New data from the CDC show that the COVID-19 vaccines from Pfizer and Moderna dramatically cut hospitalizations in older adults. Europe is on track to reach herd immunity this summer, BioNTech's CEO said.
The worldwide case count stood at more than 148 million on Wednesday morning, with more than 3.1 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: Wednesday, April 28 at 3:25 p.m.
New real-world CDC data show that the Pfizer and Moderna mRNA vaccines cut hospitalizations for older adults by 94%. For those who are partially vaccinated, the risk of hospitalization is cut by 64%.
Europe has struggled to get its vaccination program off the ground, but now the region is set to reach herd immunity in three to four months, BioNTech CEO Uğur Şahin said on Wednesday.
The pandemic has changed how people work, and Pfizer is adapting. The company is putting its Philadelphia campus up for sale as it seeks to "provide more modern and flexible workspaces for our colleagues," Philly Voice reports. The Philadelphia Business Journal first reported the move.
UPDATED: Wednesday, April 28 at 8:55 a.m.
Blood testing company Versiti has put forward a suite of antibody tests to help identify patients at risk of developing potentially severe blood clots—known as cerebral venous sinus thrombosis. Medical providers typically use the blood thinner heparin to treat blood clots, but that medicine can actually make matters worse in patients carrying certain platelet-activating antibodies. The news follows international probes into the rare blood clots among recipients of Johnson & Johnson and AstraZeneca’s COVID-19 vaccines. Story
Lawyers for the European Union demanded AstraZeneca immediately begin delivering COVID-19 vaccines from two of its factories in Britain, which haven't been sending supplies to the EU so far, Reuters reports. The argument came during the opening hearing of the EU’s legal case against AstraZeneca for its short supply of doses to the bloc. The EU argues that AstraZeneca breached its contract by not providing doses from all four plants the company listed on its supply deal with the European Commission.
Nestlé employees in Switzerland were asked to temporarily help CDMO giant Lonza scale up production of Moderna’s COVID-19 vaccine after the drugmaker faced delays in its European supply chain, Reuters reports, citing state broadcaster RTS. The Swiss government made a call for “volunteers” to Nestlé research center employees who had until Monday to sign up for a three-month Lonza duty.
Ampio Pharmaceuticals said results from a phase 1 trial examining an inhaled version of its lead drug Ampion in COVID-19 patients with respiratory distress found a 78% reduction in death from any cause, meeting its primary endpoints. Ampio chief Michael Macaluso said the company would move forward with a double-blind placebo-controlled phase 2 trial immediately.
UPDATED: Tuesday, April 27 at 3:15 p.m.
Now that the U.S. has resumed its use of Johnson & Johnson’s COVID-19 vaccine, a new report from the CDC demonstrates just how important the shot can be when it comes to saving lives. According to the CDC’s model, between 580 and 1,400 COVID-19 deaths could be prevented in the next six months if the U.S. used the vaccine at half the rate at which it was used in early April, Business Insider reports. The shot could also prevent up to 9,400 hospital admissions, depending on the virus’ spread.
Pfizer CEO Albert Borla told CNBC that the company’s experimental oral antiviral could be available by the end of the year. The drug candidate, dubbed PF-07321332, entered early stage clinical trials in March and has already demonstrated “potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses,” Pfizer says. The drug is supposed to be taken early in disease onset without requiring hospitalization.
Jubilant Pharma has completed initial tests of its oral antiviral remdesivir formulation in healthy volunteers. While Jubilant has yet to share data from its safety and pharmacokinetic studies in animals and healthy volunteers, the company says the drug “is able to undergo absorption when administered using the novel oral formulation” and has a similar safety profile to the injectable formulation. Story
CDC Director Rochelle Walensky said the federal agency has not seen a link between COVID-19 vaccines and heart inflammation. The director’s comments come after the U.S. Department of Defense said it’s tracking 14 cases of heart inflammation, or myocarditis, among people who were vaccinated through the military's health services.
UPDATED: Tuesday, April 27 at 9:10 a.m.
India is expecting the largest share of the 60 million doses of AstraZeneca vaccine the U.S. plans to share globally, Reuters reports, citing two Indian government sources. The White House on Monday said it will send an initial 10 million doses “in coming weeks” with the remainder of the supply exported by June. One source told the news agency that India is vying for more than 35% of the stockpile.
Shares of drugmaker Eli Lilly dipped in premarket trading on Tuesday after the company reported lower-than-expected demand for its COVID-19 antibody drugs during the first quarter. Lilly chief David Ricks told CNBC that demand for the company’s therapies is tapering off now that vaccines are being rolled out in the U.S.
Gilead Sciences said it will donate a minimum of 450,000 vials of remdesivir, marketed as Veklury, to India, which is facing the world’s worst surge in COVID-19 infections. The company said it will also help its voluntary licensing partners scale up the drug’s production by supporting the addition of new local manufacturing facilities and donating active pharmaceutical ingredients (API).
Merck entered into non-exclusive voluntary licensing agreements with five generic manufacturers in India for its oral COVID-19 antiviral therapeutic, molnupiravir, currently in phase 3 trials. The company said the agreements would accelerate the drug’s availability in India and other low- and middle-income countries once it’s approved by local regulatory authorities.
UPDATED: Monday, April 26 at 3:02 p.m.
The Biden Administration said it will begin sharing its supply of AstraZeneca’s vaccine with other countries as soon as it’s cleared with federal regulators. The decision will clear the way for as many as 60 million doses to be shipped outside the U.S. in the coming months. The White House shared roughly 4 million doses with Canada and Mexico last month.
The World Health Organization will review Moderna’s vaccine for emergency-use listing on Friday. An endorsement would signal the shot's safety and effectiveness to national regulatory authorities globally, Reuters reports. The WHO’s committee of technical experts have so far granted emergency listings for vaccines from Pfizer, AstraZeneca and Johnson & Johnson.
The European Commission said it's launched legal action against AstraZeneca for failing to deliver its promised supply of COVID-19 vaccines and for not having a “reliable” plan to ensure timely deliveries, a spokesperson told Reuters. The EU said the decision was unanimous among the 27-member bloc. The lawsuit was first reported by Politico last week. Story
The head of Emergent BioSolutions, which has faced a series of PR crises since production issues at its Baltimore facility resulted in millions of wasted Johnson & Johnson vaccine doses, sold more than $10 million worth of company shares in January and early February, The Washington Post reports. The transactions—part of CEO Rober Kramer’s compensation package and made under a trading plan—came before the company’s stock fell from roughly $125 in mid-February to a low of $62 per share, a more than 50% decline. Story
UPDATED: Monday, April 26 at 11:32 a.m.
As it battles a brutal coronavirus wave, India will receive aid from the United States. In addition to providing essential raw materials to produce COVID-19 vaccines, the U.S. also will supply therapeutics, rapid diagnostic test kits, ventilators and personal protective equipment. The U.S. Development Finance Corporation also is funding an expansion of India’s BioE, which will allow for the production of 1 billion COVID-19 vaccine doses by the end of 2022. The announcement came amid appeals from some congressional leaders for the Biden administration to send the country’s surplus of AstraZeneca COVID-19 vaccines to India.
According to the Sunday Times, the U.K. is close to completing a deal with Pfizer-BioNTech to supply an additional 40 million doses of their COVID-19 vaccine which would be ready for those needing booster shots this fall. A government source told the Times that the extra doses could also be used as an alternative to the AstraZeneca vaccine when the country opens vaccinations to those in their 20s.
Moderna will receive manufacturing support from Sanofi in producing its COVID-19 vaccine that will help relieve supply problems for the shot. The company has warned several countries of a supply shortfall. Story
UPDATED: Friday, April 23 at 5:03 p.m.
The CDC’s Advisory Committee for Immunization Practices (ACIP) voted to continue the use of Johnson & Johnson’s vaccine in adults ages 18 and older in the U.S., although the shot will come with a new warning label regarding the rare cases of blood clots reported in some recipients. J&J’s shot has been halted across the U.S. since April 13 following the blood clot reports in six women. The FDA and CDC are likely to accept the panel's recommendation. Story
U.S. officials have pulled the plug on funding a phase 3 trial for Inovio’s COVID-19 vaccine, telling the company the the country doesn’t need another shot. Inovio was hoping to offer a vaccine that would be stable at room temperature for up to a year, a crucial attribute in the early days of vaccine development. Inovio will now seek a location outside of the U.S. to conduct a phase 3 trial for INO-4800 with Chinese partner Advaccine and the International Vaccine Institute. Story
Executives at a suite of COVID-19 heavyweights are raising flags about another pandemic resource in scarcity: people. Moderna CEO Stéphane Bancel said the Swiss CDMO it signed on to help produce its shot, Lonza, has struggled to hire enough specialized personnel for its vaccine production push. Story
UPDATED: Friday, April 23 at 9:10 a.m.
The CDC’s Advisory Committee for Immunization Practices (ACIP) will reconvene on Friday to consider how the U.S. should move forward with its use of Johnson & Johnson’s COVID-19 vaccine. The panel of outside experts decided to delay its decision last week while it assessed reported a handful of cases of a rare and severe type of blood clot.
The European Union signed a new supply deal with Pfizer and BioNTech for up to 1.8 billion doses of their mRNA vaccine, Reuters reports, citing an EU official. The two companies have already agreed to deliver 600 million doses to the bloc under two previous contracts.
Europe also signed off on a batch size increase for the Pfizer and BioNTech vaccine, allowing the partners to boost production. Officials also authorized a new filling line for Moderna's vaccine.
French drugmaker Valneva said it will no longer prioritize its supply deal with the European Commission and will instead try to ink agreements for its inactivated vaccine candidate on a country-by-country basis. Valneva, which entered into advanced discussions with the commission in January, said despite the vaccine’s recently published phase 1/2 trial data, the company has “not made meaningful progress” in its discussions with the EU.
The CDC is probing the death of an Oregon woman and the hospitalization of another woman in Texas after the pair received Johnson & Johnson's vaccine, Reuters reports, citing state health officials. The Oregon woman developed a blood clot while the Texas woman showed symptoms similar to those who previously suffered the rare clots. Officials warned the cases couldn’t be tied to J&J’s shot until the investigation concludes.
The World Health Organization’s vaccine advisers called for more data on cases of blood clots in people who received the AstraZeneca vaccine outside Europe. The WHO's Strategic Advisory Group of Experts (SAGE) said a link between the vaccine and the clotting cases is plausible, but remains unconfirmed.
India, facing the world’s worst coronavirus surge, reported a second daily record of new infections as hospitals beg the government for more oxygen to help COVID-19 patients struggling to breathe. The nation reported more than 332,700 new cases on Thursday and 2,263 new deaths, the Associated Press reports.
UPDATED: Thursday, April 22 at 3:00 p.m.
The World Health Organization said it will begin inspecting manufacturing practices for Russia’s COVID-19 vaccine, Sputnik V, alongside the European Medicines Agency beginning May 10. The inspections, which should conclude in June, are part of the vaccine’s application for emergency-use listing with the WHO.
Researchers with the CDC said an interim analysis of vaccine safety data showed no evidence the Pfizer-BioNTech or Moderna vaccines pose a serious risk to pregnant women, The New York Times reports. The preliminary findings, based on an analysis of more than 35,000 people who were vaccinated shortly before or during pregnancy, is the largest yet on the shots’ safety in pregnant people.
