccine. The U.K. has a contract for 40 million doses. Shipments are expected to start rolling in immediately, and shots will be made available across the country starting next week. Meanwhile, Pfizer's shot is due for a Dec. 10 advisory committee review in the U.S. Story
The European Medicines Agency (EMA) on Tuesday kicked off a rolling review of Johnson & Johnson's recombinant vector vaccine candidate. The hastened process will allow Europe's health regulator to assess J&J's shot in real time as data trickles in. The EMA previously initiated rolling reviews on shots from AstraZeneca, Moderna, and Pfizer and BioNTech.
Serum Institute of India will continue testing a full two-dose regimen of AstraZeneca's vaccine—despite a recent data reveal showing an initial half-dose primer might spark greater efficacy. At two full doses, AstraZeneca's shot proved 62% effective in phase 3, well below the figures presented by Pfizer and Moderna. That said, “Anything which is beyond 50% is always going to be a plus," Suresh Jadhav, an executive director at SII, told Reuters. He added that changing dosing now would also delay trials.
The CDC's Advisory Committee for Immunization Practices (ACIP) voted 13-1 Tuesday to recommend healthcare workers and long-term care residents get first dibs on an authorized COVID-19 vaccine. ACIP also recommended vaccinating nursing home staffers alongside residents. The committee is due to meet again after a Dec. 10 advisory committee review of Pfizer's shot hopeful, where it will vote to recommend whether an authorized shot should go out to the public.
While the leading slate of vaccines have been well-tested in adults, there's a dearth of information on how those shots might work in younger children. Now, pediatricians are urging drugmakers to step up their game. The American Academy of Pediatrics, for instance, has called on researchers to expand clinical trials to include children of all ages as soon as possible. Others argue that a vaccine that works in children is a critical step to reopening classrooms. Pfizer, for its part, started including children ages 12 and older in its trial this fall.
President Donald Trump has summoned vaccine manufacturers, drug distributors and government officials for a White House COVID-19 summit on Dec. 8, just days before planned reviews of Pfizer and Moderna's vaccine candidates. Industry officials aware of the plan painted the move as an opportunity for the White House to pressure the FDA to quickly issue emergency approvals for the shots. Pfizer and Moderna, plus companies like McKesson, Walgreens, CVS Health, Fedex and more are reportedly among those invited.
UPDATED: Tuesday, Dec. 1 at 3:19 p.m. ET
Regeneron tapped gene therapy pioneer Jim Wilson and the University of Pennsylvania to help deliver its antibody cocktail as a prophylactic nasal spray. The biotech's recently-authorized therapy is injected, but Regeneron and Penn aim to leverage Wilson's gene therapy expertise to attempt an intranasal formulation using adeno-associated virus (AAV) vectors. By introducing the therapy via single dose of AAV, Wilson's team thinks the drug could provide protection on par with Regeneron's cocktail, but “for potentially a longer duration.” Story
Amgen, Takeda and UCB kicked off an adaptive trial to see whether any one of a trio of drugs could curb the unchecked inflammatory response seen in some COVID patients. The trial will assess Amgen's psoriasis and psoriatic arthritis med Otezla; Takeda's IV formula of its hereditary angioedema therapy Takhzyro; and UCB's experimental autoimmune drug zilucoplan. The study will recruit a range of hospitalized patients, from those with mild disease to patients requiring ventilation or oxygen support. Story
Scott Atlas, pandemic adviser to President Donald Trump, resigned Monday. A neuroradiologist without an infectious disease or public health background, Atlas drew fire for suggesting the virus should be allowed to spread among young, healthy people to help the U.S. hit "herd immunity." Atlas allegedly sparred with fellow task force members Deborah Birx and Anthony Fauci over boosting testing efforts, too, and forwarded fringe theories about the ineffectiveness of masks and social distancing.
Only 10% to 15% of subjects in Pfizer and Moderna's late-stage vaccine trials reported "significantly noticeable" side effects, Moncef Slaoui, head of the Trump administration's Operation Warp Speed program, said. Participants hit with side effects reported pain at the injection site, fever, chills, muscle aches and headaches, with most reactions lasting up to a day and a half. While the short- and "mid-term" effects of the vaccines are now well known, longer-term safety "is not yet understood by definition," Slaoui cautioned.
The European Medicines Agency (EMA) said Tuesday that it plans to meet by Dec. 29 to weigh Pfizer and BioNTech's vaccine hopeful for a possible emergency approval, with a review for Moderna's mRNA-based candidate pegged for Jan. 12. Pfizer, which earlier Tuesday asked the European Union's drug regulator for a speedy review, now has a slimmer chance of rolling out its shot in the bloc before year-end, though the EMA said it could bump up the meeting date if data comes in quickly.
Meanwhile, Germany aims to start vaccinating vulnerable people and caregivers by January, health minister Jens Spahn told the German broadcaster Deutschlandfunk. The country is setting up special vaccination centers, pegged to come online in mid-December, to grapple with the cold storage requirements for Pfizer and BioNTech's shot, which must be kept at a frigid minus 94 degrees Fahrenheit. Spahn last month said he expected Germany to receive upward of 100 million doses of Pfizer and BioNTech's vaccine.
SAB Biotherapeutics bagged $57.5 million from the Biomedical Advanced Research and Development Authority and the Department of Defense to help manufacture its experimental polyclonal antibody, SAB-185. The antibody was developed using SAB's DiversitAb Rapid Response Antibody Program and is currently in a phase 1 trial in healthy volunteers and a phase 1b study in patients with mild to moderate COVID-19.
As the push to vaccinate looms, dentists and optometrists are seeking clearance to administer COVID shots during routine eye exams and teeth cleanings, NBC News reports. Professional organizations representing dentists and optometrists in California are in talks with state officials to expand their roles to include vaccination, while Oregon has already started training and certifying dentists to dole out shots. Meanwhile, at least half of U.S. states have considered deputizing dentists as vaccinators, according to the American Association of Dental Boards.
UPDATED: Tuesday, Dec. 1 at 8:45 a.m. ET
Having already filed their mRNA-based vaccine for emergency use in the U.S. and the U.K., Pfizer and BioNTech have now submitted the shot at the European Medicines Agency. The partners filed for the FDA's approval late last month after unveiling interim late-stage data showing their shot hit a 90% efficacy mark; a recent update boosted that number to 95%.
As the FDA reviews Pfizer's shot, the agency has also set a date to consider another mRNA-based coronavirus vaccine from Moderna that posted even more impressive first-round data. The FDA's Vaccines and Related Biological Products Advisory Committee will pore over Moderna's late-stage stats on Dec. 17, the agency said in a release, setting the stage for an emergency use authorization to follow.
Looking for a win in the waning days of Donald J. Trump's presidency, White House Chief of Staff Mark Meadows called FDA Commissioner Dr. Stephen Hahn into an early morning meeting Tuesday to quiz him about why Pfizer's vaccine hasn't scored an EUA already, Axios reported. In a statement to the news outlet before that meeting, Hahn said agency scientists would "take the time that's needed" for a review, potentially putting him on a bad footing with the White House. The shot is scheduled for an FDA advisory panel review Dec. 10. Story
The NIH's National Institute of Allergy and Infectious Diseases kicked off the fourth iteration of its catchall COVID-19 trial, investigating leading treatments for moderate-to-severe COVID-19. Patients in one arm of the study will receive a combo of generic steroid dexamethasone and Gilead Sciences' remdesivir, marketed as Veklury in the U.S. Meanwhile, a second arm will receive remdesivir and Eli Lilly's Olumiant (baricitinib).
Amid rising domestic case counts and deaths, Russia is seeking to import a swath of foreign drugs to help fight a surge in COVID-19, Reuters reported. The nation has worked to develop its own treatments for the virus, with names like Coronavir and Avifavir, but has run into chronic shortages in some regions.
A new study from the Centers for Disease Control and Prevention found that the earliest cases of COVID-19 were likely on the West Coast as early as December 2019, potentially weeks before global health regulators became aware of a growing outbreak in Wuhan, China, the Wall Street Journal reported.
More research from the University of Oxford suggests the risk of long-term lung damage in COVID-19 patients—defined as aftereffects that last more than three months—is higher than previously known.
UPDATED: Monday, Nov. 30 at 3:11 p.m. ET
Novavax is facing "additional questions" from the FDA over its decision to tap Fujifilm Diosynth's North Carolina plant for commercial-scale manufacturing of its vaccine for a phase 3 North American trial, pushing the study start date into late December at the earliest. The FDA's line of questioning remains unclear and a Novavax spokeswoman couldn't clarify the regulator's inquiries over email. While Novavax's U.S. trial is delayed, the biotech has finished enrollment for a 15,000-person U.K. phase 3 and is wrapping up a phase 2b study in South Africa, the company said. Story
Pfizer has been running "dry rehearsals" of its shot deployment scheme at more than 50 U.S. distribution sites, Operation Warp Speed's Gen. Gustave Perna said last week. Pfizer has also created YouTube videos for staffers to consult as they receive, store and dispatch the vaccine. “As Pfizer has walked the administration sites through the execution, we see growing confidence in everybody,” Perna said, adding that he'd personally gone through the process, which he described as "very, very doable." Story
Meanwhile, Pfizer's shot could snare approval "within days" of its Dec. 10 advisory panel review, Department of Health and Human Services secretary Alex Azar said Monday. "Moderna is basically one week behind that," he added. After that, it will be up to governors to decide who receives the first slate of shots. The CDC's Advisory Committee on Immunization Practices is continuing talks on how to divvy up vaccines, Azar said, and he expects more information on those priorities this week.
Kantaro Biosciences, a joint venture between Mount Sinai Health System and RenalytixAI, won an emergency nod for its COVID-19 antibody diagnostic, COVID-SeroKlir. The diagnostic provides a semi-quantitative blood test that measures the amounts of IgG antibodies—specifically those that target the virus’s spike protein and its receptor-binding domain, potentially slowing the course of an infection. The diagnostic won a CE mark in Europe in late October and Kantaro aims to crank out up to 10 million tests per month through a commercial partnership with Bio-Techne. Story
Northwestern University researchers say they've developed an AI algorithm to automatically detect signs of COVID-19 on a basic X-ray of the lungs. The AI could be used to rapidly screen patients upon entry into the hospital, especially for reasons unrelated to coronavirus symptoms, triggering protocols to help protect healthcare workers. Story
The FDA delayed a decision on Revance's frown-line injection daxibotulinumtoxinA thanks to COVID-19 restrictions that kept agency inspectors from assessing the company's Newark, California manufacturing facility on time. The delay didn't turn up any immediate manufacturing or data issues, and Revance's drug could still snare approval in the first half of 2021, Mizuho analysts wrote. Story
The European Medicines Agency's safety committee, PRAC, has called for a labeling update on all products containing chloroquine and hydroxychloroquine about the risk of suicidal behavior and psychiatric disorders. Neither drug is approved to treat COVID-19, but both have been used off label in the disease despite underwhelming readouts in large clinical trials.
Scientists and COVID trial participants are combatting vaccine misinformation on TikTok. One user, Dr. Noc, hard at work developing an antibody treatment for COVID-19 when not posting on the video sharing platform, has been uploading science-based videos since February. Meanwhile, Ashley Locke, who posted about her experience in AstraZeneca's vaccine trial, has racked up more than 2 million views on her post. Since then, she's made videos and answered questions from her comments section about side effects, use of masks post-trial and more.
UPDATED: Monday, Nov. 30 at 9:56 a.m. ET
Moderna said it will apply on Monday for an emergency use authorization from the U.S. FDA and for conditional marketing authorization from the EMA, with rolling review underway in other territories. The company slightly adjusted its mRNA-1273’s efficacy stat to 94.1% from the previous 94.5% now that it has accrued 196 infected cases from a phase 3 trial. Still, no severe COVID-19 cases have cropped up in the vaccine arm, while the placebo group had 30. Story
AstraZeneca isn’t so lucky with its University of Oxford-partnered AZD1222. The company now expects to run another phase 3 trial as scientists raised doubts about its existing data. The company previously revealed that the experimental shot was 90% effective in a subgroup of phase 3 trial participants who got a half-dose of the vaccine by mistake, while the correct dosing only demonstrated efficacy of about 60%. “Now that we've found what looks like a better efficacy, we have to validate this, so we need to do an additional study,” CEO Pascal Soriot told Bloomberg. Story
Meanwhile, the AZ shot is facing an adverse reaction allegation in India, where its partner Serum Institute of India is running a trial. A 40-year-old man claims he suffered serious “neurological and psychological” symptoms after receiving the vaccine, according to Reuters. The trial volunteer is seeking 50 million rupees ($676,288) in compensation and suspension of activities around the vaccine. The Indian Council of Medical Research is looking into the matter but has so far recommended that the trial proceed.