Britain’s medicines regulator identified 168 cases of major blood clots following the use of AstraZeneca’s vaccine, a rate of 7.9 clots per million doses administered, Reuters reports. While the latest figure marked a jump compared with last week, experts advise that the clots are still rare and the increase was expected given that cases are now being reported “reliably and quickly.”
Just days after receiving the FDA's blessing for its at-home COVID-19 test to be sold over the counter, Lucira Health is now offering the kits at no cost to NBA ticketholders heading to Golden State Warriors games. The company’s kit comes with a battery-powered testing device that can return results within 30 minutes. Story
UPDATED: Thursday, April 22 at 10:37 a.m.
The European Union is ready to launch legal action against AstraZeneca for failing to deliver on COVID-19 vaccine supply promises. In the first quarter, the company provided only 30 million of the 100 million doses that were pledged to the bloc. AZ’s recent projection for the second quarter is to supply 70 million doses, far short of the 300 million promised. The goal of the action is to eventually receive the pledged supplies, a source told Politico. Story
With its needs being fulfilled by other suppliers, Israel wants an incoming shipment of AstraZeneca COVID-19 vaccines to be delivered somewhere else. Agreements with Pfizer-BioNTech and Moderna are in place to supply needed vaccines through 2022. Israel is due to receive 10 million more doses of the AZ vaccine. “We don’t want (the vaccines) to get here and have to throw them in the trash,” said Israel’s pandemic coordinator Nachman Ash. Israel has re-opened after a successful vaccination campaign has inoculated 81% of the population.
With COVID-19 cases plummeting in the U.K., Roche is seeking a new location to conduct trials of its COVID-19 pill. The anti-viral therapy has drawn attention as an easier-to-administer alternative to Gilead’s antibody cocktail remdesivir.
Despite a decreased likelihood that the AstraZeneca COVID-19 vaccine will be used in the United States, AstraZeneca still plans to apply for emergency use authorization. A month ago, when AZ presented efficacy data for the vaccine in the U.S., the company said it would request authorization in the first half of April. The vaccine has been plagued by safety concerns and supply shortfalls. Story
UPDATED: Wednesday, April 21 at 3:20 p.m.
Following an inspection at Emergent BioSolutions' troubled Baltimore plant, the FDA cited the company for a raft of cleanliness and quality control issues, including its failure to properly investigate the ingredient mix-up that ruined up to 15 million doses of Johnson & Johnson’s shot. In a stunning finding, the FDA said Emergent can't be sure there weren't other instances of contamination. Emergent, for its part, said it's working to get the plant up to speed. Story
President Joe Biden celebrated reaching his goal of administering 200 million vaccine doses within his first 100 days in office while simultaneously urging adult Americans to get vaccinated if they haven’t already done so. Biden said the U.S. is entering a “new phase” in its vaccination effort as administration officials warn supply is beginning to outstrip demand in some places, NBC News reports.
A group of activist shareholders will push Pfizer and Johnson & Johnson to detail whether and how government funds for their COVID-19 vaccines will be taken into consideration when developing pricing and access strategies, according to proxy statements submitted ahead of annual shareholder meetings. Although the drugmakers have previously pushed back on the shareholder proposals, the Interfaith Center on Corporate Responsibility (ICCR) held out and successfully submitted the measures, which will go to a vote on Thursday. Story
UPDATED: Wednesday, April 21 at 9:40 a.m.
The European Union has decided not to exercise options for 300 million doses of COVID-19 vaccines from Johnson & Johnson and AstraZeneca, Reuters reports. The decision will mean Europe will rely more on mRNA shots for its immunization push moving forward.
Pfizer has identified the first confirmed instances of counterfeit versions of its vaccine, which were seized in Mexico and Poland, The Wall Street Journal reports. The company said it tested the shots and confirmed the vials contained fake vaccines. The vials in Mexico also had fraudulent labeling while the Polish counterfeits likely contained an anti-wrinkle treatment, the WSJ reports. Story
Congressional lawmakers are opening an investigation into Emergent BioSolutions, which was responsible for millions of ruined doses of Johnson & Johnson’s COVID-19 vaccine at its plant in Baltimore earlier this month. The investigation, led by the House Committee on Oversight and Reform, will try to determine whether Emergent “leveraged its relationship with a key Trump Administration official to profit from federal contracts despite a track record of raising prices and failing to meet contract requirements."
India’s Bharat Biotech said its COVID-19 vaccine, Covaxin, demonstrated 78% efficacy in a phase 3 interim analysis. The shot protected all recipients against severe disease and posted a 70% efficacy against asymptomatic COVID-19, suggesting the vaccine could decrease the virus' transmission in recipients.
Japan is in talks with Pfizer to secure 50 million more doses of its COVID-19 vaccine, which would provide the country with enough supply to immunize its population without using any doses it purchased from AstraZeneca, according to the Nikkei. The additional doses will be enough to immunize 110 million residents with vaccine supplies from Pfizer and Moderna, Bloomberg reports.
The Serum Institute of India will be able to raise its output of AstraZeneca’s vaccine to 100 million doses per month by July, up from the 60 to 70 million doses it’s making per month now, its chief executive Adar Poonawalla told CNBC-TV18. However, that’s later than a previous timeline that said the Serum Institute would reach that monthly mark by the end of May, Reuters reports.
UPDATED: Tuesday, April 20 at 4:15 p.m.
Johnson & Johnson said it will resume rolling out its single-dose COVID vaccine in Europe after the European Medicines Agency (EMA) said the shot’s risk-benefit profile remains favorable, Reuters reports. The company temporarily halted deliveries last week following reported cases of rare brain blood clots in six women who received the vaccine.
It’s going to be a big week for Johnson & Johnson’s vaccine, and the company is “cautiously hopeful that there is a very viable path forward” for the shot, CFO Joe Wolk told analysts on an earnings call. J&J’s chief scientist Paul Stoffels said if regulators provide guidelines on how to identify and treat cases of rare blood clots occurring in vaccine recipients, J&J believes it can “restore the confidence” in its vaccine. Story
Supply problems that have hindered AstraZeneca vaccine deliveries to COVAX, the global vaccine distribution effort looking to deploy doses in low-income countries, have been resolved, a UNICEF representative tells Reuters. The facility should receive 65 million doses by the end of May from manufactures outside of India, which placed a temporary hold on exports made by the Serum Institute of India.
Bharat Biotech announced plans to upgrade two plants to boost its production of its COVID-19 vaccine Covaxin to nearly 700 million doses a year, Mint reports. The lift comes after the Indian government awarded the drugmaker nearly $200 million to upgrade capacity amid a sharp rise in local coronavirus infections. Story
UPDATED: Tuesday, April 20 at 9:30 a.m.
The European Medicines Agency's safety committee identified a "possible link to very rare cases of unusual blood clots" after Johnson & Johnson's vaccine. The risk-benefit profile remains favorable, officials said. The shot can be used with a new warning on its product information.
Roche chairman Christoph Franz said he would be in favor of requiring COVID-19 vaccines once they’re available and have proven to be safe and effective, newspaper Handelszeitung reports, citing an interview. Franz acknowledged the idea may be controversial, but “a mandatory vaccination creates freedom in other areas” that have reverted to lockdowns to slow the virus’ spread. Roche told Reuters the comments reflected Franz’s “personal opinion.”
Spain will test the effects of mixing two different COVID-19 vaccines after the country decided to limit the use of AstraZeneca’s shot to people over 60, Reuters reports. The trial will involve a sample of 600 people of all ages across Spain to see if a dose of Pfizer’s vaccine can be given 28 days after someone’s first AstraZeneca shot. A similar study led by the Oxford Vaccine Group is underway in the U.K.
Johnson & Johnson is facing backlash for a media statement it issued earlier this month following reports of rare and severe blood clots among recipients of its vaccine, saying a study showed the same thing happened with "all Covid-19 vaccines.” The study’s lead author, however, told CNN that’s not what the study found, adding that she and her colleagues didn’t analyze for blood clots at all.
Johnson & Johnson said it's looking to conduct a local clinical trial in India for its vaccine as the country faces a surge in COVID-19 cases. The company told Reuters it requested the “bridging” safety and immunogenicity study to comply with India’s drug regulations.
UPDATED: Monday, April 19 at 3:13 p.m.
CVS and Walgreens are now stocking their virtual and in-store shelves nationwide with rapid COVID-19 tests that can be purchased without a prescription and used by anyone regardless of whether or not they are showing symptoms. The price tag for the kits—produced by LabCorp, Ellume and Abbott—range from as low as $24 to over $100. Story
A study of Russia’s Sputnik V vaccine between December and March involving 3.8 million people found the vaccine had a 97.6% efficacy, according to a statement from The Gamaleya National Research Center and the Russian Direct Investment Fund. Those findings are compared to a previous interim analysis involving roughly 20,000 people, published in The Lancet earlier this year, that found the shots were 91.6% effective against COVID-19. The latest findings will be published in a peer-reviewed medical journal in May, the vaccine’s developers said.
India is set to approve the Serum Institute of India’s 30 billion rupee ($400 million) grant request to help boost production of AstraZeneca’s COVID-19 vaccine, The Economic Times reports, citing a government source close to the talks. The funds will help the world’s biggest vaccine maker produce more than 100 million doses of the shot per month by the end of May, up from around 70 million doses per month, the publication reports. Story
The CEO of the Russian Direct Investment Fund, Kirill Dmitriev, said Europe should embrace Russia’s Sputnik V vaccine amid the region's turbulent immunization program, CNBC reports. Dmitriev warned against a “Pfizer monopoly” in Europe that could drive up prices for the shots. The RDIF funded the development of the Sputnik V vaccine.
Israel said it signed a deal to buy millions of doses of Pfizer and BioNTech’s vaccine through 2022, Reuters reports, citing a statement from Prime Minister Benjamin Netanyahu. The fresh vaccines will protect residents against emerging variants of the virus, Reuters reports.
UPDATED: Monday, April 19 at 9:25 a.m.
The European Union will tap 100 million more vaccine doses from Pfizer and BioNTech under a previous agreement, bringing the bloc's total supply of the two-dose mRNA vaccine to 600 million. All of those doses will be delivered this year, which should be enough to vaccinate two-thirds of the EU population, BioNTech’s chief commercial officer, Sean Marett, said.
The FDA has asked Emergent BioSolutions to stop making new drug material at its plant in Baltimore where millions of Johnson & Johnson vaccine doses were ruined, Reuters reports. Emergent told Reuters that the federal agency started its review of the facility last week and requested the halt pending its review. Emergent said it will quarantine existing material until the review is complete. Story
The FDA said it revoked its emergency use authorization for Eli Lilly’s monoclonal COVID-19 antibody bamlanivimab when administered by itself because the potential benefits of the solo antibody no longer outweigh the risks. The FDA noted that emerging variants of SARS-CoV-2 have shown to be resistant to the treatment. Lilly still supplies the drug mixed with etesevimab, and the combo holds up against the variants. Story
Infectious disease expert Anthony Fauci said he expects a decision on the hold of Johnson & Johnson’s vaccine to come by the end of this week. Appearing on Sunday talk shows, Fauci said he doubts the shot will be completely canceled, however, there will likely be additional restrictions or warnings that come with its use moving forward. Story
According to heart doctors and other medical experts, resuming the use of Johnson & Johnson’s vaccine will require clear recommendations for the medical community on how to treat patients that develop a rare but severe type of blood clot, Reuters reports. The shot’s resumption will also rely on federal health agencies to provide vaccine recipients with the clot’s telltale symptoms.