Another vaccine that has reported phase 3 data, Pfizer and BioNTech’s BNT162b2, has already started commercial deliveries from its manufacturing site. A first batch of the vaccine reportedly arrived at Chicago’s O’Hare International Airport in a chartered flight from Brussels in what the Federal Aviation Administration described as the first “mass air shipment” of a COVID shot. The Pfizer vaccine is expected to be authorized for emergency use by mid-December. Until then, no vaccine can be shipped to administration sites. Story
With BNT162b2, the U.K. is poised to become the first Western country to approve a COVID-19 vaccine. Domestic health regulators are on track to greenlight the Pfizer-BioNTech shot within days, and deliveries will begin within hours of authorization, the Financial Times reported, citing government officials.
The U.K. has appointed Nadhim Zahawi, a member of the U.K. parliament, as a new minister to oversee the rollout of COVID vaccines in England. Britain has gained access to 357 million doses of vaccines from seven developers, including an additional 2 million doses of Moderna’s mRNA-1273 that it just secured on top of the original 5 million agreed. It has also placed orders for 100 million doses of the AZ-Oxford vaccine and 40 million doses of Pfizer-BioNTech's.
Also in the U.K., efforts remain ongoing in the search for effective COVID therapeutics under the Recovery master trial. Colchicine, a drug used to treat gout and Behçet's disease, has been included in the trial. Investigators expect to enroll at least 2,500 patients to the colchicine arm to evaluate its ability to reduce dangerous immune overreactions in hospitalized patients, including its impact on death rate, hospital stay and need for ventilator support.
In the U.S., antibody therapies by Regeneron and Eli Lilly have already won emergency nods for outpatients, and the Trump administration has secured 300,000 doses from each company. But experts raised concerns that it would be difficult for medical centers to keep their infusion sites separate from those used by patients not infected with Sars-CoV-2.
As research around COVID presses on, accusations of attempts to steal those discoveries have pointed at Russia, China and Iran. Now, North Korean hackers have been fingered in a seemingly failed attempt to infiltrate AstraZeneca and its vaccine work. The hackers posed as recruiters and approached AZ staffers with fake job offers, and then sent malicious emails designed to gain illegal access to company computers, two people with knowledge of the matter told Reuters. Story
COVID has obviously attracted a lot of research resources during the pandemic, causing delays to clinical trials in other areas. The lockdowns also restricted scientists from accessing crucial research facilities and equipment. A survey of scientists at The Institute of Cancer Research in London found that oncology experts on average expect an average six-month delay to their scientific advances.
Indian generics player Hetero penned a deal to produce more than 100 million doses per year of Russia’s COVID vaccine Sputnik V in India starting from 2021, the Russian Direct Investment Fund, Russia’s sovereign wealth fund and backer of the shot, said Friday. The adenovirus-vectored vaccine recently touted a 91.4% efficacy at an interim analysis involving nearly 19,000 volunteers.
UPDATED: Wednesday, Nov. 25 at 9:30 a.m. ET
Pfizer and BioNTech's vaccine candidate could roll out shortly after Dec. 10, Alex Azar said. “We believe we can distribute vaccine to all 64 jurisdictions within 24 hours of FDA authorization," he said, adding that the hope is to kick start vaccinations as soon as shipments arrive. By mid-December, 6.4 million Pfizer doses are expected to go out to states and territories, out of a total 40 million doses slated for delivery this year, General Gustave Perna, who oversees Operation Warp Speed, said. Warp Speed will also run test shipments this week to prepare for its distribution push.
COVAX, the World Health Organization's equitable vaccine distribution scheme, has secured hundreds of millions of AstraZeneca doses, said Gavi, the Vaccine Alliance—co-leader of the initiative. Gavi hailed AZ's recent data reveal as "positive news for the COVAX vision of equitable access." Even more promising, AZ's shot can be shipped and delivered using traditional refrigeration and storage methods, and the company has pledged to supply shots at no profit while the pandemic persists, Seth Berkley, CEO at Gavi, said.
BioNTech and Shanghai Fosun plan to launch a phase 2 trial of the German biotech's vaccine hopeful, BNT162b2, in China, the companies said Wednesday. Testing is slated to take place at Jiangsu Provincial Center for Disease Control and Prevention and will assess safety, plus the shot's ability to provoke an immune response.
Sinopharm filed a request with the National Medical Products Administration to start marketing at least one of its COVID-19 vaccine candidates in China, Xinhua Finance News reports, citing deputy general manager Shi Shengyi. The report did not specify which—or how many—of the drugmaker's two inactivated candidates, both still in late-stage testing, were up for approval. Meanwhile, an anonymous Sinopharm exec told South China Morning Post the Xinhua report was "inaccurate" and the company had yet to file for a marketing nod.
States are on the hook to prioritize who gets the first coronavirus vaccine doses, HHS Secretary Alex Azar said. While a CDC advisory committee plans to meet immediately after an approval to hash out early access, governors will have "final say," which could lead to widely differing distribution schemes across the nation. The CDC's panel, the Advisory Committee on Immunization Practices, on Monday said distribution should aim to tackle health inequities and disproportionate infections, deaths and hospitalizations among Black, Latino and Native American populations.
The European Union wants to accelerate the process for issuing compulsory licenses, which could allow the bloc to bypass intellectual property rights on generic drugs to shore up supply during the pandemic, Reuters reports. The move would serve as a "last resort" and "safety net," an EU document said, essentially giving EU states the ability to manufacture generic meds without drugmakers' consent. Compulsory licensing is allowed by the World Trade Organization as a means to waive normal regulations during an emergency.
Plus, the European Medicines Agency (EMA) thinks it could issue a "positive opinion" on a vaccine before Christmas, Emer Cooke, executive director of the agency, told the Irish news outlet RTE. Cooke on Tuesday said the EMA aims to make an authorization decision around the same time as the U.S. FDA, which plans to review Pfizer's shot in mid-December.
Public health officials and drugmakers should be transparent about unpleasant vaccine side effects to ensure people return for a second dose, doctors said during a meeting with CDC advisors. High fever, body aches, headaches, exhaustion and other symptoms were reported by participants in Moderna and Pfizer's vaccine trials in September. While unpleasant, symptoms usually passed after about a day, participants said. Those side effects are "no walk in the park," but messaging must be clear so that patients aren't deterred from getting a second dose, doctors said.
UPDATED: Tuesday, Nov. 24 at 3:08 p.m. ET
AstraZeneca's late-stage vaccine proved 90% effective in a small group of subjects that received a half-dose primer followed by a full-dose booster—but that was never the plan. "It was a mistake," Mene Pangalos, EVP at the company, told Reuters. The error became apparent when some participants had milder-than-expected side effects, which led researchers to realize they'd "underpredicted the dose of the vaccine by half,” he said. It's unclear how effective the primer-dose regimen truly is. Only 2,741 subjects received the half dose in a more than 30,000-person phase 3. Story
Among more than 74% of Americans who've heard about Pfizer's promising vaccine data, 48% now report a more positive view of the company, The Harris Poll found. Meanwhile, 41% of respondents said they've developed a more favorable view of drugmakers involved in the pandemic vaccine race, while 40% report a sunnier outlook on the industry as a whole. Forty-six percent of people polled also had a more favorable view of the vaccine development process, while 39% adopted a more positive outlook on the approval process. Story
GE Healthcare launched an AI algorithm that can read X-rays to pin down proper placement of ventilator tubes in patients under critical care. As many as one in four patients intubated outside of an emergency room may have a misplaced endotracheal tube, the company estimates, which can lead to severe complications like over-inflating or collapsing of a lung. The algorithm, included in GE's Critical Care Suite, works on the mobile X-ray scanner itself and automatically detects the tube in chest X-ray images, helping flag potential dangers. Story
Two single-domain antibodies, or nanobodies, developed by Twist Bioscience protected coronavirus-infected hamsters from weight loss—a key indicator of disease severity, the biotech said. The weight-loss protection was comparable to results with convalescent plasma in previous clinical studies. Armed with positive hamster data, Twist is now weighing its options, including potentially licensing out the assets for further development, a company spokesperson said. The candidates could be used to develop a preventive daily nasal spray, Twist added. Story
More than 175 U.S. patients with critical COVID-19 respiratory failure and a severe comorbidity have entered into an expanded access protocol (EAP) with NeuroRx and Relief's RLF-100, also known as aviptadil. Of the 90 patients who've so far reached 28 days followup, 72% survived to day 28, the companies said. In a previous comparison between 21 patients given RLF-100 and 24 on standard of care, only 17% of those in the control group survived to day 28, while survival rate with RLF-100 was similar to the 72% figure reported Tuesday, the companies said.
Thirteen African nations are teaming up on a clinical trial to test whether drugs for malaria, HIV, certain cancers and other diseases could prevent moderate COVID-19 cases from becoming more severe, The New York Times reports. The trial will be carried out by ANTICOV, a consortium of 26 African and European clinical institutions. Testing has already kicked off in the Democratic Republic of Congo, with Kenya close behind. Meanwhile, the Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan and Uganda are waiting on regulatory approval to pitch in.
Reckitt Benckiser’s latest campaign for its over-the-counter cold and flu brand Mucinex encourages patients to "be an ally" to doctors by saying thanks and posting an online review. That support is more important than ever during the pandemic, Claudine Patel, general manager of marketing for RB's North America Consumer Health unit, said. The company has partnered with Healthgrades.com to set up a dedicated page slated to roll out digital ads and social efforts from physician influencers. RB's thinking is backed by data, too: A recent Mucinex and Harris Poll found that 80% of Americans who left online doctor reviews did so to report a positive experience. Story
UPDATED: Tuesday, Nov. 24 at 9:30 a.m. ET
The European Union on Wednesday is expected to approve a deal securing up to 160 million doses of Moderna's vaccine candidate, Ursula von der Leyen, head of the European Commission, said. The bloc in August said it had wrapped preliminary talks with Moderna to lock down 80 million initial doses and an option to purchase 80 million more. Moderna last week revealed its shot was 94.5% effective in phase 3. Story
Plus, Moderna tapped Swedish drugmaker Recipharm to carry out fill and seal packaging on its mRNA-based vaccine candidate. Work will take place at Recipharm's manufacturing unit in Monts, in central France.
Thanks to a rolling EU review, AstraZeneca thinks it could see a "relatively fast approval" for its shot candidate in Europe, Iskra Reic, EVP of the company's Canadian and European operations, told Euronews. Should the vaccine pass the European Medicines Agency's bar, Reic said she was "absolutely convinced" AZ could deploy the shot to all EU member states in roughly the same timeframe. She added the company was still parsing the biology behind Monday's puzzling data reveal and cautioned against the unreliability of cross-trial comparisons.
Médecins Sans Frontières (MSF) called on AstraZeneca to re-commit to its no-profit vaccine pledge and urged the drugmaker to open the books on its licensing and purchase deals so that people and governments could demand a fair price. AZ has said it won't profit off its shot during the pandemic, but terms of a deal disclosed by the Financial Times show the drugmaker can declare the pandemic over as early as next July—well before MSF thinks COVID-19 will be under control. That could open the floodgates for steep shot pricing in 2021's second half, MSF warned.
Meanwhile, Italy is set to receive 16 million AstraZeneca doses in early 2021 through the European Union's supply deal, a government source told Reuters. The country will receive an initial 4 million doses in January, followed by another 12 million between February and April, the source said. Plus, Italy is also in line to receive 3.4 million doses of Pfizer and BioNTech's shot as early as January.
Brazil has collected enough infection data from a phase 3 trial of Sinovac's shot hopeful to potentially unveil interim data in early December, Reuters reports, citing trial organizers from the country's Butantan Institute. The study now has 74 confirmed cases, passing the threshold of 61 infections needed for an interim analysis, Dimas Corvas, the institute's director, said. Brazilian health officials have pegged a possible approval of Sinovac's shot for December or January.
The Nanovaccine Institute at Iowa State University is teaming up with drug delivery device specialist Zeteo Biomedical to develope a next-generation nasal spray vaccine for COVID-19. The single-dose prophylactic, designed for stability at room temperature, could potentially be self-administered using Zeteo's intranasal delivery device. Meanwhile, the university in late October scored $2 million from the Coronavirus Aid, Relief and Economic Security Act to support its development efforts. Story
Russia's Sputnik V vaccine proved 91.4% effective in a second interim analysis from the country's 40,000-person phase 3. The second analysis was carried out after 39 cases were confirmed in the trial—31 in the placebo arm and 8 in the group who received the vaccine. No unexpected health scares were observed, with typical side effects including injection site soreness, fever, fatigue, weakness and headache. Russia plans to unveil further data once 78 infections have been confirmed. Story
And Russia plans to sell Sputnik V for less than $10 per dose internationally and make it free for its own citizens, the Russian Direct Investment Fund said. The country's current deals with foreign drugmakers provide capacity for enough doses for 500 million people per year, starting in 2021, though Russia says it's on the hunt for additional deals to boost supply. Meanwhile, Russia expects to send the first doses out to customers in January.
UPDATED: Monday, Nov. 23 at 3:35 p.m. ET
Moderna will submit its shot for emergency authorization by month's end, with a review slated to take place on Dec. 17, Operation Warp Speed chief Moncef Slaoui told ABC News. Meanwhile, an FDA advisory committee is set to review Pfizer's vaccine data Dec. 10, he said, and some doses could start rolling out the very next day if the shot snares a swift authorization. It remains unclear how long the review process will take. Story
Merck struck a $425 million cash deal to buy OncoImmune and its coronavirus treatment CD24Fc, aimed at the sickest COVID-19 patients. Interim data from a phase 3 trial showed improvements against the virus after a separate study showed gains in stem cell transplant patients earlier this year. Currently Merck has two COVID-19 vaccines in the clinic and an antiviral in phase 2/3 development. Story
AstraZeneca's COVID-19 vaccine candidate can be stored and transported at normal refrigerator temperatures for at least six months, allowing it to be easily administered in a wider variety of healthcare settings—including in low- and middle-income countries. These properties could give the viral-vector shot a logistical leg up over its mRNA-based rivals, which require ultra-cold storage. Story
Following its FDA authorization over the weekend, the federal government will begin distributing Regeneron’s antibody therapy on Tuesday, starting with more than 30,000 courses of treatment, according to a report from Reuters.
The NIH awarded nearly $45 million to expand its efforts aimed at providing access to COVID-19 diagnostics among underserved populations. The federal program added 20 institutions across seven states and territories to its research network, bringing its total funding amount to over $283 million and 55 participating organizations.
A mathematical model by the University of Colorado at Boulder showed that screening half the U.S. population regularly with cheap, rapid COVID-19 tests could help completely eliminate the virus within weeks. Combined with personal quarantines, restaurants and schools would be able to stay open, the researchers said.
UPDATED: Monday, Nov. 23 at 9:15 a.m. ET
On average, two separate regimens of AstraZeneca's vaccine candidate proved 70% effective in late-stage trials, the drugmaker said. Most subjects—8,895, to be exact—received two full doses of the shot, which boasted 62% efficacy in that group. Meanwhile, a smaller cohort of 2,741 subjects got a half-dose for their first shot, followed by a booster; efficacy was 90% in that arm. Nobody who received the shot was hospitalized or had a severe case of COVID-19 and no serious side effects linked to the vaccine have been confirmed, AZ said. Story
AstraZeneca should have enough of its candidate vaccine to produce 200 million doses by year-end, with enough drug substance to crank out 700 million doses globally by the end of 2021's first quarter, operations exec Pam Cheng said Monday. The drugmaker will keep the "active" drug substance in stock as it awaits approval worldwide, she added. The company aims to provide the U.K. with about 4 million finished doses this year, followed by an estimated 40 million doses in Q1, though AZ could double that supply if it proceeds with an initial half-dose, Cheng said.
Regeneron's antibody cocktail bagged an emergency nod from the FDA Saturday to treat mild- to-moderate, non-hospitalized patients at high risk for progressing to severe COVID-19. The therapy—a combination of the monoclonal antibodies casirivimab and imdevimab—was shown to reduce viral load significantly better than placebo in a phase 1/2 trial and, more importantly, lowered the risk of hospitalization within 28 days. Regeneron aims to make the treatment available for around 80,000 patients this month and 300,000 patients by the end of January. Story
Pfizer and BioNTech's vaccine hopeful could win U.K. authorization in as little as a week—ahead of U.S. clearance, government sources told The Telegraph. British regulators are about to start their assessment of the shot, and the country's National Health Service has been told to prepare to start administering the vaccine by Dec. 1. Pfizer has pledged to provide 10 million doses to the U.K. this year out of a total 40 million-dose order.
India's Bharat Biotech expects its vaccine hopeful, Covaxin, to boast at least 60% efficacy, Sai Prasad, president of quality operations at the company, said. Bharat kicked off phase 3 trials on Nov. 20 and plans to launch its shot in 2021's second quarter. Covaxin is being developed in collaboration with the Indian Council of Medical Research's National Institute of Virology.
UPDATED: Friday, Nov. 20 at 3:05 p.m. ET
Novartis pitched in $50 million upfront to snare a global license to develop and market Mesoblast's cell therapy remestemcel-L in COVID-19. The FDA last month rejected Mesoblast's filing for the treatment in children with steroid-resistant graft-versus-host disease, though the company in May had already kicked off a phase 3 trial to see whether its cell therapy could help COVID patients with acute respiratory distress syndrome. Novartis, which already boasts an approved cell therapy, will also help scale up commercial manufacturing to meet pandemic demand. Story
Cue Health's rapid, point-of-care coronavirus diagnostic test will be shipped out to Alaska, Florida, Louisiana, New Jersey and Texas in a government pilot program under the Department of Health and Human Services. The molecular test, which uses nasal swabs and a cartridge-based reader that sends results to a connected smartphone, won FDA authorization in June, and should tee up diagnoses in healthcare settings with larger groups of people at high risk for COVID-19, like nursing homes and long-term care centers. Story
A pre-engineered version of Adagio's experimental antibody, ADG20, protected against SARS-CoV and SARS-CoV-2—the virus that causes COVID-19—in mice, the company reported on the preprint site bioRxiv. In lab tests, the drug was also able to neutralize two related coronaviruses circulating in bats—potentially giving it an edge over other antibodies in the works, which tend to trade breadth of activity in multiple viruses for potency against SARS-CoV-2 specifically, said Laura Walker, Ph.D., chief scientists at Adagio. Story
Serum Institute of India, which has already produced millions of doses of AstraZeneca's vaccine candidate, will seek emergency approval in-country as soon as regulators in the U.K. clear the shot for use among the general public, CEO Adar Poonawaala said. The company is almost on "autopilot" as it awaits vaccine results; SII can then start cranking out "hundreds of millions" more doses, Poonawalla said.
The United States, the European Union and several other wealthy nations on Friday pushed back on a proposal to waive certain intellectual property rights for COVID-19 drugs and vaccines, Reuters reports, citing three trade sources. That lack of support means the proposal will likely fail when it goes before the World Trade Organization next month. The waiver has been backed by a slate of developing countries, China, the World Health Organization and Médecins Sans Frontières.
Hungary's plans to test and potentially produce Russia's controversial Sputnik V vaccine could strain its relationship with the European Union and undermine public confidence in a vaccine, the European Commission said. The vaccine must be authorized by the European Medicines Agency before it can go out to EU states, though the regulator says it has yet to receive any data from Russia. Meanwhile, Hungary on Thursday imported its first doses of Sputnik V, which it will study to "make a well-founded decision on potential usability and approval," the country's foreign minister said.
UPDATED: Friday, Nov. 20 at 9:29 a.m. ET
Eli Lilly and Incyte's rheumatoid arthritis med Olumiant, in tandem with Gilead's Veklury (remdesivir), won an emergency nod from the FDA to treat hospitalized COVID patients requiring oxygen support, mechanical ventilation or extracorporeal membrane oxygenation. An NIAID trial of the drug showed patients on the combo had a median recovery time of seven days, compared to the placebo and Veklury arm's eight days. Patients on the combo were also less likely to die or need mechanical ventilation after 29 days and had better odds of improvement at day 15 versus the control group. Story
Meanwhile, a World Health Organization panel on Thursday advised against the use of Gilead's Veklury to treat COVID-19. The panel's guidance, published in the journal BMJ, "concluded that the evidence did not prove that remdesivir has no benefit; rather, there is no evidence based on currently available data that it does improve patient-important outcomes." Gilead, for its part, told The Wall Street Journal it was "disappointed" that the WHO's Veklury guidelines came at a time when cases are mounting worldwide. Story
The European Union has agreed to pay €15.50 ($18.34) per dose for Pfizer and BioNTech's vaccine candidate, Reuters reports, citing an EU official close to the matter. That would put the EU on the hook to pay up to €3.1 billion ($3.7 billion) for its 200 million-dose order, rising to €4.65 billion ($5.51 billion) if the bloc chooses to purchase another 100 million doses. Separately, the EU confirmed it would pay €10 ($11.84) per dose for CureVac's mRNA-based vaccine, for an initial supply of 225 million doses. The block this week secured up to 405 million doses of CureVac's shot hopeful.
Roche is poised to start delivering Regeneron's two-antibody cocktail in 2021's first quarter, CEO Severin Schwan told Bloomberg. An emergency nod for Regeneron's antibody cocktail could be granted "very soon," though initial demand is sure to outstrip supply, Schwan said. The companies will have a combined capacity of roughly 2 million doses next year. Meanwhile, Roche is working to ramp up production as fast as possible, Schwan added.
Sinovac could have phase 3 data on its vaccine hopeful, CoronaVac, by next month, Weining Meng, senior director of the Chinese biotech, said Friday. The shot is in late-stage testing in Brazil, Indonesia and Turkey. Sinovac earlier this week published early- to mid-stage data showing CoronaVac sparked a swift immune response but lower antibody levels than those seen in patients who've recovered from COVID-19.
ApiJect Systems on Thursday was approved by the U.S. government for a $590 million loan to produce single-dose injectors for COVID-19 vaccine candidates. ApiJect's self-contained device has yet to pass the FDA's bar, prompting health experts to question the government's loan. The company, meanwhile, plans to build a facility with capacity for 3 billion pre-filled injectors annually. The facility would be able to support candidates that require standard cold storage or ultra-cold storage up to -94 degrees Fahrenheit—the temperature required for Pfizer's vaccine. Story
UPDATED: Thursday, Nov. 19 at 3:20 p.m. ET
Pfizer and its German partner BioNTech plan to file for an emergency use authorization for their shot in the U.S. Friday, BioNTech CEO Uğur Şahin told CNN. Depending on the speed of the review process, the partners' vaccine could snare authorization or conditional approval in 2020, with distribution efforts kicking off before year-end, Şahin said. Pfizer on Wednesday announced its vaccine had shown 95% efficacy in phase 3.
Meanwhile, BioNTech is working on a new formulation for its shot that could enable shipping at room temperature, Şahin said during his CNN interview. The development process is happening "in parallel" with Pfizer and BioNTech's current efforts and could bear fruit as early as the second half of 2021, he said. Concerns have mounted over storage and shipping requirements for the partners' candidate, which must be kept at -94 degrees Fahrenheit—far colder than than the requirement for most vaccines.
And Pfizer aims to start distributing its vaccine "within hours" of scoring an emergency nod, starting with shipments wherever the shot is cleared first, CEO Albert Bourla told Sky News. This could spark a "race to regulate" as authorities hustle to review data and lock down doses for their countries, he added. If one regulator OKs the shot before another, the "ethical" move would be to start sending doses to people in that jurisdiction, though patience is crucial, since demand will outpace supply early in the vaccination process, Bourla said. Story
AstraZeneca's vaccine could launch with little lag behind Pfizer and Moderna's candidates, currently at the head of the pack, Andrew Pollard, head of the University of Oxford's vaccine trial, said. Still, he emphasized that AZ and Oxford aren't rushing, nor are they competing with other developers. Phase 3 data is expected before Christmas, at which point it will be sent off to regulators. If that process moves at a pandemic-appropriate pace, "it's possible that things could line up so there is not very much difference in timing between the various different vaccines,” Pollard said.
Siemens Healthineers developed a quantitative test that measures the antibodies able to neutralize coronavirus. The IgG antibody test—a new version of the serology test Siemens launched over the summer, which estimates the numbers of coronavirus antibodies in a person’s bloodstream—boasts a CE mark in Europe and is under review for emergency use at the FDA. The test should help gauge the level of immunity conferred by a vaccine, and the company plans to make it available internationally via its Atellica, Advia Centaur and Dimension laboratory hardware. Story
The Department of Health and Human Services (HHS) put the kibosh on a $15 million contract that would have helped secure celebrities to feature in the agency's controversial $250 million ad campaign to "defeat despair and inspire hope" amid the pandemic. While Hollywood will no longer make an appearance, HHS is pressing on with a new, "science-based" approach to its campaign. Story
Médecins Sans Frontières (MSF), also known as Doctors Without Borders, has called for governments to support a request to waive certain intellectual property rights on COVID-19 drugs and vaccines during the pandemic, slated for consideration at an upcoming World Trade Organization meeting. Kenya, Eswatini, India and South Africa are co-sponsoring the waiver, which so far has the support of 99 countries. “All COVID-19 health tools and technologies should be true global public goods," Sidney Wong, executive co-director of MSF's Access Campaign, said.