All U.S. states, Washington D.C. and Puerto Rico now offer COVID-19 vaccines to every adult, meeting President Joe Biden’s April 19 deadline, The New York Times reports. In the U.S., the CDC now reports that over half of all adults have been given at least one dose.
UPDATED: Friday, April 16 at 4:26 p.m.
The Biden administration detailed a nearly $2 billion plan to help tackle emerging variants of Sars-CoV-2, the coronavirus that causes COVID-19. More than half of the funding would go to the CDC and states to analyze positive test results through genomic sequencing. The remaining funding would help create a system for storing and sharing that sequencing data and establish partnerships among academic institutions and state health departments, The New York Times reports.
Moderna said it will cut vaccine deliveries to “a number of countries,” including the U.K. and Canada, because of a shortfall in its European supply chain. While the company didn’t specify how many doses would be cut and where, Canadian officials said Friday that the country's April shipments will contain 650,000 doses instead of an expected 1.2 million.
UPDATED: Friday, April 16 at 11:45 a.m.
Johnson & Johnson reportedly reached out to rival COVID-19 vaccine makers—including AstraZeneca, Moderna and Pfizer—last week, hoping to join forces to study cases of rare and severe blood clots cropping up in some vaccinated people, The Wall Street Journal reports. J&J reportedly wanted to form an effort to study the cases and allay fears among the public about the safety of the vaccine, but Moderna and Pfizer turned down the request. Story
A surplus of COVID-19 vaccines is starting to pile up in many states and cities across the U.S., a sign that supply could be starting to outweigh demand in some areas, according to a new Bloomberg analysis. While appointments can still be hard to come by, the analysis found that as many as one in three doses go unused in some states. Top U.S. health officials are beginning to rethink their strategy for distributing the doses based on population.
Although AstraZeneca has hit “bumps on the road" during its vaccine rollout, CEO Pascal Soriot said the company has still been able to deliver a large supply of doses in the first quarter and will continue to ramp up production. Speaking at a Gavi, the Vaccine Alliance event, Soriot said AstraZeneca has supplied 38 million doses to COVAX, the global vaccine distribution effort looking to deploy doses in low-income countries.
The Haffkine Institute has been given the nod from India’s drug regulator to begin manufacturing doses of Bharat Biotech's COVID-19 vaccine Covaxin, a promising bump in India’s vaccine production as it faces a surge in cases, the Hindustan Times reports. However, the Mumbai-based Haffkine said it will take at least one year for it to begin producing the doses.
After halting the use of AstraZeneca’s vaccine in its own rollout over safety concerns, Denmark is now looking at options for sharing its doses with other countries, the World Health Organization’s regional director for Europe, Hans Kluge, said.
UPDATED: Thursday, April 15 at 3:22 p.m.
Those who have been vaccinated against COVID-19 will "likely" need a third shot in 12 months, Pfizer CEO Albert Bourla told CNBC. He also anticipates people will need to be vaccinated annually. Johnson & Johnson CEO Alex Gorsky had said the same in February regarding the probability of annual vaccinations.
Intellectual property rules may need to be adjusted to improve worldwide access to COVID-19 vaccines, U.S. trade representative Katherine Tai said during a World Trade Organization conference. The statement comes amid debate between drugmakers and public health advocates. The WTO is weighing a proposal from more than 100 developing countries, including India and South Africa, that would temporarily suspend global IP rules to boost global vaccine production.
A poll conducted by Quinnipiac University reveals that 45% of Republicans do not plan to get vaccinated, which raises the question of whether the United States can achieve herd immunity. Another poll by Monmouth University shows that among Democrats 67% have received at least one vaccine dose, while just 36% of Republicans have received a shot.
With agreements in place for Johnson & Johnson to supply more than 1 billion COVID-19 vaccine doses around the world, its pause in the United States and Europe could have global implications.
The pause of the Johnson & Johnson COVID-19 vaccine in the United States and Europe is a big opportunity for mRNA vaccines from Moderna and Pfizer-BioNTech in the short and long term, according to Cantor Fitzgerald analyst Louise Chen. Story
Novartis will help manufacture Roche’s Actemra, a rheumatoid arthritis treatment which has been repurposed for COVID-19 patients. A Novartis plant in Singapore will perform the production after upgrades are made in the second quarter. It is the third such agreement for Novartis, which is also using its manufacturing capability to produce a COVID-19 vaccine for CureVac in Austria and the COVID-19 vaccine for BioNTech in Switzerland. Story
Moderna co-founder and MIT professor Robert Langer and Acuitas Therapeutics co-founder Pieter Cullis, whose firm played a major role in the development of the Pfizer-BioNTech COVID-19 vaccine, are not only major players in the coronavirus fight, they’re also trending on TikTok. The scientists are showing off their humorous side on the social media platform as they dance and discuss the vaccines they helped develop. Story
UPDATED: Thursday, April 15 at 10:08 a.m.
The CDC’s Advisory Committee for Immunization Practices (ACIP) decided to delay its decision on the use of Johnson & Johnson’s COVID-19 vaccine while it continues to assess the reported cases of a rare and severe type of blood clot. The panel plans to meet again within the next week to 10 days, keeping J&J’s shot on pause until then. Story
Merck will discontinue its development of MK-7110 for hospitalized COVID-19 patients, the biological immunomodulator Merck picked up when it acquired OncoImmune late last year. The drugmaker decided to concentrate its resources elsewhere after the FDA said Merck would need to provide additional data on MK-7110, which would delay its market access until the first half of 2022. Merck said it will continue advancing its oral antiviral drug molnupiravir in outpatients. Story
Moderna reportedly met with Nexus Pharmaceuticals on Tuesday to discuss manufacturing its vaccine at the company’s new plant in Wisconsin, which has the ability to process and fill 30 million doses per month, sources familiar with the discussions tell Reuters. It’s unclear if the meeting will result in a manufacturing deal, the sources said. Story
Denmark said it will stop using AstraZeneca’s COVID-19 vaccine altogether after the shot was linked to cases of rare but serious blood clots, becoming the first country globally to do so, Reuters reports. AstraZeneca said it respected Denmark’s decision and will continue to provide the country with more data to inform future decisions.
The Indian government said it plans to increase the production and supply of Gilead Sciences’ antiviral drug remdesivir. Manufacturers of the drug have agreed to reduce the price by the end of the week, the Hindustan Times reports. The government has approved seven additional manufacturing sites following a spike in demand.
Russia will begin shipping doses of its Sputnik V vaccine to India beginning in mid-May, and local production could begin as early as July, according to top officials from Dr. Reddy’s Laboratories. India became the 60th and most populated nation globally to authorize the Sputnik V vaccine earlier this week.
UPDATED: Wednesday, April 14 at 3:35 p.m.
A panel of CDC experts are reviewing the latest data for Johnson & Johnson's COVID-19 vaccine Wednesday afternoon and plan to issue updated recommendations about how to proceed. The panel is expected to finish its review at around 4:30 p.m. ET. Agenda
As Pfizer negotiates COVID-19 vaccine supply deals with Europe, Bulgarian Prime Minister Boyko Borissov said the new doses will come with a higher price, Reuters reports. Borissov said the new doses will cost €19.5, up from €12 originally, according to the news service.
A new study found that the AstraZeneca COVID-19 vaccine induced stronger T-cell responses in older adults than the Pfizer vaccine, Financial Times reports. It was the first head-to-head study between the shots.
UPDATED: Wednesday, April 14 at 10:05 a.m.
The European Commission reportedly won’t renew its contracts with Johnson & Johnson and AstraZeneca for their vaccines once they expire, Italian daily La Stampa reports, citing an official with the Italian health ministry. The report said the commission would rather focus on securing more doses that use mRNA technology, such as those from Pfizer and Moderna.
Moderna said its vaccine remained over 90% effective at protecting against COVID-19, and more than 95% effective against severe cases, up to six months after vaccination. The company said the high effectiveness kicked in two weeks after the second dose. Moderna cautioned that the results remain preliminary.
Moderna and Novavax shots will be added to a controversial U.K. study examining whether different vaccines could be used for first and second doses. The study, led by the Oxford Vaccine Group, will enroll people age 50 and older who’ve already had one dose. Researchers believe mixing the vaccines would allow for greater flexibility and a faster rollout.
Top U.S. health officials unanimously agreed during a meeting Monday evening to pause the use of Johnson & Johnson’s vaccine following reports from six women of rare blood clots, the Washington Post reports. The officials felt more cases could be going unreported, and they feared some people may receive the wrong diagnosis and treatment and could die as a result, according to the report.
Anthony Fauci, the nation's leading infectious disease expert, said he believes the hold on Johnson & Johnson’s vaccine will last for days or weeks, but not months. Fauci’s comment comes ahead of the CDC’s Advisory Committee for Immunization Practices (ACIP) emergency meeting scheduled for Wednesday afternoon to discuss how to proceed with administering the vaccine.
Novavax announced that Greg Covino will step down as the company’s chief financial officer due to personal reasons and will become an executive adviser. Chief Business Officer John Trizzino will serve as the vaccine developer’s top finance officer in the interim.
India is asking Pfizer, Moderna and Johnson & Johnson to seek authorization for their COVID-19 vaccines in the country after the government said it would fast track their applications. Pfizer, which withdrew its application for emergency authorization in February, told Reuters that it would work toward bringing its shot to India.
UPDATED: Tuesday, April 13 at 4:50 p.m.
Pfizer CEO Albert Bourla said the company will be able to supply the U.S. with its full 300 million doses two weeks ahead of schedule as production has accelerated. Pfizer can now supply the country with 220 million doses by the end of May, a 10% increase over previous forecasts, Bourla said.
The European Commission is asking Johnson & Johnson for more information regarding its “completely unexpected” decision to delay vaccine deliveries to the EU following reports of rare blood clots, an EU official told Reuters. The official said J&J confirmed at a meeting on Friday its intent to deliver 55 million doses to the EU by the end of June. For its part, J&J said it's reviewing the blood clot cases with European health authorities, Reuters reports.
More than 40 states have swiftly followed the call from federal health agencies to halt the use of Johnson & Johnson’s COVID-19 vaccine because of rare blood clots among six women who were vaccinated, The New York Times reports. CVS and Walgreens also said they would immediately stop administering J&J’s vaccine and reschedule appointments when able.
Rigel Pharmaceuticals announced positive results from its phase 2 trial evaluating hospitalized COVID-19 patients treated with fostamatinib, the company’s oral spleen tyrosine kinase. Out of 59 patients in the trial, three treated with fostamatinib developed severe adverse events by day 29 compared with six in the placebo group. None of the patients treated with fostamatinib died compared with three deaths reported in the placebo group, Rigel said. The company said it plans to share the results with the FDA.
A vast study to determine whether Moderna’s vaccine prevents the spread of COVID-19, and not just illness, is now underway and will eventually span 20 universities. The trial, backed by the National Institutes of Health, will follow 12,000 students over roughly five months to determine whether the shot protects them from becoming infected and transmitting the virus to close contacts.
UPDATED: Tuesday, April 13 at 10:05 a.m.