UPDATED: Thursday, Nov. 19 at 9:30 a.m. ET
In late October, AstraZeneca teased phase 2 data showing its vaccine spurred an immune response in patients both young and old. Now, those results have been peer reviewed and published in The Lancet. Healthy adults over the age of 56 showed a similar immune response to that of younger patients, and the oldest participants, whose median age was between 73 and 74, experienced milder side effects than the younger cohort. AZ's phase 2 enrolled 560 adults, 240 of whom were over the age of 70. Story
If Pfizer's shot wins an emergency nod, vulnerable groups—most likely healthcare workers, first responders and elderly Americans living in nursing homes—could start receiving the vaccine in December, HHS secretary Alex Azar said Tuesday. By January, there should be enough Pfizer doses for everyone in that initial group and by March or early April, Azar expects to have enough vaccines from Pfizer and other developers for all Americans.
Roche's arthritis med Actemra, also known as tocilizumab, hit a "key efficacy endpoint" among seriously ill COVID-19 patients. It's unclear if the drug helped people stay alive or shortened the time on intensive care support like mechanical ventilation, though more details should be published in a matter of weeks, Anthony Gordon, lead investigator of the 303-patient trial, said.
Later today, the U.S. International Development Finance Corp (DFC) will likely reveal that it's extended its $590 million loan to ApiJect—maker of an unproven injection device still awaiting FDA clearance, NPR reports. The single-use device is meant to offer an alternative to vials and syringes, supplies that could become strained as shots start to roll out. Having a backup plan for glass vials is important, but the fact that the government has invested so much in a technology that has yet to go through the FDA is cause for concern, one health expert told the news outlet.
Close to 1 million people have received Sinopharm's experimental COVID-19 vaccine, the Chinese drugmaker said Wednesday. Since July, the country has allowed essential workers and other limited groups to take three separate vaccine candidates—two from Sinopharm and one from Sinovac—none of which have completed phase 3 testing. No serious side effects have been reported by those receiving the experimental shot in emergency use, Liu Jingzhen, chairman of Sinopharm, said, though it's unclear which vaccine he was referring to.
The concept of "herd immunity" comes with some big caveats, health experts told Reuters. It would not imply individual protection from the virus, since the thrust of the idea is to protect the vulnerable. Meanwhile, we still don't know how fast the virus spreads under normal circumstances, without travel and social restrictions in place, Winfried Pickl, professor of immunology at the Medical University of Vienna, said. Finally, while the first vaccines poised to hit the market will likely prevent individual COVID-19 cases, they may not stop the spread of the virus to unvaccinated individuals.
UPDATED: Wednesday, Nov. 18 at 2:50 p.m. ET
The FDA approved Lucira Health's all-in-one COVID-19 diagnostic, which people over the age of 14 can use at home with a prescription. The kit—which relies on a swab and aims to deliver results in about 30 minutes—shrinks a molecular test for the virus' genetic code down to a handheld unit, complete with all the necessary chemical reagents. The company expects the test to become available nationwide early next spring with a price tag of $50. Story
AstraZeneca and the University of Oxford have enlisted research services firm CCT Research to help recruit 1,500 patients for a vaccine trial in Arizona. CCT works as a clinical site network, embedding research studies within local communities. The Arizona trial, slated to run at Bayless Integrated Healthcare's site in downtown Phoenix, will compare AZ's shot hopeful against placebo in healthy patients over the age of 18. Story
Johnson & Johnson over the next five years will invest $100 million to help address racial inequities in healthcare, drawn into sharp focus against the backdrop of COVID-19. J&J's efforts are threefold: work with local communities; expand and add partnerships; and increase internal efforts to hire and promote people of color to the management level and above. In one snapshot of the drugmaker's community outreach efforts, J&J plans to grow its support of mobile health clinics—already delivering COVID-19 testing and information on clinical trial inclusivity—for communities of color. Story
With cases mounting in the U.S., drug and vaccine trials are receiving an unexpected tailwind, The New York Times reports. Moderna, which announced positive early results on its shot hopeful Monday, had originally aimed to submit data to experts after observing 53 COVID-19 cases in its phase 3 trial, but higher infection rates allowed the biotech to base its readout on 96 sick subjects. Enrollment in Regeneron's antibody cocktail trial has also hastened this month, a company spokeswoman told the news outlet.
In late October, 58% of Americans said they would get a COVID-19 vaccine—up eight points from a low of 50% in September, a new Gallup poll found. Meanwhile, 42% of the 2,985 American adults surveyed said they definitely wouldn't get a vaccine, down slightly from 50% in September. Thirty-seven percent from that group cited rushed vaccine development as the main cause for concern, while another 26% said they wanted to wait for confirmation that an approved shot is safe.
Hummingbird Bioscience could roll out its experimental antibody in Singapore and other countries by early 2021, Jerome Boyd-Kirkup, co-founder of the company, told CNBC. Small-scale trials of the treatment, dubbed Hummingbird 115, kicked off in Singapore last month, with phase 3 studies expected to start in December. “We’re aiming for early 2021 for widespread accessibility of this therapy to patients,” Boyd-Kirkup said.
UPDATED: Wednesday, Nov. 18 at 9:25 a.m. ET
Pfizer has obtained the necessary follow-up safety data to pursue an emergency nod for its shot, CEO Albert Bourla , Ph.D., said. The company on Wednesday published detailed data from its phase 3, which showed its mRNA-based vaccine was 95% effective. In the control group, 162 patients developed COVID-19, compared to eight subjects in the vaccine arm. Nine severe cases were observed in the placebo group, versus the vaccine cohort's one. Story
Roche successfully tested its ability to churn out large quantities of Regeneron's experimental antibody cocktail and is ready to kick off manufacturing should the treatment snare approval, George Yancopoulos, Regeneron's chief scientific officer, told Reuters. The Swiss drugmaker could start producing the treatment in 2021's first quarter, a Roche spokesperson added. Regeneron is on deck to provide 300,000 doses of its treatment to the U.S. as early as January, with 50,000 doses already stockpiled.
Sinovac's experimental vaccine can induce an antibody response within four weeks of immunization by giving two doses of the shot at a 14-day interval, the Chinese biotech said in a publication of its phase 1/2 trial in the journal Lancet Infectious Diseases. Sinovac's early- and mid-stage tests took place in April and May. The biotech is now plowing ahead with late-stage trials, although one phase 3 study was stopped in Brazil this month after reports of a serious safety scare. Story
Meanwhile, Brazil's Sao Paulo state will start importing an initial 46 million doses of Sinovac's shot this week, which could be made available in January if the vaccine passes muster with local regulators, the director of the state’s Butantan Institute biomedical center said. Butantan, which is organizing phase 3 trials of the shot in-country, said last week's pause was unrelated to the vaccine. Meanwhile, Brazil said it would also look to purchase Pfizer's vaccine if the shot is proven effective and registered with the country's health authority, Anvisa.
With lives at stake, the Trump Administration needs to share critical COVID-19 data with President-elect Joe Biden's team, including information on the supply of therapeutics, testing materials, personal protective equipment, ventilators, hospital bed capacity and workforce availability, the American Medical Association, the American Nurses Association and the American Hospitals Association said. Leaders from the trio of healthcare juggernauts signed a letter making their position known a day after Biden warned that more people would die if Trump failed to concede.
It will likely take weeks to determine whether a potential vaccine is worthy of an emergency nod, Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, told Business Insider. Marks added that the FDA will make the process "very open" and said he hopes the extra review time will help boost faith in a final product. "Everything that we are trying to do here, this is all about ensuring the public re-develops the kind of trust they once had in vaccines." Story
Celltrion will likely pursue an emergency nod for its monoclonal antibody, CT-P59, in South Korea before year-end, group chairman Seo Jung-jin said. The company is currently "wrapping up" a phase 2 trial of the drug, he added. Earlier this year, the company announced that its antibody could shorten patients' recovery time with no reported side effects, adding that the drug could neutralize the virus within four to five days, potentially protecting patients with mild symptoms from developing severe disease.
A scant 15% of airlines feel prepared to transport Pfizer's vaccine hopeful at the required, ultra-cold temperature of -94 degrees Fahrenheit, a recent survey by an air cargo association and drug shipper's group found. Around 60% said they'd be able to transport Moderna's shot candidate, which must be kept at -4 F. Meanwhile, as airlines scramble to lock down specialized shipping containers, cold storage specialists like Cryoport and Germany's va-Q-tec have seen shares soar, Reuters reports. Story
UPDATED: Tuesday, Nov. 17 at 3:16 p.m.
The U.K. hastily secured 5 million doses of Moderna's vaccine candidate Monday, hours after the biotech unveiled positive phase 3 data on its mRNA-based shot, health secretary Matt Hancock said. The U.K. chose not to purchase Moderna's vaccine earlier this year over concerns about vaccine nationalism and Moderna's then-lack of a dependable European supply chain, The Guardian reported, citing sources close to the matter. Moderna has since signed on manufacturing partners in Switzerland and Spain.
The FDA postponed its decision on Bristol Myers Squibb's CAR-T hopeful liso-cel—picked up in its $74 billion Celgene buyout—thanks to COVID-19 restrictions that kept the regulator from inspecting a Lonza facility in Texas, slated to help churn out viral vectors for the cell therapy. The FDA did not provide a new anticipated action date, BMS said, dimming hopes of a liso-cel approval before year-end. Story
Infectious disease experts now expect a COVID-19 vaccine by May 2021—a month sooner than previously predicted—but that slightly sped-up timeline is joined by growing reluctance to give an authorized shot to patients, a new survey by InCrowd showed. Just 47% of U.S. infectious disease experts said they would feel "highly confident" in prescribing an FDA approved vaccine, InCrowd's October survey found. Respondents further predicted that 40% of patients would also be wary of getting the vaccine.
Ohio Republican Sen. Rob Portman will roll up his sleeve to take part in Johnson & Johnson's phase 3 vaccine trial. He hopes the move will encourage others to enroll in ongoing U.S. shot studies and reassure the public about the safety and efficacy of vaccines once they've moved through clinical trials and the FDA.
New Jersey-based CDMO Cambrex is plugging $50 million into four additional active pharmaceutical ingredient (API) facilities at its Charles City, Iowa, small-molecule drug site. The investment is set to boost capacity by 30% and meshes with the CDMO's goal to offer stateside API production to drugmakers looking for a "reliable" supply chain. U.S. lawmakers have called for more investment in domestic drug production this year as the pandemic puts pressure on an increasingly global pharmaceutical supply chain. Story
China's plan to vaccinate the public with unproven shots may be working too well, The New York Times reports. Five-hundred doses sent to the city of Yiwu were snapped up in a matter of hours. Other cities are limiting doses and asking people to prove they are traveling to qualify. Meanwhile, scalpers are charging as much as $1,500 for vaccine appointments, the news outlet wrote. And while China says it's monitoring vaccinated patients, a consent form for one candidate reviewed by the Times made no mention of the fact that the product was still in testing.
UPDATED: Tuesday, Nov. 17 at 9:13 a.m.
Pfizer kicked off a pilot delivery program for its vaccine in Rhode Island, Texas, New Mexico and Tennessee, selecting the states for their differences in size, diversity, vaccine infrastructure and patient populations split between rural and urban areas, Reuters reports. Pfizer's BioNTech-partnered shot must be stored and shipped at -94 degrees Fahrenheit, fueling recent concerns about widespread storage and distribution.
Germany's CureVac is ramping up manufacturing to produce "pandemic scale" volumes of its vaccine candidate, CVnCoV, the drugmaker said in a release. The company plans to build an integrated European manufacturing network, leveraging CDMOs for each step of the production process. CureVac aims to boost vaccine capacity to upward of 300 million doses in 2021 and up to 600 million doses by 2022. It's also working on an additional, large-scale production facility at its headquarters in Tübingen, Germany. Story
Samsung Biologics is mass producing Eli Lilly's recently authorized monoclonal antibody, bamlanivimab, the South Korean drugmaker said Tuesday. Samsung in May entered a production deal with Lilly and said it has a long-term contract with the antibody developer, but didn't share further details. Lilly is gunning to produce 1 million doses of its antibody by year-end and expects supply to increase in 2021 as more manufacturing resources go live. Story
Meanwhile, U.S. hospitals are already facing high demand and tight supplies of Lilly's antibody, Reuters reports. At $1,250 per dose, the U.S. has so far bought 300,000 doses of bamlanivimab—enough for about a week's worth of new infections at the current rate, health experts said. Doctors also called for "more conservative criteria" on who should be eligible for the treatment; under the current label, the drug is OK'd to treat older patients recently diagnosed with mild to moderate disease, as well as those with risk factors like obesity and diabetes.
India's Bharat Biotech launched a 26,000-person phase 3 trial of its vaccine candidate, Covaxin, developed with the Indian Council of Medical Research. Volunteers will receive two injections of either vaccine or placebo 28 days apart, and Bharat plans to monitor patients over the next year to screen for incidences of COVID-19. The trial is both India's "first phase 3 efficacy study for a COVID-19 vaccine" and the largest late-stage efficacy trial ever conducted in the country, Bharat said in a statement.
The Indian government is in talks with Moderna after the Massachusetts-based biotech unveiled strong data on its mRNA-based vaccine hopeful Monday, the Hindustan Times reports. The country is also holding discussions with domestic vaccine makers like Serum Institute of India, Bharat and Zydus Cadila, along with Pfizer, for potential shot doses, the news outlet reported, citing a senior government official.
UPDATED: Monday, Nov. 16 at 3:07 p.m.
After several months of discussion, the European Union has agreed to purchase up to 405 million shot doses from German vaccine maker CureVac, European Commission President Ursula von der Leyen said. The commission will authorize the deal on Tuesday and expects a signature to come sometime this week, she added. If the shot passes muster in the clinic, the EU would receive 225 million initial doses, with the option to later purchase another 180 million. CureVac in September snared $299 million in German funding for its vaccine work. Story
Former FDA commissioner and Pfizer board member Scott Gottlieb suggested the entry of two "highly effective" vaccines into the market—namely Pfizer's and Moderna's—"could effectively end this pandemic in 2021," CNBC reports. Gottlieb's prediction hinges on the efficacy of those mRNA-based shots once full data are released, combined with the fact that many people will have already had COVID-19 by 2021.
But even with mRNA vaccines from Pfizer and Moderna posting strong data in rapid succession, it's essential that people not become complacent about the virus, the World Health Organization warned Monday. The agency is concerned about mounting case numbers—particularly in Europe and the U.S.—as health workers and healthcare systems in those regions are "pushed to the breaking point," WHO Director-General Tedros Adhanom Ghebreyesus said via Twitter.
States, cities and hospitals across the U.S. are vying for ultra-cold freezers as Pfizer's vaccine rollout looms, Reuters reports. The CDC in August told healthcare providers not to invest in specialty freezers for the shot—which must be stored at -94 degrees Fahrenheit—as it works on its own solution. Meanwhile, states like California, Rhode Island and New Mexico told the CDC they anticipate challenges due to limited freezer supplies, while around half a dozen states said they're looking to secure their own units.
New York, California, Connecticut, West Virginia and the District of Columbia have established committees to vet a potential COVID-19 vaccine once it passes the FDA's bar, while Washington, Oregon and Nevada are each adding a representative to California's panel. The effort, primarily in Democratic-led states, follows mounting vaccine skepticism and concerns that the Trump Administration has prioritized speed above all else in the race for a vaccine. Some health experts, like HHS' deputy chief of staff for policy, Paul Mango, fear those states' reviews could undermine the FDA.
Meanwhile, social media has become a battleground for vaccine misinformation, fueling skepticism that could prevent the U.S. from controlling the virus' spread once a shot is approved, Richard A. Stein, M.D., Ph.D., an adjunct professor at the NYU Tandon School of Engineering and senior editor with the International Journal of Clinical Practice, told Yahoo Finance. Facebook, for its part, has started placing links to the CDC's website on the pages of certain groups circulating false information, while YouTube has started demonetizing anti-vaccine content.
UPDATED: Monday, Nov. 16 at 9:30 a.m. ET
Moderna's mRNA-based vaccine candidate boasted nearly 95% efficacy in the first interim analysis of the drugmaker's phase 3 data. The review covered 95 confirmed cases from the study—90 from the placebo arm and five cases from the group that received the shot, dubbed mRNA-1273. The company submitted data on 11 severe cases of COVID-19, all recorded in the control group. No significant side effects were observed, and Moderna said it would use the data to file for an emergency nod "in the coming weeks." Story
Moderna's shot should remain stable at 36 degrees Fahrenheit to 46 degrees Fahrenheit—about as cold as your standard fridge—for 30 days, new stability testing unveiled by the company shows. Moderna had earlier estimated its vaccine could remain at those temperatures for around a week. Meanwhile, the shot could be kept for up to six months when stored at -4 F, or standard freezer temp. Once removed for administration, the shot can remain at room temperature for up to 12 hours, Moderna said. Story
The European Commission hailed Moderna's "encouraging" vaccine results. The bloc is inking a supply deal with Pfizer and BioNTech later this week, with "more to come soon," EU health commissioner Stella Kyriakides said.
Johnson & Johnson on Monday kicked off a phase 3 trial assessing a two-dose regimen of its vaccine hopeful. The company aims to enroll up to 30,000 subjects; 6,000 are expected to be recruited in the U.K., along with subjects from countries with high case counts, including Germany, Belgium, Spain, the Philippines and the U.S. Participants will receive a second dose of vaccine or placebo 57 days after their first doses, J&J said, with the aim to test whether an additional shot will help protect against the disease for longer. Story
Strong data on Pfizer's shot candidate could convince more people to get vaccinated, NIAID director Anthony Fauci, M.D., told Bloomberg. “What I would hope is that even though there’s a degree of skepticism about vaccines in general, that when the general public sees how effective this vaccine is, we might see a turnaround of the attitude toward vaccination,” he said. Last week, Pfizer announced its shot had so far shown more than 90% efficacy in phase 3.
President-elect Joe Biden's coronavirus team plans to meet with major vaccine makers this week, including Pfizer, Biden's newly elected chief of staff, Ron Klain, said. President Donald Trump's failure to concede the election has hindered the transition of power, keeping Biden's top health officials from working with the government, Klain said. Manufacturing and distribution will pose a significant early challenge to Biden's team. To that end, it's crucial the transition team meet with the HHS "as quickly as possible," Klain added.
Come spring, Russia aims to mainly produce a freeze-dried version of its vaccine, Sputnik V, in a bid to eliminate ultra-cold shipping requirements, Reuters reports. Currently, Russia's shot must be kept at -18 degrees Celsius, or -0.4 degrees Fahrenheit, but the country is working on a lyophilized, powdered version that should remain stable at 35.6 F to 46.4 F. Russia plans to mainly produce that version starting in February, the head of the country's sovereign wealth fund said.
UPDATED: Friday, Nov. 13 at 3:32 p.m. ET
Operation Warp Speed is seeking White House approval to connect with President-elect Joe Biden's transition team, Moncef Slaoui told the Financial Times. Slaoui, a GlaxoSmithKline vet who heads up the government program, said he wants to make sure the effort remains on track, no matter the administration in charge, and he needs a green light from President Donald Trump's team to reach out to Biden's. Trump so far has refused to concede the election, complicating the transition of power.
Qiagen kicked off marketing and distribution of its QIAreach antigen test in the U.S., where the portable diagnostic is under FDA review for emergency lab use. The company hopes to amend the authorization before year-end to enable use in hospitals and other point-of-care settings, and it's pursuing an in vitro diagnostic CE mark in Europe. QIAreach uses a digital hub and interchangeable test-stick cartridges to process more than 30 samples per hour. Story
The European Society of Intensive Care Medicine says Gilead's remdesivir, now known as Veklury, should not be used in COVID-19 patients requiring critical care, the group's president, Jozef Kesecioglu, told Reuters. The European medical association and the U.S. Society of Critical Care Medicine will state the recommendation in an upcoming paper on COVID-19 meds, Kesecioglu added. The advice follows a large WHO study that found the antiviral did little to help hospitalized patients. Gilead, for its part, has contested those results. Story
Patients taking the popular over-the-counter sleep aid melatonin were 28% less likely to test positive for COVID-19, a new study from the Cleveland Clinic found—though more testing is needed before the supplement could be widely used in treatment, the study's senior author said. Researchers used an AI tool to screen data from 26,779 people in the clinic's COVID-19 registry, of whom 8,274 tested positive. Story
The antidepressant fluvoxamine, if taken within the first week of COVID-19 symptoms, could reduce the risk of breathing problems and hospitalization in patients with mild disease, a study from the Washington University School of Medicine in St. Louis found. The COVID-19 Early Treatment Fund will provide additional funding to the university for an 880-person trial to confirm the results.
Among those benefiting from Pfizer's strong vaccine results this week? German brothers Andreas and Thomas Struengmann—founders of the generic drugmaker Hexal, bought by Novartis in 2005. The pair have collectively grown about $8 billion richer this year thanks to their stake in Pfizer's German mRNA partner, BioNTech, BNN Bloomberg reports. Back in 2008, the brothers helped to give BioNTech €150 million in startup funds. They now own around half of the company.
In recent months, state hackers from Russia and North Korea have targeted "seven prominent companies directly involved in researching vaccines and treatments for COVID-19" in Canada, France, India, South Korea and the U.S., said Tom Burt, Microsoft VP of customer security and trust.
Tesla's Elon Musk may have COVID-19, but he wouldn't know it from the tests he's taken. Musk was tested four times Thursday, all with the same BD rapid antigen test, receiving two positive and two negative results, he alleged on Twitter. "Something extremely bogus is going on," he said. Musk's view on the pandemic has been divisive—he later tweeted that the daily testing rate has gone "ballistic" in the U.S. and implied mounting case numbers were due to false positives.
The U.S. recorded more than 160,000 new cases Thursday, a little more than a week after logging 100,000 new infections in a single day for the first time, The New York Times reports. Meanwhile, COVID-19 hospitalizations reached 67,096 Thursday, setting a record for the third straight day, the news outlet said.
The U.S. has an undeniable "independent spirit," but it's time for the public to start following the rules when it comes to preventing the coronavirus' spread, NIAID director Anthony Fauci said. Speaking with other health experts at Washington National Cathedral Thursday, Fauci acknowledged that it's difficult to compare the U.S.' coronavirus response to other nations, given the country's size, but argued that stricter adherence to public safety guidelines would likely prevent another lockdown.
UPDATED: Friday, Nov. 13 at 9:56 a.m. ET
A vaccine ought to be required once one is proven safe and effective, Roche Chairman Christoph Franz told the Swiss newspaper Handelszeitung. He acknowledged that such a move would be controversial, but argued that a mandate would create "freedom in other areas" by halting the virus' spread and potentially ending lockdowns. Franz's statement is his own "personal opinion," Roche told Reuters. The Swiss drugmaker isn't developing a COVID shot but has teamed up with Regeneron to help produce its antibody cocktail.
The pressure is on for China to share data on its COVID-19 vaccine candidates. Brazil suspended a late-stage trial of Sinovac's shot on Monday after a serious patient health scare—right around the time Pfizer revealed its BioNTech-partnered vaccine had so far shown more than 90% efficacy in phase 3. Now, lack of transparency threatens to put China's vaccine diplomacy in jeopardy, health and political experts warn.
Shanghai-based Fosun, which has exclusive rights to Pfizer and BioNTech's shot in the Greater China region, has ID'd a storage site near the Hong Kong airport that could allow the drugmaker to store large amounts of the shot at ultracold temperatures, South China Morning Post reports. Meanwhile, some experts raised concerns that cold-chain hurdles associated with Pfizer's product may outweigh the potential benefits in China.
Meanwhile, Fosun snared a green light from China's National Medical Products Administration to run a phase 2 trial of Pfizer and BioNTech's mRNA-based vaccine hopeful in-country.
And Israel secured 8 million doses of Pfizer's shot—enough to vaccinate around half of the country's population of 9 million—Prime Minister Benjamin Netanyahu said. Pfizer confirmed Thursday a deal was in the works but did not divulge financial details. Deliveries are expected to start in January if the shot wins out in the clinic, Netanyahu said. Israel also has an agreement with Moderna for future purchase of its mRNA-based candidate.
Switzerland's drug regulator Swissmedic kicked off a rolling review of Moderna's vaccine candidate, mRNA-1273, potentially teeing up a swift approval for the Massachusetts-based biotech's shot. The process will allow Swissmedic to screen data from ongoing clinical trials as soon as it becomes available. Moderna last month completed enrollment for its phase 3 vaccine study and yesterday announced it had accrued enough cases for the first interim analysis.