Federal health officials recommended an immediate pause in the use of Johnson & Johnson’s COVID-19 vaccine after six cases of rare blood clots were reported following vaccinations. The CDC’s Advisory Committee for Immunization Practices (ACIP) will hold an emergency meeting on Wednesday to “review these cases and assess their potential significance.” Nearly 7 million doses of J&J’s one-shot vaccine have been administered in the U.S. Story
Gilead Sciences said it will end its phase 3 trial studying its intravenous COVID-19 treatment remdesivir, marketed as Veklury, in high-risk non-hospitalized patients. Given the current landscape of the pandemic and challenges enrolling trial participants, the company said it doesn’t see the need for a multiple-day IV infusion in a healthcare setting. Story
Novavax pushed back its timeline for hitting a monthly production goal of 150 million COVID-19 doses to the third quarter of this year, a spokeswoman told Reuters, citing supply shortages. The Maryland-based vaccine developer previously aimed to reach full production by mid-year.
AstraZeneca said it had a positive meeting with the European Commission last week following reports that the company had yet to respond to a letter sent by the Commission in March regarding low vaccine supplies. An AstraZeneca spokesperson told Reuters that the company responded within the required time frame.
White House chief medical advisor Anthony Fauci told BBC Radio 4 that the U.S. likely won’t need AstraZeneca’s vaccine given the supply of doses the nation has already secured from other companies. However, the infectious disease expert added that his comments were not a “negative indictment” of AstraZeneca's shot.
PolyPeptide Group, which makes supplies for Novavax’s COVID-19 vaccine, said it plans to list a 40% stake on the Swiss stock exchange to help fund its growth. The company, controlled by Swedish billionaire Frederik Paulsen Jr., intends to list in the second quarter.
CDC Director Rochelle Walensky said Michigan Gov. Gretchen Whitmer should revert to lockdown measures to slow the virus’ transmission as the state battles the worst outbreak in the country. Despite pleas from state officials, Walensky said shipping more vaccine doses to Michigan wouldn’t be the best solution to curb its outbreak.
UPDATED: Monday, April 12 at 3:25 p.m.
An asthma drug with several suppliers, including AstraZeneca, could help reduce the recovery time for non-hospitalized COVID-19 patients by an average of three days, according to interim results from a UK clinical study led by Oxford University. Researchers studied the inhaled steroid, known as budesonide, helped people with severe symptoms such as cough and fever recover at home.
After the EMA announced a probable link between AstraZeneca’s COVID-19 vaccine and rare blood clots, countries that have authorized vaccinations are now faced with the tough decision regarding who should get the shots and who shouldn’t. European nations like Germany and France have limited Vaxzevria’s use to older residents over 60 and 55, respectively, while a vaccine advisory panel in the U.K. suggests offering a different vaccine to people under 30. The moves come despite the EMA’s word that the vaccine’s benefits still outweigh the risks.
Eli Lilly announced it will end its supply agreement with the U.S. for doses of its solo COVID-19 antibody treatment, bamlanivimab, after lab testing found it couldn’t hold up as well against emerging variants. The company will now shift its focus to its combo treatment, which includes bamlanivimab and etesevimab. The modified deal will cancel the 350,865 doses of bamlanivimab that were supposed to be delivered by the end of March. Story
UPDATED: Monday, April 12 at 10:39 a.m.
Roche and Regeneron announced positive results of a phase 3 trial of its combo of casirivimab and imdevimab against COVID-19 infection among household contacts of infected individuals. The subcutaneously administered cocktail reduced the risk of symptomatic infections by 81% in those who were uninfected when they entered the trial. Those who became infected cleared symptoms within a week on the average compared to three weeks for those on placebo. The study, conducted jointly with the NIH, included 1,505 who lived in the same house as an individual who tested positive within the prior four days. In addition, among recently infected asymptomatic patients, the treatment reduced the risk of progressing to symptomatic COVID-19 by 31%. Story
The pharma industry in virus-ravaged India is requesting emergency approval to override a patent by Gilead Sciences and produce COVID-19 treatment Remdesivir. Seven companies in the country currently produce the drug but it’s not enough to meet the domestic demand. India has prohibited export of the drug, just as it has done with COVID-19 vaccines manufactured there. The country is routinely reporting more than 100,000 new coronavirus cases daily. Story
In addition, India has approved Russia’s Sputnik V COVID-19 vaccine for emergency use. It’s the third COVID vaccine to receive a nod and the first that’s not produced domestically. Sputnik V already has deals in place with at least five vaccine manufacturers in India.
Rovi will produce bulk substance for Moderna’s COVID-19 vaccine, expanding an agreement between the companies. Rovi currently provides fill-finish for the vaccine, receiving substance from a Lonza plant in Switzerland. A new production line at Rovi’s plant in Granada, Spain, will make ingredients for up to 100 million vaccine doses a year.
Three vaccination centers in Colorado have stopped using the Johnson & Johnson COVID-19 vaccine, opting for shots by Pfizer and Moderna. The shift came after reports of side effects from J&J vaccine recipients including nausea, dizziness and fainting. Similar reports of side effects with the J&J vaccine in Atlanta, Georgia, led to the pause of a vaccination site. Officials said the side effects are consistent with those commonly experienced with vaccines and that the J&J shot is safe.
Due to the realtively low effectiveness of its COVID-19 vaccines, China may have to increase doses or use them in concert with another shot, said Gao Fu, the director of China’s CDC. In January, Brazil said that a phase 3 trial showed the efficacy rate of the jab from Sinovac was 50%. Sixty countries have approved shots from China, which will produce 3 billion doses this year.
Sanofi will spend $476 million over the next five years to create a vaccine production plant in Singapore that will employ 200 and primarily supply Asia. The facility will have more flexibility than Sanofi’s current sites, with the capability to produce three to four different vaccines simultaneously. Story
AstraZeneca’s phase 3 trial of diabetes drug Farxiga on patients hospitalized with COVID-19 who are at risk for serious complications failed to achieve statistical significance in measuring organ dysfunction and mortality. It was the first trial to evaluate a SGLT-2 inhibitor in at-risk COVID-19 patients.
UPDATED: Friday, April 9 at 2:44 p.m.
Pfizer and BioNTech have asked the United States to expand the emergency use approval of their COVID-19 vaccine to adolescents aged 12 to 15. Last month, in a clinical trial of that age group, the shot was shown to be safe and effective.
The European Union is pursuing a contract with Pfizer and BioNTech for the purchase of 1.8 billion doses of their COVID-19 vaccine to be delivered in 2022 and 2023, an EU source told Reuters. Half of the doses would be optional.
Germany is in talks with Russia for a supply deal of the Sputnik V COVID-19 vaccine, contingent upon the shot’s endorsement from the European Medicines Agency and the ability of it to be delivered within the next few months.
Eli Lilly and Incyte didn’t accomplish their primary objective in a phase 3 study of Olumiant plus standard of care for hospitalized COVID-19 patents. But Lilly is touting its rheumatoid arthritis treatment for reducing the risk of death by any cause by 38% in the trial. Researchers noted a benefit for patients on the medicine, regardless of how sick they were entering the treatment.
Pfizer CEO Albert Bourla told The Economist how the pharma’s quick and efficient response to the coronavirus pandemic has helped rebuild public confidence in the industry. He also spoke about how the pandemic has changed business in general and how the crisis will alter and improve operations in the future.
AstraZeneca’s COVID-19 vaccine has been in the crosshairs of regulators for blood clotting issues. But now the Johnson & Johnson shot is receiving similar scrutiny after four serious clotting cases came to light, including one in a clinical trial which was fatal. Story
The Emergent BioSolutions Baltimore plant responsible for the loss of 15 million doses of Johnson & Johnson COVID-19 vaccine faced FDA scrutiny last year, a new report shows. The April 2020 citation was for the lack of quality control procedures to prevent contamination or mix-ups. Story
HSBC and the Asian Development Bank will provide $300 million in loans to boost manufacturing capacity for COVID-19 vaccines in Asia. The initiative builds on a risk-sharing scheme the banks undertook in July of last year.
UPDATED: Friday, April 9 at 10:57 p.m.
Johnson & Johnson’s COVID-19 vaccine supply to the United States will drop significantly next week as the company deals with manufacturing problems. The company will supply just 700,000, according to the CDC. J&J refused to comment on the shortfall to The Wall Street Journal, but said it still expects to meet its pledge to provide 100 million doses to the U.S. by mid-year.
Following the lead of Germany, France has advised those under age 55 who have received one dose of the AstraZeneca COVID-19 vaccine to get a second shot with the Pfizer-BioNTech or Moderna vaccines. The recommendation comes even though this approach has not been tested. AZ’s shot is a traditional vaccine, while Pfizer’s and Moderna’s are mRNA vaccines. Some experts say the vaccines should be complementary since they target the same spike protein of the virus.
Because of supply concerns from the Serum Institute of India, the African Union has halted its pursuit of the AstraZeneca COVID-19 vaccine and will shift its attention to the Johnson & Johnson single-dose vaccine. African countries will still accept AZ shots through the World Health Organization’s COVAX effort. The AU said that the decision had nothing to do with blood clot concerns that have led several countries in Europe to limit use of the AZ shot. The Serum Institute has been forced to limit exports as India battles a coronavirus wave.
Biogen will pay $30 million to secure the rights to an experimental biosimilar version of Actemra, an anti-inflammatory drug with promise as a treatment for COVID-19. Actemra, which treats arthritis, generated $3.1 billion last year for Roche.
United States experts don’t believe the AstraZeneca COVID-19 vaccine will ever be used in the country despite the government’s $1.2 billion investment in the shot. With U.S. vaccine supplies plentiful and safety concerns for the AZ shot cropping up in Europe, an administration adviser told CNN that he hoped AstraZeneca would not apply for emergency use authorization.
With the United States sitting on a stockpile of more than 20 million doses of the AstraZeneca COVID-19 vaccine and the country not requiring them for domestic needs, many are urging the Biden administration to give them away to countries that face a dire need.
Depending on international drug shipments can be risky business, especially during a worldwide pandemic. Canada is among the countries feeling the pinch, and it has stepped up efforts to attract pharmaceutical companies. There's just one problem: Lots of other countries are doing the same, creating a bidding war. For example, to woo Sanofi to build a flu vaccine plant in Toronto–a deal that was announced last week–required a 50/50 investment split.
Johnson & Johnson will soon kick off clinical trials of its COVID-19 vaccine in India, which faces a vaccine shortage as it battles a coronavirus wave, reporting more than 100,000 new cases daily.
UPDATED: Thursday, April 8 at 2:25 p.m.
Among COVID-19 patients requiring supplemental oxygen but not ventilators, BeiGene's Brukinsa didn't top placebo at helping people survive longer before respiratory failure or paring down the number of days they spent on oxygen.
The Serum Institute of India has asked India's government for a $400 million boost to increase capacity to produce AstraZeneca COVID-19 vaccines. With India battling a severe coronavirus wave, most of the SII’s recent vaccine output has stayed at home. But that has prevented the SII from meeting its agreement to supply doses of the AZ vaccine to the worldwide COVAX relief effort. A $400 million investment would allow the SII to increase COVID vaccine capacity from 70 million to more than 100 million by the end of May. Story
The FDA has issued its first emergency use authorization for a home-collected COVID-19 antibody test. Developed by Symbiotica, the test detects antibodies in a dried blood sample taken at home and mailed to a lab. The test will allow healthcare professionals to identify those who have developed an adaptive immune response from a prior COVID-19 infection. Story
The United States no longer distributes Eli Lilly’s bamlanivimab because of doubts about its effectiveness against coronavirus variants. But the drug’s original developer, AbCellera, believes it can still be a valuable ingredient when combined with other treatments. Research supports this claim, especially when combating early-stage COVID and its variants. Story
UPDATED: Thursday, April 8 at 11:08 p.m.