The U.K. is weighing whether to tap U.S. data analytics company Palantir to improve the country's struggling contact tracing program, which has been hit with IT glitches, slow testing turnaround, user errors and more since its launch. The move could prove controversial, however; civil liberties groups have knocked Palantir for its work with the U.S. immigration service and for its links to national security agencies; the optics of the company handling hundreds of thousands of personal case contacts per week "are just not good," a person familiar with the talks told the Financial Times.
Synairgen's inhaled formulation of interferon beta-1a was well-tolerated in hospitalized COVID-19 patients and led to greater odds of recovery than placebo, and more quickly, too, the company said in a release. One hundred and one patients received either the drug or placebo once daily for 14 days. Those on Synairgen's drug, dubbed SNG001, were also more likely to recover to "no limitation of activity" during treatment, the drugmaker said. Story
Hungary is set to receive a sample of Russia's controversial vaccine within a week-and-a-half for laboratory testing, with plans to kick off clinical studies in December, the country's minister of foreign affairs and trade said. If all goes to plan, Hungary would become the first EU member state to trial Russia's shot. The United Arab Emirates, Saudi Arabia, Indonesia, the Philippines, India, Brazil, Mexico and former Soviet republics have so far expressed interest in the vaccine.
And Russia on Wednesday said its shot candidate, Sputnik V, has so far shown 92% efficacy in a late-stage trial. The data are based on the first 16,000 patients who received either the shot or placebo in Russia's 40,000-person phase 3. Researchers were able to confirm 20 COVID-19 cases among that group, split between those given the vaccine and the control arm. The results are set to be published in a peer-reviewed journal, Russia's sovereign wealth fund said.
UPDATED: Thursday, Nov. 12 at 3:15 p.m. ET
While mRNA vaccines from Pfizer and Moderna are already in phase 3, German biotech CureVac is touting a storage advantage for its midstage candidate. The late-stage shots require storage at subzero temperatures, complicating distribution and use, while CureVac's candidate can be kept at refrigerated temperatures. Story
Incorporating GlaxoSmithKline's adjuvant technology, Canadian biotech Medicago pushed its COVID-19 vaccine into phase 3 testing. The plant-derived vaccine candidate recently succeeded in a phase 1 trial, but it'll now face a bigger and more important study. Story
A few days after Eli Lilly scored an FDA emergency use authorization for bamlanivimab, analysts are concerned the med's restrictive label may shrink sales of that medicine and Regeneron's antibody, which is under FDA emergency consideration. Story
Johnson & Johnson, in phase 3 testing with its COVID-19 vaccine, is well on its way to producing 1 billion doses in 2021 as planned and is looking ahead to 2022, VP of strategic initiatives Paul Lefebvre said in an interview. While manufacturing has set back some players, the company took a deliberate approach in preparing to deliver on its lofty goals. Story
The early data for Pfizer and BioNTech's mRNA vaccine candidate "open the floodgates" for the vaccine technology for infectious diseases, SVB Leerink analyst Daina Graybosch said in an interview. But that doesn't mean the tech will succeed in other disease areas. Story
UPDATED: Thursday, Nov. 12 at 9:22 a.m. ET
Moderna hit the needed number of patient infections in its phase 3 vaccine trial to move ahead with the first interim analysis. Because of a significant uptick in observed COVID cases across trial sites last week, the drugmaker expects its first data analysis to cover substantially more than 53 cases—the target required to kick off an initial review of its mRNA shot.
AstraZeneca's cancer med Calquence failed to help patients hospitalized with respiratory symptoms of COVID-19, the drugmaker said in a release. The BTK inhibitor missed its primary endpoint in the drugmaker's phase 2 to "increase the proportion of patients who remained alive and free of respiratory failure." No new safety signals arose, AZ said.
In the race for a vaccine, drugmakers aren't competing with one another, but against the virus itself, Johnson & Johnson CEO Alex Gorsky said. "The best possible position we could be in is where we have four or five or six of these vaccines available in the year 2021," he said. Gorsky said that mounting case numbers underline the importance of sustained efforts to prevent the virus' spread, adding that the pandemic has exposed a need to improve public health worldwide.
Amgen and Japanese drugmaker Eisai signed on to University of Pittsburgh Medical Center trial aiming to use artificial intelligence to assess and adjust COVID-19 treatments. Amgen's newly acquired Otezla (apremilast) and Eisai's experimental eritoran—both anti-inflammatory drugs—will be evaluated by reinforcement learning, a type of AI that can modify treatment protocols in real time according to data on each patient's reaction to the drug.
Meanwhile, Serum Institute of India completed enrollment for its phase 3 trial of AstraZeneca's vaccine candidate, the company said in a statement. The Institute has so far produced 40 million doses of the shot. AZ's vaccine is the 'most advanced' shot in clinical testing in the country, the Indian Council of Medical Research said.
Médecins Sans Frontières (MSF) wants governments to push drugmakers to open the books on their vaccine licensing deals so that the public, countries and treatment providers can secure shots at a fair price. “As long as we don’t know what’s in these deals, pharma will continue to hold the power to decide who gets access when, and at what price,” said Kate Elder, senior vaccines policy advisor for MSF's Acces Campaign. The current lack of transparency puts equitable access to a COVID-19 vaccine "in jeopardy," she added.
A viral mutation could dampen hopes for the leading pack of vaccines, which tackle the current version of the virus, Bloomberg analyst Sam Fazeli wrote in an op-ed. He cited Denmark's recent culling of its mink population after the virus spread through the animals and mutated before jumping back into humans. Meanwhile, mutations could easily crop up in people too, if the virus continues to spread unchecked.
Mallinckrodt is teaming up with Pharmerit to run a retrospective chart review study assessing its INOmax nitric oxide gas as an inhalation therapy for patients with COVID-19 respiratory complications. The drug is approved to treat respiratory failure associated with pulmonary hypertension in infants. The partners will collect data from around 200 hospitalized patients treated with INOmax for at least 24 hours between January 1 and July 31 of this year.
UPDATED: Wednesday, Nov. 11 at 3:00 p.m. ET
Vaccines from Johnson & Johnson and Sanofi and Novavax may be better suited to global distribution than Pfizer's candidate, which requires two doses and ultracold storage. J&J's shot, in testing at a single dose, is expected to remain stable for two years at minus 20 degrees Celsius and for upward of three months at refrigerator temps. Meanwhile, Sanofi and GSK's two-dose recombinant protein vaccine can be stored at 35.6 to 46.4 degrees Fahrenheit, a spokeswoman said. Story
Pfizer is already weighing options for a second-generation version of its vaccine, including a powder formulation that could eliminate the need for ultracold storage, chief scientific officer Mikael Dolsten told Business Insider. That formulation, storable via refrigeration, could roll out as early as next year, he added. Story
On Monday, as strong efficacy data on Pfizer's shot raised the company's shares nearly 8%, CEO Albert Bourla sold off 132,508 shares, more than 60% of his total holdings, for $5.6 million. Bourla sold the shares under a SEC rule that allows company insiders to arrange stock sales in advance, before they have access to "material nonpublic information." Story
Kaiser Health News posed a slate of questions about Pfizer's vaccine after Monday's data reveal. The length of immunity conferred by the shot and its efficacy in at-risk groups topped the list. KHN also wondered whether a quick authorization could derail ongoing trials of other candidates, among other things.
More than a few people are struggling with the name for Eli Lilly's antibody therapy bamlanivimab, which won an emergency OK on Tuesday in non-hospitalized COVID patients at high risk of severe disease. The tongue-twisting drug name even received some gentle ribbing on Fallon Tonight:
Meanwhile, Qiagen teamed up with cell therapy-focused startup TScan Therapeutics to develop a COVID-19 diagnostic designed to offer a comprehensive profile of a person's immune response to the disease. TScan will pivot its genome-based, high throughput discovery platform for parsing T-cell receptors to determine how those immune cells react to COVID-19. By focusing on T cells rather than antibodies—which may diminish over time—TScan figures its test could offer a more reliable way to screen for the virus over a longer period after infection. Story
UPDATED: Wednesday, Nov. 11 at 9:30 a.m. ET
Pfizer and BioNTech clinched a deal to supply 200 million doses of their experimental vaccine to the EU, with an option for another 100 million doses. The partners will crank out shots at BioNTech's German manufacturing sites and Pfizer's production site in Belgium, and aim to start deliveries by year-end, should the vaccine pass muster in the clinic. Story
And if everything goes to plan with Pfizer's data submission, the U.S. could start immunizing people in December, Health Secretary Alex Azar said. Pfizer expects to have safety data for an emergency nod as early as next week. After authorization, the U.S. would receive around 20 million doses per month and aim to vaccinate nursing home residents, healthcare workers and first responders by the end of January.
WHO director general Tedros Ghebreyesus welcomed "promising news" on the efficacy of Pfizer and BioNTech's vaccine, while reiterating the agency's commitment to fair distribution of an eventual shot. Ultracold storage requirements for the partners' mRNA-based vaccine have raised concerns about access in low- and middle-income regions. Meanwhile, the shot "presages significant cold-chain challenges for African countries," the WHO's regional director for Africa said.
And the Indian government ought to hammer out a vaccine distribution strategy to ensure Pfizer's shot is made widely available, lawmaker Rahul Gandhi said Wednesday. For its part, Pfizer is "exploring opportunities" to make the shot available in-country, the drugmaker told Business Standard. The country's health secretary confirmed India was in talks with Pfizer and said it could could strengthen its cold-chain capacity for the vaccine.
Rural hospitals in the U.S. also lack funds to secure the ultracold freezers needed to store Pfizer's vaccine, Stat reports. The CDC has recommended against state health departments purchasing the high-end freezers, given that other shots with less stringent storage requirements are likely on the way. Meanwhile, areas with smaller populations may struggle to use up Pfizer's 1,000-to-5,000 dose shipments before they expire. Pfizer, for its part, is working on smaller-dose shipments for 2021.
Plus, states say they still lack government funding necessary to meet widespread vaccination goals in the U.S. The CDC in September announced $200 million in grants designed to support shot planning, while organizations representing state health officials and immunization managers have called for around $8.4 billion more, the Chicago Tribune reports. Among the mounting costs states will face? Securing ultracold freezers, setting up and staffing vaccination centers, running vaccination messaging campaigns and more.
Meanwhile, the technology behind Pfizer and BioNTech's vaccine may have lasting effects beyond the COVID-19 pandemic. "It provides a glidepath for using mRNA technology for other vaccines, including cancer, autoimmune disorders, and other infectious diseases, as well as vehicles for genetic therapies," said Peter Hotez, vaccine researcher and dean at Baylor's National School of Tropical Medicine. "It really does help accelerate the whole biomedical field."
New daily cases in the U.S. passed 139,000 yesterday as COVID-19 hospitalizations hit an all-time high of 61,964, The New York Times reports. The country is now averaging more than 111,000 new cases per day, according to The Times' database.
UPDATED: Tuesday, Nov. 10 at 3:12 p.m. ET
CureVac, advancing an mRNA vaccine candidate, unveiled more data showing that the vaccine triggers potentially protective immune responses. Still it isn't known whether the vaccine can match the high efficacy bar just hit by Pfizer and BioNTech's vaccine in interim data, and tolerability questions linger. Story
After Pfizer unveiled positive interim findings for its mRNA vaccine Monday, HHS secretary Alex Azar said in network interviews the government has plans in place to begin vaccinations next month and into January, contingent on a review of the data and regulatory recommendations. Reuters story
Four months after launching, Massachusetts biotech Adagio Therapeutics scored an $80 million series B to push its COVID-19 antibody into the clinic next year. FierceBiotech story
UPDATED: Tuesday, Nov. 10 at 9:15 a.m. ET
Amid ongoing hype—and questioning—about Pfizer's vaccine results, CEO Albert Bourla told CNBC he'd be willing to get the vaccine first to ease concerns about its risk-benefit profile—but he's not sure that would be ethical given other populations might need it more. Forbes story
Pfizer partnered with Germany's BioNTech to advance the vaccine, which was originally developed by the husband-and-wife duo of Ugur Sahin and Oezlem Tuereci. Both are the children of Turkish immigrants. Reuters story
As it was advancing the program, Pfizer prioritized transparency, diversity and funding independence. There are numerous reasons behind those decisions, including vaccine skepticism, a failed historical experiment and more, outlined in a new Marketplace article.
Since Pfizer unveiled the results in a Monday press release, scientists have been pushing for more details. The "encouraging" figures are still the "earliest of results possible," Mayo Clinic vaccine researcher Gregory Poland told Reuters. It also isn't clear yet how well the vaccine protects older trial participants, whether it reduces severe disease or how long protection lasts. Another vaccine expert, Peter Hotez, told Science it's "always hard to read the tea leaves of a company press release." Reuters story | Calgary Herald story | Science story
While the vaccine data are "very good news," science writer Laurie Garrett pointed out that serious concerns remain, including the pandemic's current resurgence in the U.S. and the lame-duck leadership in federal government. Plus, there's much more to learn about the vaccine given the current state of the research.