An Operation Warp Speed report from last June warned of problems at the Emergent BioSolutions plant that was recently cited for the contamination of up to 15 million doses of the Johnson & Johnson COVID-19 vaccine. The factory lacked trained staff and had a record of quality control problems, officials found. The New York Times obtained the government report. Former Emergent officials suspect the J&J lot was tainted because an employee moved from AstraZeneca’s vaccine production area of the plant to J&J’s without showering or taking other precautions.
A study of 33 adult participants showed antibody persistence through six months after receiving a second dose of the Moderna COVID-19 vaccine. Antibody decay was consistent with convalescent COVID-19 patients eight months after the onset of symptoms. Moderna will continue to monitor responses beyond six months.
A phase 3 study released by Eli Lilly and Incyte evaluating baricitinib plus standard of care for hospitalized COVID-19 patents did not meet its primary endpoint. Patients receiving baricitinib were 2.7 percent less likely than those receiving standard of care to progress to ventilation or death.
After a European Medicines Agency finding of a possible link between the AstraZeneca COVID-19 vaccine and blood clots, Australia has discontinued its use among people younger than age 50. Front-line workers under age 50 will be prioritized for the Pfizer vaccine. The Philippines has taken the same action for those under age 60.
Eleven people had adverse reactions and two were hospitalized after receiving the Johnson & Johnson COVID-19 shot at a Dick’s Sporting Goods vaccination center in Colorado. The site was closed with hundreds waiting in line after 1,700 had received doses. Reactions included dizziness and nausea.
UPDATED: Wednesday, April 7 at 3:55 p.m.
The NIAID has launched a phase 2 trial to determine if people who are highly allergic or who have mast cell disorder are at increased risk for systemic allergic reactions to the Moderna and Pfizer COVID-19 vaccines. Systemic reactions occur in parts of the body aside from where the vaccine is administered. Most of the allergic reactions to COVID-19 vaccines have occurred in people with an allergy history. The study will enroll 3,400 adults.
The U.K. will offer people under age 30 an alternative to the troubled AstraZeneca vaccine. The decision came after the British drug regulator revealed that 79 AZ vaccine recipients in the country had suffered blood clots, with 19 of them fatal. The regulator said it wasn’t proof that the vaccine caused the clots but that the link was getting firmer. More than 20 million doses of the vaccine have been administered in the U.K.
The European Medicines Agency will investigate to determine if clinical trials of Russia's Sputnik V coronavirus vaccine meet ethical and scientific standards. Russia used military personnel and state employees in the trials, with some pressured to do so, according to Reuters. Approval of the jab in Europe could hinge on the findings.
The National Basketball Association has joined forces with Clear to use its Health Pass technology to keep the league’s arenas COVID free. Roughly a third of the NBA’s venues already use Clear’s digital tools to screen fans and employees. Health Pass technology allows users to add COVID test results and vaccine records. Story
UPDATED: Wednesday, April 7 at 10:35 a.m.
After an EMA official on Tuesday said there was a "clear" link between the AstraZeneca vaccine and rare blood clots, the European Medicines Agency released its own findings Wednesday. "Unusual blood clots with low blood platelets" should be listed as a very rare side effect on the vaccine's label, the agency said. Agency experts reviewed 62 cases cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis, including 18 deaths, in people following vaccination. The vaccine has been given to around 25 million people in Europe so far, and EMA concluded that the shot's overall benefits outweigh risks. Story
Emer Cooke, EMA's Exec. Director: “It is important that both vaccinated people and #healthcareprofessionals are aware of the signs and symptoms of these unusual blood clotting disorders and can spot them quickly to minimise the risk.”
— EU Medicines Agency (@EMA_News) April 7, 2021
Contracts signed between coronavirus vaccine manufacturers and the Trump administration prohibit the United States from sharing its surplus doses around the world, Vanity Fair reports. The provision has potential to be a PR nightmare for the U.S., which soon will have an enormous surplus while other countries face an urgent need for vaccines. The sharing ban, designed to ensure that manufacturers retain liability protection, is hindering efforts by the Biden administration to make America the world’s major supplier of affordable, high-quality vaccines.
The Emergent BioSolutions plant in Baltimore, which was cited for a mix-up that resulted in the loss of up to 15 million doses of Johnson & Johnson's COVID-19 vaccine, has produced 150 million vaccine doses. The catch? None have been distributed because regulators have not certified the factory. In a new report, The New York Times details the plant’s history of errors and compliance problems. Emergent received $163 million from the government to prepare it for high-volume production but the site was ill-equipped to take on the task, according to the report. In addition to the recent error with J&J vaccines, Emergent discarded up to 15 million doses of AstraZeneca's coronavirus vaccine between October and January because of contamination or suspected contamination, according to the story.
AstraZeneca agreed to shift COVID-19 vaccine production out of Emergent’s Baltimore Bayview plant, according to Biden administration adviser Andy Slavitt. The move prevents the kind of cross-contamination which resulted in the loss of up to 15 million doses of Johnson & Johnson’s COVID vaccine. J&J has taken over COVID vaccine production at the plant. Slavitt said the decision “says absolutely nothing about our belief” whether the AZ vaccine will be authorized in the U.S.
In Beijing, those who are vaccinated qualify for buy-one-get-one ice cream cones. This is just one of a variety of methods–some tantalizing, some threatening–that China is using to compel people to get their coronavirus shots. The tactics are working. This month vaccinations are averaging 4.8 million per day after averaging roughly 1 million daily last month.
Serum Institute of India CEO Adar Poonawalla said that exports of COVID-19 vaccines could resume by June if the country’s coronavirus situation improves. By halting exports last month, world relief effort COVAX has experienced a delay in delivery of up to 90 million vaccine doses.
A preclinical study shows that Ampio’s Ampion, which is used to treat a variety of inflammatory conditions, inhibits a key inflammatory pathway in both COVID-19 and lupus nephritis.
UPDATED: Tuesday, April 6 at 2:45 p.m.
The European Medicines Agency will hold a press conference on Wednesday or Thursday to detail its review of blood clotting cases in AstraZeneca COVID-19 vaccine recipients. The EMA’s top vaccine specialist said this week that a link has been established between the clotting events and the shot, but he also said the benefits of the vaccine far outweigh the risks.
A trial of the AstraZeneca COVID vaccine in children has been paused while the EMA investigates the link between the shot and rare blood clots.
R&D budgets soared in 2020 as pharmaceutical companies reacted to the coronavirus pandemic. Over the previous five years, the top 10 companies combined to spend roughly $70 billion, but last year that number swelled to $96 billion. Roche remained the top R&D spender last year, with Merck close behind. Here’s a look at how the top 10 stacked up and how they spent their R&D funds. Story
Teva Canada has launched an effort to relieve caregiver stress with a raft of new resources and programs to support mental health. Virtual life coaching sessions and free access to a caregiver support app are among the new features designed to combat the problem, which has grown during the pandemic. Story
Backed by a $53.7 million deal with the U.S. government, Ortho Clinical Diagnostics will bump up production of its antigen and antibody COVID-19 tests more than threefold. Through April 2022, Ortho plans to produce 6.7 million COVID tests each month compared with its current rate of 1.8 million. Story
UPDATED: Tuesday, April 6 at 10:58 a.m.
Novavax announced crossover arms for three clinical trials of its COVID-19 vaccine. Crossover will make sure to get active vaccines to participants in a phase 2b trial in South Africa, a phase 3 trial in the U.K. and a phase 3 trial in the U.S. and Mexico. Participants across all three trials will remain blinded to their courses of treatment to preserve the ability to assess efficacy. Later in the second quarter, Novavax expects to initiate pediatric and adolescent arms of the trials. Story
Catalent said it will use a new high-speed vial-filling line at its plant in Bloomington, Indiana, to manufacture Moderna’s COVID-19 vaccine. The line will be dedicated to Moderna’s use through June 2023. In September of last year, Catalent announced a $50 million investment into the new line. Last week, Moderna announced that it had reached its milestone of 100 million vaccine doses produced by the end of March.
The European Medicines Agency’s head of vaccines, Marco Cavaleri, said there is a link between the AstraZeneca coronavirus vaccine and blood clots, but that the benefits of the shot still outweigh its risks. In addition, according to reports, the U.K. is considering restricting use of the AZ vaccine in younger people. But the Medicines and Healthcare Products Regulatory Agency said no decision has been made. Story
The European Union has blocked shipments of 3.1 million doses of the AstraZeneca COVID-19 vaccine bound for Australia, a source told Reuters. Vaccinations in Australia are 83% behind schedule, lagging far behind those in the U.S. and U.K.
Walgreens will change its schedule for administering the Pfizer COVID-19 two-shot vaccine, delivering them the recommended three weeks apart instead of four. Separating the shots by four weeks had eased scheduling, the U.S. pharmacy claimed. The company all along has scheduled the Moderna vaccine the recommended four weeks apart. The CDC recommends a three-week gap for the Pfizer shot but also says it’s acceptable to separate doses by six weeks.
UPDATED: Monday, April 5 at 3:58 p.m.
Panacea Biotech is the latest CDMO in India to agree to produce Russia’s Sputnik V coronavirus vaccine, signing up to produce 100 million shots annually. Other companies from India that have made deals to produce the Sputnik V shot include Virchow Biotech, Stelis, Gland and Hetero.
The U.K. will make rapid, routine coronavirus testing free and available to everyone as part of a plan to lift lockdowns by the end of June. Twice-a-week testing will begin on April 9 with results expected at home within 30 minutes. The country also is considering implementing COVID-19 passports as a requirement to enter public gatherings such as concerts and sports events. Story
An attempt by CSL Behring and Takeda to develop a plasma-derived COVID-19 treatment has failed to meet endpoints in a phase 3 clinical trial. Story
The Biden administration has ordered Johnson & Johnson to take control of an Emergent BioSolutions plant in Baltimore where human error resulted in the loss of up to 15 million doses of coronavirus vaccines. That mistake and revelations that the plant had a history of compliance problems forced the government-imposed takeover. Story
As a result of the J&J takeover of the Emergent plant in Baltimore, AstraZeneca will have to find a new manufacturing partner for its coronavirus vaccine in America. The U.S. will assist in the effort as AZ faces yet another stumbling block in its efforts to deliver on supply promises. Story
A research team led by the University of Pennsylvania has identified three FDA-approved drugs that have potential to be effective against COVID-19 because they inhibit the virus in respiratory cells. Pfizer’s lung cancer drug Vizimpro, Hillstream’s antibiotic salinomycin and Novartis’ Sandimmune, which prevents rejection in organ transplant patients, are the drugs that have shown potential. The three emerged from a total of 3,059 compounds that were tested in kidney cells from monkeys and liver cells from humans. Story
Moderna’s rapid development of a coronavirus vaccine brought sudden visibility to the company and with it came security concerns. In its annual proxy filing, Moderna reported that it spent more than $1 million to protect CEO Stéphane Bancel. Story
UPDATED: Monday, April 5 at 11:38 a.m.
In response to Israel failing to pay for 2.5 million vaccine doses, Pfizer has halted shipment of 700,000 doses to the country. Israel’s vaccination campaign sprinted ahead of other countries because it was willing to pay a higher price.
One dose of the Pfizer vaccine significantly reduced coronavirus cases in nursing homes according to a real-world study by Yale and the CDC. The research was deemed crucial because phase 3 trials have largely been conducted in populations that do not replicate those who live in nursing homes. The research, done at two Connecticut nursing homes during outbreaks, found that one dose of the vaccine provided similar protection to that experienced by young people. The study will continue to determine efficacy rates of those fully vaccinated with two doses.
Production of the Pfizer-BioNTech COVID-19 vaccine will begin this week in France, at a factory in Normandy, kicking off a flood of new vaccine production in the country. Later this spring, first-time manufacture of the Johnson & Johnson and CureVac shots will begin. Moderna production is already underway in the country. Overall, seven facilities in France will contribute to an expected output of 250 million vaccine doses this year.
Cadila Healthcare is seeking approval in India for a hepatitis C drug as a COVID-19 treatment after promising results of a late-stage trial. Those administered the drug tested negative for the virus by day seven 91% percent of the time, compared with 79% who were given the standard of care drug in a phase 3 trial.
Johnson & Johnson’s COVID-19 vaccine is the vaccine of choice to help protect the homeless, The Wall Street Journal reports. The one-shot vaccine is better suited for an often-transient population that has grown during the pandemic, advocates say.
AstraZeneca COVID-19 vaccines from the COVAX relief effort will be delayed to the Philippines because of a supply shortage. A WHO representative also has informed the country that when the shipment eventually arrives, it will probably be reduced from the expected 920,000 doses.
UPDATED: Friday, April 2 at 10:22 a.m.
The United States' top infectious disease expert, Dr. Anthony Fauci, said that the nation may not need the AstraZeneca COVID-19 vaccine even if it receives FDA authorization. Fauci noted that contracts are already in place with other companies to vaccinate the population and to possibly provide booster shots in the fall.
The U.K. has identified 30 cases of blood clots after use of the AstraZeneca vaccine compared to none for the shot made by Pfizer and BioNTech. At the same time, British regulators said they believe the benefits of the AZ vaccine far outweigh the risks. In the U.K., 18.1 million doses of the AZ vaccine have been administered.
The FDA will allow the Moderna COVID-19 vaccine to be stored at room temperature for 24 hours before it is administered as opposed to the previous guidance of 12 hours. In addition, a punctured vial is available for use for 12 hours versus the current six hours. The FDA also will allow a new vial size of 15 doses.
Despite reports to the contrary, India says it has not restricted export of COVID vaccines. The Ministry of External Affairs claims the country has sent 64 million vaccine doses to more than 80 countries. India has exported 35.7 million doses on a commercial basis, 18.2 million doses to the worldwide COVAX relief effort and 10.4 million by way of grants.
Sinovac Biotech said it has completed a third production line for its COVID-19 vaccine and now is capable of supplying 2 billion doses per year. The Chinese company says it has delivered more than 200 million doses to more than 20 countries. The vaccine has received approval in more than 30 countries. Story
Johnson & Johnson has expanded an ongoing vaccine trial to include adolescents ages 12 to 17. J&J is starting with those aged 16 to 17 in Spain and the U.K. Enrollment will continue in the United States, Netherlands, Canada, Brazil and Argentina. Earlier this week, Pfizer and BioNTech reported successful results of a trial of their COVID vaccine on adolescents aged 12 to 15. Story
UPDATED: Thursday, April 1 at 3:57 p.m.
Workers at an Emergent BioSolutions’ plant in Baltimore mixed up ingredients in manufacturing the bulk substance for the Johnson & Johnson COVID-19 vaccine, resulting in the loss of a batch of 15 million doses. None of the batch was distributed and Emergent reported the error. The facility has yet to be approved for vaccine production. Johnson & Johnson and the FDA are investigating. Story
The Associated Press reveals that Emergent’s Baltimore plants have been flagged by the FDA for several quality control issues since 2017. Careless handling of rejected materials, failure to follow procedures to prevent contamination, data integrity concerns and a policy of not conducting routine compliance audits were among the items the FDA cited, according to the report.
The U.S. government has no intellectual property claim to Gilead’s remdesivir, according to a Government Accountability Office report. The antiviral drug, whose development began in 2009, quickly found its place as a COVID-19 treatment, gaining FDA approval in October of last year. Since the pandemic began, advocacy groups have urged the government to enforce patents against companies that have received government support, but GAO found that Gilead has sole rights to the med. Story
The FDA is speeding to market a variety of kits and instruments that can be used to administer routine tests in homes and businesses. After large portions of populations have been vaccinated, these tools will be a vital next step in building public confidence as people return to schools, offices, communities and public venues. Story
Using the COVID Symptom Study smartphone app, a self-reporting platform developed a year ago, a research team has discovered an algorithm that can predict at a 70% accuracy rate who is susceptible to long COVID syndrome. The model was built from a pool of 4,000 people who began using the app before showing symptoms and then received a positive COVID diagnosis. Researchers found that women, the elderly and those with at least five early symptoms are most likely to develop long-term effects. Story
UPDATED: Thursday, April 1 at 11:19 a.m.
The Pfizer-BioNTech COVID-19 vaccine is highly effective for up to six months and is capable of tackling an aggressive variant first identified in South Africa. With the new data, Pfizer is eying a full FDA approval for the shot, which won an emergency authorization in December. Story
A Merck manufacturing facility in Durham, North Carolina, faces serious allegations from a former FDA inspector-turned-whistleblower. The whistleblower claims Merck destroyed evidence of possible violations prior to an inspection he conducted in 2018. He also condemns the FDA for failing to act. The plant has been tapped in the COVID-19 vaccine production push. Story
President Joe Biden is seeking help from groups as disparate as the NAACP and NASCAR to reach people who are most resistant to coronavirus vaccines. Vice president Kamala Harris held an online event on Wednesday urging churches, native tribal leaders, civil rights activists and sports leagues to assist in the vaccination campaign.
UPDATED: Wednesday, March 31 at 3:45 p.m.
Pfizer and BioNTech plan to test a freeze-dried version of their COVID-19 vaccine, which if proven safe could ease delivery of the shot to rural areas and low-income countries. A powdered formulation of the vaccine would allow transportation and storage at normal temperatures instead of the ultracold storage it now needs. If successful, the new form of the vaccine could be ready early next year, Pfizer told investors on an earning call last month.
France will lock down for four weeks, closing schools and businesses as it deals with a coronavirus wave. “We did everything we could to make these decisions as late as possible, until they became strictly necessary, which is now,” said president Emmanuel Macron. The policy is a reversal for Macron, who previously allowed restrictions to be implemented by local authorities. With the move, France follows Germany and Italy which have stepped up lockdowns over the last week. Story
More than 100 fully vaccinated people in Washington state have tested positive for the coronavirus, most with mild symptoms. The breakthrough cases, which are not uncommon with vaccines, account for less than .01% of those who have been inoculated. The state will investigate further to determine if those infected have contracted coronavirus variants.
Some Asian countries, which were counting on COVID-19 vaccines from the COVAX global relief effort, are exploring other options. COVAX’s primary supply source is India, but that country has restricted vaccine exports as it battles a severe wave of infections. Russia and China are beginning to answer the calls of needy nations.
Pharma’s rapid response to the coronavirus pandemic has given the industry a much-needed public relations boost. But the trend could be short-lived, according to an opinion piece on Bloomberg. Lionel Laurent argues that companies guarding intellectual property rights and exacerbating the gulf between rich and poor nations are flirting with a PR nightmare.
UPDATED: Wednesday, March 31 at 11:18 a.m.
Amid a whirlwind of safety concerns over its COVID-19 vaccine, AstraZeneca named its vaccine Vaxzevria. It was previously known as the AstraZeneca Covid-19 Vaccine. While the shot remains unaltered, the packaging and labeling will change. Covishield, the version of the vaccine created along with the Serum Institute of India, will retain its name. Story
A phase 3 trial of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12 to 15 showed 100% efficacy and robust antibody responses, exceeding those in an earlier test of participants aged 16 to 25. Pfizer CEO Albert Bourla said he hopes emergency use authorization will be expanded to this age group and allow for vaccinations to begin before the school year. Last week Pfizer and BioNTech launched studies of the vaccine in children aged 6 months to 11 years.
T cells may hold the key to defending against coronavirus variants, according to a small lab study by the National Institute of Allergy and Infectious Diseases. An analysis of the blood of 30 participants who had recovered from COVID-19 showed that T-cell responses remained intact and could recognize virtually all mutations in the variants studied. Larger studies are needed to confirm the findings.
Following the lead of Berlin, several German regions have suspended use of the AstraZeneca COVID-19 vaccine for people under age 60. The move is in response to continued reports of cerebral blood clots, with 31 so far being reported in the country. Nine in Germany have died after taking the vaccine, all of them women.
UPDATED: Tuesday, March 30 at 3:40 p.m.
Pfizer will step up delivery of its COVID-19 vaccine to Canada, according to prime minister Justin Trudeau. The news comes a day after the country’s drug watchdog urged provinces to halt vaccinations with the AstraZeneca shot for those under age 55. Pfizer will send 5 million more doses than previously scheduled by the end of June. The company was set to deliver 1 million doses weekly in May and June, but it now will provide 2 million doses weekly in June.
Drugmakers have inked unprecedented collaborations in response to the pandemic. Many attorneys interviewed by Bloomberg Law, however, don’t expect the trend to continue into the future, citing intellectual property and other legal and logistical issues.
Riding high on Moderna's COVID-19 vaccine launch, CEO Stephane Bancel raked in $12.85 million in compensation last year, up from $8.9 million in 2019, according to a proxy filing. In addition to his salary of $950,000, Bancel received a $1.9 million bonus and stock options worth $9 million. In 2018, Bancel’s package was a hefty $58.6 million, thanks to the company’s $604 million public offering. Story
Johnson & Johnson’s manufacturing partner for its COVID-19 vaccine, Emergent BioSolutions, is still awaiting regulatory clearance. The holdup has the potential to hinder supply, but there are indications that the approval is imminent. Story
In the coronavirus pandemic age, social media platforms such as TikTok are creating brand recognition and more broadly, new awareness of the pharmaceutical industry, especially in younger people. Some believe this is a turning point for the industry. Proactive companies may be in position to optimize it. Story
IBM and New York state have created a digit passport system which will allow businesses and venues to verify a person’s vaccination status before allowing them entry. Users link their vaccination records to the Excelsior Pass app, which displays a QR code that can be scanned. Story
UPDATED: Tuesday, March 30 at 10:51 a.m.
After setting what seemed an ambitious goal to deliver 2 billion doses of their COVID-19 vaccine this year, Pfizer and BioNTech are bumping the projection further. On Tuesday, BioNTech said the new target was 2.5 billion doses. The recent approval of its manufacturing facility in Marburg, Germany, and regulatory approvals for the six-dose vial have influenced the change. Story
Johnson & Johnson will begin supplying its COVID-19 vaccine to the European Union on April 19, the company announced. The EU has ordered 200 million doses of the single-shot vaccine, with an option for 200 million more.
The Pfizer-BioNTech and Moderna COVID-19 vaccines were highly effective in preventing infections among healthcare and other essential workers in a real-world study released by the CDC on Monday. Two weeks after receiving a second dose, the risk of infection was reduced by greater than 90%. Two weeks after receiving one dose, risk was reduced by 80%. The study included 3,950 participants in six states. Story
Celonic will manufacture at least 100 million doses of CureVac’s mRNA COVID-19 vaccine at its plant in Heidelberg, Germany, providing bulk substance for 50 million doses by the end of this year. The vaccine has yet to gain regulatory approval, but CureVac said it has secured manufacturing resources in Europe capable of producing 300 million vaccine doses by the end of this year.