President Donald Trump on Twitter alleged Pfizer waited to share the early data until after the election. Bourla, for his part, told CNN the company delivered the news "when the science told us the data was available." Business Insider story
The vaccine is expected to reach different countries at different time. India's Economic Times reports that country won't see it "anytime soon" and that ultracold temperature requirements would make it tough for a national immunization strategy there. The U.S., U.K. and other countries have placed advanced orders, the report says. Story
In China, Fosun Pharma's stock price soared after the news on hopes that the company will be able to launch the shot there. The drugmaker is partnered with BioNTech and may be able to launch after a bridging study, the South China Morning Post reports.
After efforts to re-purpose medicines and manufacture needed drugs to help fight the pandemic, Africa's Aspen is pivoting to focus on vaccines. The company recently signed on to help manufacture Johnson & Johnson's candidate. Bloomberg story
UPDATED: Monday, Nov. 9 at 3:28 p.m. ET
After Pfizer reported promising efficacy data for its vaccine, experts and analysts started weighing how other companies might fare with their own programs. Because Moderna is also advancing an mRNA program, the company is in a solid position with its mRNA-1273, experts said.
The Pfizer results "provide strong validation" of the mRNA vaccine platform, Chardan analyst Geulah Livshits wrote to clients. The biotech's vaccine has less restrictive cold chain requirements than Pfizer's does, so its program wouldn't necessarily need to meet the 90% efficacy mark to be used widely, the analyst wrote. In all, the Pfizer news is an "important positive read-across" for Moderna given the biotech's significant investment in its mRNA vaccine franchise.
Anthony Fauci, director of the NIAID, also said the Pfizer news bodes well for Moderna. Speaking with Stat, Fauci said Moderna "will likely have similar results."
Still, Evercore ISI analyst Josh Schimmer said the mRNA vaccines take longer to scale up than the subunit adjuvant program at Novavax and the viral vector program from AstraZeneca. The "right mix of approved vaccines" could mean adequate supply for the U.S. and well beyond" by next year's first quarter, he said. But if it's all up to mRNA vaccine players to deliver the needed doses, it could be the third quarter before adequate supplies are available.
Meanwhile, positive vaccine news could raise questions for companies working on leading COVID-19 therapeutics. Gilead, Eli Lilly and Regeneron are key players, and Barclays analysts wrote that the Pfizer news “should raise further questions around the mid-to-long-term durability" of revenue from potential coronavirus therapeutics. The analysts noted that drugs will still be needed even after vaccines launch. Story
UPDATED: Monday, Nov. 9 at 9:23 a.m. ET
Pfizer and BioNTech's vaccine candidate, BNT162b2, boasted more than 90% efficacy in preventing COVID-19 in patients without prior evidence of infection, interim data from the partners' phase 3 showed. That number could change as more data roll in, Pfizer said. The interim analysis covered 94 patients; the company will need to submit data on 164 patients and build up at least two months' worth of safety data before it can file for an emergency nod, potentially around Thanksgiving. Story
Novavax's recombinant nanoparticle-based vaccine won fast track designation from the U.S. Food and Drug Administration. The drugmaker aims to kick off late-stage trials in the U.S. and Mexico by the end of November and expects an ongoing phase 3 in the U.K. to complete enrollment in that same timeframe. Interim data from that trial could be ready as early as the first quarter of 2021, Novavax said.
President-elect Joe Biden plans to convene a 12-member coronavirus task force Monday, led by former surgeon general Vivek Murthy and ex-FDA commissioner David Kessler. Biden has already set forward a number of COVID-19 goals, including doubling the number of drive-through testing sites, establishing a U.S. public health job corps and boosting production of masks, face shields and other protective equipment.
Plus, some Biden advisers have already met with drug and vaccine makers that are part of the government's Warp Speed program, Bloomberg reports. According to the news service's sources, advisers told the companies that his administration wouldn't want to disrupt the program's work in getting new drugs and vaccines to market. Instead, it wants to be ready to help when Biden moves into the Oval Office.
Serum Institute of India has produced up to 30 million vials of AstraZeneca's vaccine hopeful, dubbed Covishield in-country, the joint commissioner of the Pune division of the Food and Drug Administration said. The company is now seeking an emergency license for the shot. Results from an Indian phase 3 are expected by year-end, and Serum Institute has kicked off production to meet demand ahead of an authorization.
Meanwhile, AstraZeneca agreed to supply around 22 million vaccine doses to Argentina, with plans to start distributing the shots in the first half of 2021. That delivery timeframe is subject to the success of ongoing trials and local regulatory approval, AZ said in a statement circulated by the Argentine government Saturday.
Sanofi, Eli Lilly Korea and Roche Korea are tapping their early retirement programs to scale back sales forces amid the COVID-19 outbreak, Korea Biomedical Review reported. The move comes as more drugmakers turn to digital sales tools—a transition already in the works back in 2019 and accelerated by the pandemic. Specifically, Sanofi plans to encourage some of its chronic disease sales reps to choose early retirement, while Lilly aims to dial back drug reps in the country by 20%.
UPDATED: Friday, Nov. 6 at 9:19 a.m. ET
Novartis' arthritis med Ilaris, also known as canakinumab, failed to keep seriously ill patients off ventilators and didn't beat standard of care at preventing deaths, phase 3 data showed. The trial tested the drug in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome. Novartis is also testing Jakafi against the disease and joined forces with Molecular Partners in October to develop two DARPin therapies as potential treatments.
AstraZeneca plans to bring ex-U.S. vaccine data before the FDA once it obtains results from its British, South African or Brazilian trials—even if those data precede a readout from the drugmaker's U.S. phase 3, EVP of biopharmaceuticals R&D Mene Pangalos told Reuters. The FDA has set expectations for safety and efficacy, but hasn't said those data must come from U.S. studies, Pangalos said, adding that an approval would be unlikely to disrupt its ongoing stateside trial.
The U.K.'s Recovery Trial on Friday started investigating aspirin to see whether the cheap and widely-available drug could reduce the risk of blood clots in hospitalized COVID patients. The trial expects to dose at least 2,000 patients with aspirin plus standard of care and will primarily assess mortality after 28 days. The researchers are also curious whether the drug can reduce the length of hospitalization and need for ventilation.
Regeneron is optimistic the FDA will authorize its antibody cocktail but still doesn't know the timeline for that decision, CEO Leonard Schleifer said on a Thursday earnings call. The company earlier this year said clinical data showed the drug reduced medical visits in patients with mild or moderate disease. Regeneron could make about 80,000 doses available by the end of this month and have 300,000 doses ready by the end of January, the company said. Story
Amgen staffers who have worked remotely since March will continue to work from home until the end of June 2021, Judy Brown, SVP and site head at Amgen's global headquarters, said in an email obtained by Acorn. Brown reasoned that the Greater Los Angeles area, where the company is based, is unlikely to see a drop in cases before spring, adding that a vaccine probably wouldn't become available during that timeframe, either.
UPDATED: Thursday, Nov. 5 at 3:55 p.m. ET
Hologic's revenue may have slipped last quarter, but its COVID-19 testing business has continued to soar, helping the company net more than $1.3 billion in sales in the final quarter of its 2020 fiscal year. The company's molecular diagnostics division alone managed to pull $818.9 million for the period—almost as much as the $865.8 million in total revenues Hologic made during the last quarter of 2019. Story
Children with COVID-19 produce fewer, weaker antibodies than adults, a study published in Nature Immunology found. While both adults and children in the study produced COVID-19 antibodies, children mainly produced one kind, called IgG, which binds to the virus' spike protein. Adults, meanwhile, made multiple types of antibodies—better than IgG at neutralizing the virus—that bound to the spike protein and other viral proteins, too.
Contract research organization Parexel teamed up with bioanalytics firm Synexa Life Sciences and blood-drawing specialist Drawbridge Health to offer Synexa's serology test, which can help identify whether a person has had a virus such as SARS-CoV-2, and Drawbridge's OneDraw remote blood collection device to customers as part of the company's myriad COVID-19 projects and trials. Parexel cited an "urgent need" for accurate serology testing that also limits risk of exposure to COVID-19—which it thinks its new pact can deliver on. Story
The time has come for the U.S. to develop a testing strategy to track asymptomatic spread of COVID-19, CDC director Robert Redfield said. The CDC in August issued a recommendation that people who had come into close contact with an infected person didn't necessarily need to get tested unless they were at higher risk of infection or severe disease. The agency changed its tune in September, urging anyone who has been in close contact with an infected individual to get tested, even if they don't display symptoms.
An oversight panel called for changes at the World Health Organization, stressing that it was essential the agency maintain "neutrality and political independence." The panel urged the U.N. agency to establish a graded system to "alert and engage the wider international community at an earlier stage in a health crisis," and also said the WHO's Emergency Program is in "a constant struggle to mobilize resources, with staff forced to juggle competing priorities simultaneously."
UPDATED: Thursday, Nov. 5 at 9:30 a.m. ET
AstraZeneca is poised to supply "hundreds of millions" of vaccine doses on a rolling basis once its shot is authorized, CEO Pascal Soriot told Bloomberg, despite delays in early U.K. shipments. Soriot added that a recent resurgence in cases had enabled scientists to gather necessary clinical data. A day earlier, Kate Bingham, chair of the UK Vaccine Taskforce, had said just 4 million AZ doses would be ready by year-end in the U.K., rather than the 30 million doses the drugmaker had hoped to deliver by September.
Chile's drug regulator green lighted a clinical trial of AstraZeneca's vaccine, the country's President, Sebastian Pinera, said. The AZ study joins a Chilean trial of Johnson & Johnson's shot, plus a separate test of Sinovac's pandemic hopeful. The country has penned a deal for 10 million doses of Pfizer and BioNTech's shot and is looking to ink similar agreements with AstraZeneca, J&J and Sinovac, Pinera said. Elsewhere, Peru said J&J and AZ would kick off vaccine trials in the country next week.
And Bangladesh locked down 30 million AstraZeneca doses through Serum Institute of India (SII). The country will purchase 5 million doses from SII per month through Bangladeshi drugmaker Beximco, provided the shot is cleared by regulators, the country's health minister said.
The World Health Organization is going all-in on monoclonal antibodies, dexamethasone and repurposed meds—but not Gilead's Veklury (remdesivir)—in its scheme to provide COVID-19 drugs to low-income countries, an internal document obtained by Reuters showed. Unitaid, a health partnership co-leading the effort, confirmed that the scheme would not include Veklury, though it didn't comment on the reason for excluding the antiviral. A WHO trial reported in October found Gilead's drug offered little benefit in COVID-19 patients; Gilead has disputed those findings.
The U.S. charted more than 107,800 new COVID-19 cases Wednesday, according to The New York Times, setting a grim record for daily infections. Meanwhile, Maine, Minnesota, Indiana, Nebraska and Colorado also hit single-day case records.
Bharat Biotech could launch its shot as early as February, jumping ahead of its previously stated second-quarter rollout goal, a senior scientist at the Indian Council of Medical Research (ICMR) told Reuters. Bharat plans to kick off a late-stage study of its shot, Covaxin, this month. “It is expected that by the beginning of next year, February or March, something would be available," he added.
UPDATED: Wednesday, Nov. 4 at 3:00 p.m. ET
Britain will receive an estimated 4 million doses of AstraZeneca's vaccine by year-end, rather than the 30 million doses AZ had hoped to supply by September, UK Vaccine Taskforce chief Kate Bingham told lawmakers Wednesday. Earlier in the day, the chief investigator of the University of Oxford's vaccine trial said he was "optimistic" that AZ could deliver late-stage trial data before year-end, adding that doses were already in production. The U.K. in May penned a deal for 100 million doses of AZ's shot, which should now be available in the first half of 2021, Bingham said.
Russia aims to provide its citizens with tens of millions of doses of its Sputnik V vaccine by year-end, but production and quality control hurdles may deflate that number, The Bell reported. "We can't stabilize the vaccine, no one yet can," an unnamed exec at one of the Gamaleya Institute's four Russian manufacturing partners told the news outlet. Meanwhile, vaccine batches frequently miss the institute's quality control bar and attempts to launch bioreactors at scale have been "generally unsuccessful."