Berlin has suspended use of the AstraZeneca coronavirus vaccine among people under age 60 because of blood clots. The European Medicines Agency advised that the vaccine was safe on March 18, triggering a wave of countries reinstating its use after temporarily suspending it. Germany’s medical regulator has said 31 cases of cerebral venous thrombosis have been reported by AZ vaccine recipients, with nine deaths. All but two of the cases were among women aged 20 to 63.
Manitoba and Quebec provinces have also stopped administering the AstraZeneca COVID-19 vaccine to people under age 55 after Canada’s National Advisory Committee on Immunization and Health recommended halting its use because of reports of blood clots in Europe. Earlier this month, NACI urged that the AZ shot should not be provided to those 65 and older, then later reversed the guidance. Canada has ordered 22 million doses of the AZ vaccine and was set to receive an additional 1.5 million from the United States’ surplus on Tuesday.
Meanwhile, Mexico has received its first shipment from the United States’ surplus stock of AstraZeneca COVID-19 vaccines. The 1.5 million doses are part of a 2.7-million deal struck between the countries. Mexico has now received 12.3 million vaccine doses.
Michigan will inform recipients of the Johnson & Johnson COVID-19 vaccine that it was developed using a stem cell line from an aborted fetus. The new law is part of a broader bill concerning the distribution of federal coronavirus funds to the state. It has not been decided how the notification will be provided to J&J vaccine recipients. Michigan Right to Life president Barbara Listing applauded the change, saying the way the vaccine was developed was an “ethical concern.”
Far-left protesters in Argentina gathered at mAbxience’s vaccine plant in Buenos Aires, criticizing the slow rollout of vaccinations and preferential treatment. Protesters are urging the state to take control of the plant, which is producing vaccines for AstraZeneca. Another manufacturer in the AZ production line, Mexican lab Liomont, has been blamed for the supply problems.
With CDC warnings of “impending doom” of a potential fourth surge of the coronavirus pandemic, President Joe Biden called on local leaders to reinstate mask mandates. The warning came from CDC director Rochelle Walensky in an emotional announcement in which she said, “I’m scared.” New COVID cases in the U.S. are at 63,000 daily, an increase of 16% from two weeks earlier. Experts say the U.S. is in a race between the vaccination campaign and the spread of potentially more transmissible and lethal coronavirus variants.
UPDATED: Monday, March 29 at 3:30 p.m.
NeuroRx's drug Zyesami posted positive data in a phase 2/3 study in patients with critical COVID-19 and respiratory failure, the company said. Pitted against placebo, the drug showed benefits in recovery from respiratory failure. NeuroRx plans to submit the data to the FDA.
GlaxoSmithKline and Novavax have inked the pharma industry's latest COVID-19 vaccine manufacturing partnership, with the British drugmaker signing up to help produce 60 million doses for use in the U.K.
As the U.S. races to vaccinate its population and other countries wait for doses, President Joe Biden is facing calls to break pharmaceutical patents to increase access elsewhere. But one influential expert argues the measure wouldn't boost access. Meanwhile, other options are on the table, too. Story
Biden is planning to announce Monday that 90% of American adults will be eligible for COVID-19 vaccines in three weeks, CNN reports. The number of pharmacies giving shots is set to double.
UPDATED: Monday, March 29 at 10:38 a.m.
The European Medicines Agency has taken several measures which should speed COVID-19 vaccination efforts in Europe. In the Netherlands, the EMA has approved a Helix plant in Leiden which will produce the active substance for AstraZeneca’s vaccine. In Germany, the EMA has signed off on a facility in Marburg which will manufacture the substance and finished product for the Pfizer-BioNTech vaccine. The EMA also will allow the Pfizer-BioNTech vaccine to be stored at regular pharmaceutical refrigerator temperatures for up to two weeks. In addition, the EMA has approved new manufacturing lines at the Lonza plant in Visp, Switzerland, and has greenlighted other manufacturing processes which will bolster production capacity.
A phase 3 trial of Humanigen’s lenzilumab in hospitalized COVID-19 patients has met its primary endpoint, which may clear the way for emergency approval from the FDA. The drug counters life-threatening complications that arise when the immune system reacts strongly to the virus. Shares of Humanigen jumped 64% in premarket trading, continuing a trend over the last year that has seen shares rise from less than $2 to more than $20. Story
Eli Lilly, Vir Biotechnology and GlaxoSmithKline announced a phase 2 trial of their antibody cocktail showed a 70% reduction in high viral load at day seven for low-risk adult patients with mild to moderate COVID-19, meeting the study's primary endpoint.
Group 42 of the United Arab Emirates will produce the Sinopharm COVID-19 vaccine. Group 42’s new fill-finish plant in Abu Dhabi will have the capacity to provide 200 million doses per year. Interim production of the vaccine is already underway in the emirate of Ras al-Khaimah per a joint venture between Sinopharm, Group 42 and Gulf Pharmaceutical Industries. That plant can produce 2 million doses monthly. The UAE approved the vaccine in December.
A Pfizer executive, who doubles as the chairman of the NVFG, the Netherlands association for pharmaceutical industry, said that pharmaceutical companies should have representation on the country’s Outbreak Management Team, which advises the Dutch government on how to deal with epidemics. While acknowledging that the pharma industry has financial interests, Marc Kaptein told the NL Times that by not including its input, the country suffered “a delay in the vaccination campaign at least."
Johnson & Johnson will provide 220 million doses of its single-shot COVID-19 vaccine to the African Vaccine Acquisition Trust starting in the third quarter of this year. The agreement includes an option for 180 million additional doses to be delivered by the end of 2022. Availability of the shot is contingent upon its approval by individual countries. J&J has nine manufacturing and supply partners across four continents including Aspen Pharmacare in South Africa, which will support vaccine shipments to the 55 members of the African Union. Story
The European Medicines Agency has issued a positive opinion for Celltrion’s COVID-19 antibody treatment candidate, regdanvimab. The EMA’s Committee for Medicinal Products for Human Use recommends the drug for patients at a high risk for severe COVID-19. The EMA has issued a rolling review, which could speed its authorization. The Korea Disease Control and Prevention Agency has already confirmed the effectiveness of the drug against COVID-19 variants.
The initial investigation of a packaging flaw which resulted in temporary suspension of the Pfizer-BioNTech COVID-19 vaccine in two districts in China has found no safety concerns. Loose vial caps and stained bottles forced the halt of the shot’s distribution in Hong Kong and Macao. The investigation has found no evidence of leakage. BioNTech and Fosun, which distribute the vaccine in China, have not turned up any systemic factors which could have caused the packaging errors. The investigation should be concluded within a week.
UPDATED: Friday, March 26 at 3:05 p.m.
So far in its U.S. rollout, Johnson & Johnson's vaccine has only been administered to 2.8 million people, according to CDC data. Distribution of the single-dose shot is set to expand next week, with 11 million doses on the way, Reuters reports.
After posting positive data in phase 3, GlaxoSmithKline and Vir Biotechnology are submitting their dual-acting antibody to the FDA. Story
Pfizer has started testing its COVID-19 vaccine in children just as new data support using mRNA vaccines in pregnant women. Vaccinating children is seen as a key step in reaching herd immunity to beat back the pandemic. Story
UPDATED: Friday, March 26 at 10:42 a.m.
Novavax is struggling to secure raw materials for its COVID-19 vaccine and that shortfall has led to a delay in signing a supply contract with the European Union, Reuters reported. The company had planned to provide 100 million vaccine doses to the EU, with an option for another 100 million. One of Novavax’s primary manufacturers, the Serum Institute of India, warned this month that a temporary U.S. ban on exports of raw materials could affect its vaccine production.
Moderna delayed shipment of 590,400 doses of its COVID-19 vaccine to Canada, explaining that it faced a “backlog in its quality assurance process.” The company said it was a minor holdup that shouldn’t affect next week’s scheduled delivery of 855,600 doses to the country, which is bracing for a third coronavirus wave as the British variant has broken out in some hot spots.
Thermo Fisher Scientific said Thursday it would chip in on production of Pfizer and BioNTech’s COVID-19 vaccine in Italy, Reuters reports. In an emailed statement to Reuters, the company said it was working as part of Pfizer and BioNTech’s global manufacturing network and would assist with shots pegged to roll out in “several markets.” The company said it would provide fill-finish work at its facility in Monza, outside Milan, this year.
India’s own battle against the coronavirus is having a ripple effect, hindering vaccination efforts in many countries around the world. The Serum Institute of India, the most prolific producer of vaccines on the planet, is cranking out 2.4 million COVID-19 shots per day but most of those are held back for domestic use to try to stunt a wave of new infections that's surged to 50,000 cases per day. As a result, many of the 70 countries that received shipments from the Serum Institute over the first 10 weeks of the year have seen the supply dry up.
President Joe Biden has not only adjusted his vaccination goal, he’s doubled it, hoping to get 200 million vaccine doses into the arms of Americans by his 100th day in office, April 20. The U.S. reached Biden’s previous goal—100 million doses—on March 18, which was his 58th day in office. The U.S. has administered 133 million doses so far and is averaging 2.5 million shots daily.
SGD Pharma of France, a supplier of glass vials, is up for sale by its owner, China Jianyin Investment. CJI is seeking more than $1.2 billion, a source told Reuters. SGD Pharma has five facilities in Europe and Asia, which produce more than 8 million bottles and vials daily. To attract COVID-19 business in 2020, the company advertised a daily manufacturing output of more than 400,000 vials from its location in Normandy, France.
Courtesy of embattled New York Gov. Andrew Cuomo, Regeneron co-founder and president George Yancopoulos and a member of his family got preferential treatment in securing COVID-19 tests last March, when testing resources were scarce. The tests were performed after another member of the Yancopoulos family was infected by the virus. Story
Oxford is launching a phase 1 trial of a nasal spray COVID-19 vaccine, registering 30 volunteers aged 18-40. The spray will use the same ChAdOx1 nCoV-19 compound as the AstraZeenca shot. Because inhaled vaccines are more appealing to some than injections, finding an effective nasal spray would allow more to be vaccinated. Nasal vaccines are in use in U.K. schools to defend against the flu. Story
Russia’s Sputnik V—the only vaccine with its own Facebook page, YouTube channel and Twitter account—is using all of these social media platforms to bolster its reputation. Fortune takes a look at the campaign.
UPDATED: Thursday, March 25 at 3:28 p.m.
Pfizer has begun testing its COVID-19 vaccine in children aged 6 months to 11 years. The shot is currently authorized for people 16 and older. The company has already initiated testing the vaccine in those aged 12 to 15. Children are at lower risk for contracting the disease and generally have milder symptoms. But because they can spread the virus, vaccinating children is a key stop to achieving herd immunity.
COVID-19 vaccines from Pfizer and Moderna are effective in pregnant and lactating women, according to a study published in the American Journal of Obstetrics and Gynecology. In the study of 84 women in Massachusetts, those who were vaccinated had “strikingly” higher antibody levels than pregnant women who had recovered from COVID-19 infections. The women also passed antibodies to their newborns and to lactating babies. The study is important because infected pregnant women have been found to have a higher risk for developing severe cases and for giving birth preterm.
Researchers at the University of Illinois Chicago have identified a potent new compound that can block viral replication in human cells and may eventually provide a new COVID-19 treatment. The discovery was made with the help of Kiira Ratia, who applied her study of SARS-CoV-1 to the current virus. The UIC researchers believe their lab-developed protease inhibitor XR8-24 is superior to FDA-approved remdesivir.