A COVID-19 breathalyzer test from Singapore's Breathonix achieved at least 90% accuracy when screening participants on-site for 60 seconds, the company said. An ongoing pilot study in 180 people showed an overall sensitivity of 93% and a specificity of 95%. The test, which uses a one-way valve and disposable mouthpiece, could be used for mass screening in high-traffic areas, Breathonix figures. Story
BD inked a contract with the Dutch Ministry of Health to supply an initial 1.2 million units of its rapid antigen diagnostic, the hand-held Veritor Plus system, this month, with another 8 million slated for delivery to the Netherlands by June of next year. The portable, point-of-care system won an emergency coronavirus nod from the FDA in July and a CE mark in September. Story
The FDA on Tuesday warned healthcare professionals that antigen tests could deliver false positives if users fail to follow instructions. The regulator encouraged labs to perform follow-up testing with a molecular assay when appropriate and cautioned that improper storage, failure to read testing results at the correct time and cross-contamination could all lead to inaccurate readouts. The warning follows reports of false positives from antigen tests in nursing homes and other healthcare settings.
UPDATED: Wednesday, Nov. 4 at 9:12 a.m. ET
Australia locked down 40 million vaccine doses from Novavax, plus 10 million doses from Pfizer and BioNTech, bringing the country's total vaccine investment up to more than $3.2 billion. If the shots win approval, they're expected to become available in Australia during the first half of 2021. The country earlier this year secured doses from AstraZeneca and the University of Queensland.
China's Fosun Pharma stopped development on BioNTech's first COVID-19 vaccine and will instead seek Chinese approval for the German shot maker's second candidate, currently in late-stage testing in the U.S. Fosun aims to run a bridging study that may enable it to use global data on the second candidate, BNT162b2. Pfizer and BioNTech chose that shot as their phase 2/3 candidate after it turned up a lower rate of side effects than their first prospect. Story
Speaking of Pfizer and BioNTech, the chair of the UK Vaccine Taskforce, Kate Bingham, is hopeful that strong interim data from the mRNA partners, plus AstraZeneca and the University of Oxford, will emerge in early December, potentially teeing up a vaccine rollout before year-end.
For its part, the University of Oxford is "optimistic" that it could unveil late-stage results on its AstraZeneca-partnered shot this year, said chief investigator of the university's vaccine trial, Andrew Pollard. As for whether the shot might be available before Christmas, "[there] is a small chance of that being possible but I just don't know," he said, adding that a shot would not be a panacea. “We will still have people getting this virus because it is just too good at transmitting.” Story
In people with symptomatic COVID-19, Quidel's rapid Sofia test was able to detect more than 80% of cases found by the slower, gold-standard PCR test—but when Quidel's test was used to randomly screen asymptomatic patients, it only picked up 32% of infections caught by the PCR method, a University of Arizona study found. It's possible the rapid test missed asymptomatic cases ID'd by the lab test because those people were carrying too little of the virus to spread it to others, one study author said.
The U.S. FDA ordered NovaBay Pharmaceuticals to stop claiming that its Avenova antimicrobial eyelid and eyelash spray can kill the SARS-CoV-2 virus. The company's website asserts that "an independent third-party laboratory study" confirmed its spray can fully inactivate the virus and recommends using it to eliminate airborne respiratory droplets. In a warning letter, the FDA pointed out that the NovaBay spray has no human data to back it up.
UPDATED: Tuesday, Nov. 3 at 3:16 p.m. ET
While most vaccine makers will pass their shots off to McKesson for U.S. distribution, Pfizer is taking matters into its own hands, Tanya Alcorn, VP for biopharma global supply chain at the company, said. Pfizer has developed a GPS and temperature-tracked thermal cooler to help transport its vaccine, along with a control tower that provides real-time alerts if temperatures deviate or a shipment runs late. Still, some officials remain concerned that vaccination centers won't have the cold-storage capabilities to house Pfizer's shot. Story
T cell immunity to the coronavirus may outlast antibodies in patients who've recovered from COVID-19, a recent U.K. study showed. Analyzing the blood of 100 patients six months after they had asymptomatic or mild disease, researchers found that while antibody levels dropped in some patients, T cell response endured. T cell response was also higher in patients who displayed symptoms while infected.
61,000 new coronavirus cases cropped up in children last week, more than any previous week in the pandemic, the American Academy of Pediatrics (AAP) reported. Severe illness due to COVID-19 in children is rare, but there is an "urgent need" to collect more data on the long-term impact of the disease in kids, AAP said.
Colorado State University is using the fecal matter and pooled spit of undergraduates to catch COVID-19 cases early, Kaiser Health News reports. The school's sewage review follows emerging research suggesting people shed the virus in feces early in their infections. The school is also conducting "paired" pooling of saliva samples, which allows testing of multiple samples at once without the need for much retesting if a pool of samples turns up positive.
UPDATED: Tuesday, Nov. 3 at 9:30 a.m. ET
Advocacy group Public Citizen urged Gilead Sciences to give up the priority review voucher it earned alongside its FDA approval of Veklury, also known as remdesivir. The voucher can be used to speed up FDA review time for another drug or sold—and previous sales have netted hundreds of millions of dollars. Public Citizen called the incentive "unnecessary" and "inappropriate" given Gilead's expected Veklury sales. Story
The Coalition for Epidemic Preparedness Innovations (CEPI) will fund development of Clover Biopharmaceuticals' protein-based S-Trimer vaccine through a global phase 2/3 trial, bringing its total investment in the program to upward of $328 million. Beyond the upcoming efficacy trial, pegged to start before year-end, CEPI's investment will fund studies in people with autoimmune conditions, children, pregnant women and more. If the shot clears the clinic, Clover and CEPI aim to make hundreds of millions of doses available per year through the WHO's Covax effort. Story
Israel dosed the first two patients in a phase 1 trial of its coronavirus vaccine, Brilife, developed by the Israel Institute for Biological Research. A phase 2 trial that seeks to enroll 960 healthy volunteers is expected to kick off in December, while a 30,000-person phase 3 is pegged to start in April or May 2021 if warranted.
The pandemic is entering a new, "deadly phase," White House coronavirus coordinator Deborah Birx said in a private memo to White House officials obtained by The Washington Post. Birx called for consistent messaging about masks, hand-washing and social distancing. It's not about lockdowns, she wrote, but rather, "an aggressive balanced approach that is not being implemented.” Her comments put her at odds with President Donald Trump, who says the nation is "rounding the corner" on the pandemic.
Scientists at the University of Washington School of Medicine developed a nanoparticle vaccine candidate that sparked neutralizing antibody levels in mice ten times higher than those seen in recovered patients—and at a much lower dose than required for vaccination with the SARS-CoV-2 spike protein. The University licensed its candidate to Icosavax for further study. Amgen agreed to manufacture a key intermediate for initial R&D while South Korea's SK Bioscience advances its own studies on the shot.
South Korea's new minister for food and drug safety, Kim Gang-lip, made his first goal to "mobilize our regulatory capacity as much as possible to help develop a Covid-19 treatment and vaccine that people can trust.” Kim also aims to boost the Korean drug regulator's global competitiveness and is seeking "international regulatory harmonization."
UPDATED: Monday, Nov. 2 at 3:20 a.m. ET
CureVac aims to build an mRNA vaccine that generates a balanced immune response similar to the body's natural reaction, and now it's armed with interim phase 1 data supporting that goal. In the dose escalation study, CureVac's highest 12-microgram dose—pegged to advance into a phase 2b/3—raised binding and neutralizing antibody levels to those seen in a set of 67 seriously ill COVID-19 patients, the company said. Story
Pfizer and Bristol Myers Squibb launched a new campaign to promote doctor visits amid the pandemic. "No Time to Wait," which covers broadcast and streaming TV and radio, as well as digital and social media, focuses on three conditions: atrial fibrillation, deep vein thrombosis and pulmonary embolism, all treated by the partner's anticoagulant Eliquis. Story
Johnson & Johnson's weekly video series, "The Road to a Vaccine," has racked up more than 100 million views since launching in April. Hosted by journalist Lisa Ling, the show features J&J researchers and execs, public health officials and advocates in conversation about vaccine development, mental health, racial disparities and more. “At the end of the day, science is about society, and society has to understand the processes of science,”J&J communications exec Seema Kumar said of the series during Fierce Pharma Marketing’s Digital Pharma Innovation Week. Story
Massachusetts-based biotech incubator LabCentral, together with lab facility provider BioLabs, launched the Cambridge Consortium for Rapid COVID-19 Tests (CCRCT) to assess and validate COVID-19 diagnostics that people can use at home. CCRCT last month started a trial of a 15-minute, self-administered antigen test made by LabCentral alum E25Bio. Story
Hologic snared a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, with the goal to provide 13 million COVID tests per month by January 2022. The company's Panther Fusion and Aptima SARS-CoV-2 assays won emergency nods in March and May, respectively, and the FDA in September OK'd Hologic's Panther Fusion test to screen asymptomatic patients. Story
Novavax inked a 15-year lease for about 122,000-square-feet of offices in Gaithersburg, Maryland, for manufacturing, office space and R&D, while an affiliate of the company bought 9.7 acres in Gaithersburg for future development. Novavax has scored up to $2 billion from the U.S. government and CEPI for its COVID-19 vaccine program; the company's shot is currently in late-stage testing in the U.K. and a large phase 3 trial in the U.S. and Mexico is set to kick off later this month. Story
Fifty-nine percent of Russians say they wouldn't get the country's Sputnik V vaccine, an October poll from Russia's Levada Center showed. That number rose from 54% of respondents unwilling to get the shot in August. Meanwhile, just 31% of people polled in October said they would get the shot, down nearly nine percentage points from August. Levada polled 1,601 Russians between Oct. 22 and Oct. 28.
UPDATED: Monday, Nov. 2 at 9:15 a.m. ET
Johnson & Johnson hopes to start testing its vaccine in children ages 12 to 18 as soon as possible, said Jerry Sadoff, a vaccine research scientist at J&J's Janssen unit. The company could eventually test its shot in even younger children, Sadoff said. The vaccine platform J&J's using for its COVID-19 shot, AdVac, is also used in an Ebola vaccine that's been given to infants, children and pregnant women.
Africa's biggest drugmaker, Aspen Pharmacare, struck a preliminary deal to produce Johnson & Johnson's vaccine in South Africa. The company would carry out manufacturing and packaging work at its Port Elizabeth plant, which boasts capacity for 300 million doses a year, if the shot snares regulatory approval in the country.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) awarded £1.5 million ($1.9 million) to GenPact for an artificial intelligence tool to process potential side effects and safety signals from an approved vaccine. Based on historical vaccination data, the MHRA expects to see between 50,000 and 100,000 side effect reports for every 100 million doses administered over a six to 12 month span.
Bharat Biotech aims to launch its vaccine hopeful in the second quarter of 2021, pending an approval in India, the company's executive director said. The shot, Covaxin, has a ways to go: Bharat expects to kick off recruitment for a phase 3 trial this month.
At a rally early Monday morning, President Donald Trump floated the possibility of firing the nation's top infectious disease expert, Anthony Fauci, after the election. During the event, Trump once again said the country has "turned the corner" on the pandemic. But in a Washington Post article published Saturday, Fauci said the U.S. "could not be positioned more poorly" ahead of the winter. Story
The U.S. needs to make an "abrupt change" in public health practices and behaviors to counter the pandemic, Anthony Fauci told The Washington Post. The coronavirus task force is meeting infrequently and has much less influence with the President now, Fauci said. And the NIAID chief said Scott Atlas, a neuroradiologist who has become Trump's favored pandemic advisor is "a smart guy who’s talking about things that I believe he doesn’t have any real insight or knowledge or experience in."
Meanwhile, Thanksgiving will be a COVID-19 "inflection point," former FDA commissioner Scott Gottlieb said. "There are about 23 states that are accelerating the spread right now," he added. It's unlikely that the entire country would lock down again, as Europe is doing, though Gottlieb said he expects states to take local action as hospitals become overwhelmed.
The U.K.'s Department for Business, Energy & Industrial Strategy came to the defense of Kate Bingham, chair of the country's vaccine task force, after The Sunday Times published an article alleging she had disclosed "sensitive" information about U.K. investments in COVID vaccines and therapeutics. Her presentation, for a U.S. women's conference, had been cleared by the government, the department said, and Bingham said little that experts at the conference couldn't deduce themselves.
Siberia-based drugmaker Pharmasyntez asked the Russian government for permission to produce a generic version of Gilead Sciences' Veklury, or remdesivir, despite lacking a patent or license. The drugmaker wrote to Gilead in July but did not hear back, and it is now asking the Russian government for a compulsory license, which would allow it to make a remdesivir generic without Gilead's OK.
Editor's note: This article was corrected to show that the Department for Business, Energy & Industrial Strategy, not BIA, issued the statement about Kate Bingham.