Denmark will extend its suspension of the AstraZeneca COVID-19 vaccine for three weeks while it investigates reports of the shot causing blood clots. Two people died in the country after receiving AZ shots but no link has been established. Last week, when the European Medicines Agency endorsed the safety of the AZ vaccine, most countries that had suspended use of the shot resumed it.
It didn’t take AstraZeneca long to respond to the NIAID’s challenge of its trial results for its COVID-19 vaccine. On Wednesday, the company released new data showing efficacy figures comparable to those announced on Monday, when it showed 79% effectiveness against symptomac COVID and 100% effectiveness against severe COVID. The new data shows a 76% symptomatic efficacy rate, including 85% efficacy among those 65 and older. The 100% mark against severe cases remains intact. The NIAID contended that some outdated information skewed the results in favor of the vaccine. Story
Thermo Fisher has developed a device which can monitor airborne viruses, including the coronavirus. The AerosolSense Sampler is designed to help hospitals, schools, nursing homes, offices and other high-traffic areas get an early warning that a virus is present and allow them to take appropriate measures to keep their environments safe. Story
With the European Union struggling to vaccinate its populace and AstraZeneca failing to live up to vaccine supply promises, many in Europe are asking who is to blame. Adam Parsons of Sky News analyzes the issue with revealing quotes from diplomats and other insiders.
UPDATED: Thursday, March 25 at 11:28 a.m.
Due to the increase of coronavirus variants in the United States, Eli Lilly and the FDA have agreed to halt distribution of bamlanivimab, Endpoints News reports. Lilly will continue to supply the drug in combination with etesevimab, and Regeneron can proceed with its antibody cocktail. The decision comes a week after the FDA halted distribution of bamlanivimab to California, Nevada and Arizona due to prevalence of variants.
Merck KGaA’s berzosertib has been shown to block the ability of the coronavirus to replicate, according to a study by the German drugmaker and UCLA. The treatment is currently used in combination with chemotherapy to treat ovarian and small-cell lung cancer. UCLA researchers screened 430 drugs and found berzosertib to be the most effective candidate versus COVID-19.
AstraZeneca said that of its 29 million COVID-19 vaccine doses found at a Catalent site in Italy, 16 million are bound for the European Union and 13 million are destined for four nations in the COVAX relief effort. Both companies said there was nothing unusual about the amount stockpiled. Story
Former Operation Warp Speed co-leader Moncef Slaoui has taken a leave of absence from all of his professional responsibilities and apologized after a sexual harassment claim forced his exit from GlaxoSmithKline’s Galvani Bioelectronics. Story
UPDATED: Wednesday, March 24 at 3:03 p.m.
With infections rising and domestic needs mounting, India is blocking exports of the AstraZeneca COVID-19 vaccine from the company’s manufacturing partner, the Serum Institute of India. The move will affect the World Health Organization’s COVAX effort to supply shots to needy countries. Of the 60.5 million doses India has shipped, 17.7 million have gone to COVAX, which has an agreement in place to receive 1.1 billion doses from AZ and its partners.
On Wednesday, India reported 47,000 new coronavirus cases and a country-record 275 deaths. It’s an alarming uptick from January when on many days the country reported fewer than 10,000 cases. The country has tightened restrictions and is conducting random testing at the Delhi airport and some rail stations. In addition, though it is not responsible for the current rise in cases, a new “double mutation” COVID variant has been discovered in the country.
German chancellor Angela Merkel has backed off an announced plan to lock the country down for five days around Easter. Business now can be open on Thursday and Saturday of the holiday weekend. The country has seen coronavirus cases increase steadily throughout this month, along with more evidence of spread of the British variant of the disease.
Former Operation Warp Speed co-leader Moncef Slaoui has been terminated from the board of GlaxoSmithKline’s Galvani Bioelectronics for a sexual harassment claim. Slaoui, who received acclaim and criticism for his role in guiding the U.S. effort to speed vaccines to the market, has been under investigation by GSK since February when an accuser notified the company of an incident which occurred several years ago. GSK categorized the behavior as an abuse of leadership. Slaoui remains the chief scientific officer of startup Cenressa Pharmaceuticals. Story
Pfizer has begun testing an oral antiviral treatment which it hopes will be effective in neutralizing coronavirus in recently infected patients. The older protease inhibitor has been tested for years against HIV and hepatitis C. One advantage: The drug can be prescribed and taken at home as opposed to the current crop of available antibody treatments, which are administered in infusion clinics or hospitals. It follows similar efforts by Merck and Regeneron (molnupiravir) and Roche and Altea (AT-527). Story
CureVac’s mRNA COVID-19 vaccine candidate registered strong results against the highly infectious South African variant when tested on mice. On Monday, CureVac announced it would expand a trial in Europe and Latin America to analyze the vaccine’s efficacy against select variants. Story
UPDATED: Wednesday, March 24 at 10:54 a.m.
Authorities in Italy have found 29 million doses of AstraZeneca COVID-19 vaccine stockpiled at a Catalent fill-finish facility in Anagni. The discovery was made after the European Union noticed a discrepancy between supply outputs reported by the company and the individual manufacturing facilities. According to the daily La Stampa, some of the discovered doses were produced by Halix in the Netherlands. The EU has been at odds with AZ over the company’s failure to deliver on its promised 100 million vaccine doses in the first quarter. To date, Europe has received just 16.6 million doses as vaccination rates lag far behind those of the United States and the U.K.
The Chinese territories of Hong Kong and Macao have suspended use of the Pfizer-BioNTech COVID-19 vaccine because of a packaging flaw—a vial cap defect. Fosun Pharma, which manufactures and distributes the shot in China, is investigating along with BioNTech. Of 585,000 doses in the batch in question, 150,000 vaccines have been distributed. A subsequent batch of 758,000 doses has been put on hold. Officials don’t believe there is a safety issue, but they've suspended us of the vaccine as a precaution. Both territories received their first shots a month ago. With the news, Fosun’s shares tumbled by nearly 5%.
With Moderna bringing its first product to market—a COVID-19 vaccine—it's been a transformational year for the company and its sudden-billionaire CEO Stéphane Bancel, who told Forbes, “In 2021 and 2022 Moderna is going to scale at a pace that has never happened before in biotech.” Bancel discussed the future for the company and mRNA technology, which includes developing more COVID vaccines, a better flu shot and new ways to treat cancer and heart disease.
Australia is distributing its first batch of domestically produced COVID-19 vaccines after CSL Seqirus’ fill-finish site in Melbourne released 830,000 doses of the AstraZeneca shot. In cold storage are 2.5 million doses undergoing final testing before their release. Manufacture of bulk substance began in November at CSL Behring’s site in Broadmeadows.
U.S. regulators have cleared a Catalent plant in Bloomington, Indiana, to produce the single-shot COVID-19 vaccine for Johnson & Johnson. The approval will allow J&J to dramatically bump up production. The company pledged 20 million doses to the U.S. by the end of March, but it's delivered only 4.5 million. Story
Researchers at Michigan Medicine have found that flu shots may help derail the coronavirus. Of 27,000 patients, none tested positive for both viruses at the same time. While those who received flu shots were slightly less likely to contract the coronavirus, they were significantly less likely to develop severe cases of the disease.
In a pandemic-riddled year, German biopharmaceutical firm Boehringer Ingelheim accelerated efforts to research COVID-19 related therapies, spending more than $4.3 billion on R&D—a record-high for the 136-year-old company. In its annual summary, BI posted $23.16 billion in revenue, a 3% increase from 2019.
UPDATED: Tuesday, March 23 at 3:32 p.m.
Texas will make all adult residents eligible to receive the coronavirus vaccine, becoming the fourth state to do so, joining Alaska, Mississippi and West Virginia. The move takes effect on Monday, well ahead of President Joe Biden’s May 1 target to open vaccinations to all adults.
With Europe entering a third wave of the coronavirus, Germany has intensified a lockdown centered around Easter. Shops will be closed for five days around the holiday weekend and restrictions have been extended to April 18. The move is a U-turn from earlier this month when the country relaxed restrictions.
Regeneron and Roche posted strong results in a phase 3 trial of their COVID-19 antibody combo. The treatment, a cocktail of casirivimab and imdevimab, lowered the risk of hospitalization or death in high-risk non-hospitalized patients by 70%. It also retained its potency against five major variants and at three different doses. It gained emergency use authorization in November. The new data will aid in the treatment’s battle with Eli Lilly’s combination of bamlanivimab and etesevimab, which also has received an EUA. Story
The high-profile missteps of COVID-19 vaccine producer AstraZeneca during the pandemic continue to dominate headlines. The most recent news of the company using outdated data in reporting trial results prompted even the most measured observers to use terms such as “unprecedented” and “speechless” to describe their astonishment. Here’s a look at the AZ’s problems from a PR perspective. Story
The Leiden, Netherlands, manufacturing facility at the center of a disagreement between the European Union and the U.K. is set to come online for coronavirus vaccine production and receive approval from the EU’s regulatory agency, according to Rudd Dobber, the president of AZ’s BioPharmaceuticals business. The EU threatened to block exports from the plant until AZ lived up to its supply shortfall in Europe. Story
Getting a home-delivered coronavirus test will soon be as easy as having a pizza brought to your front door. Food delivery service DoorDash will include COVID-19 test kits on its phone app. The company has partnered with Everlywell and Vault Health, two companies that have developed FDA-approved at-home test kits, which promise results in less than 48 hours. Story
UPDATED: Tuesday, March 23 at 12:02 p.m.
The European Union and the U.K. are discussing a proposal to share exports of the AstraZeneca vaccine from a manufacturing facility in the Netherlands. This is an attempt to break a deadlock between the two. The EU has threatened to block exports of the vaccine until its supply obligations have been met. Both the EU and U.K. believe they have legal claims and that AstraZeneca has double booked its production.
AstraZeneca may have touted outdated information in reporting results of a trial of its COVID-19 vaccine, according to the National Institute of Allergy and Infectious Diseases. The revelation touched off another controversy for the company, and AZ said it plans to submit new findings within 48 hours. Story
After the success of Pfizer and BioNTech in developing a COVID-19 vaccine, Pfizer will attempt to use mRNA technology to develop other vaccines and will do it solo, CEO Albert Bourla told the Wall Street Journal. “We are the best positioned company right now to take it to the next step because of our size and expertise,” he said.
UPDATED: Monday, March 22 at 4:23 p.m.
The push to manufacture COVID-19 vaccines is affecting supplies of some critical medicines. Pfizer for instance has notified hospitals to expect supply interruptions on four of its products—an antibiotic, a steroid and two testosterone treatments. All of them are biologic medicines that use some of the same ingredients and manufacturing capacity as the COVID vaccine.
The European Medicines Agency has advised against the use of ivermectin for prevention or treatment of coronavirus. In testing, the drug has shown ability to block replication of SARS-CoV-2, but at much higher doses than authorized. The drug is used in tablet form for treating worm infestations and as an ointment for skin conditions. It is also used for veterinary use for internal and external parasites. The EMA concluded that ivermectin use should be limited to clinical trials.
Egypt is nearing an agreement to produce the COVID-19 vaccine from Sinovac Biotech of China. Egypt hopes to become a center for manufacturing the vaccine for both local use and export to countries in Africa. Sinovac has supplied 160 million doses at home and around the world. Egypt has received less than 1 million vaccine doses, donated by China’s state-run Sinopharm.
On a Twitter post, Russia has accused the European Union of “bias” against its COVID-19 vaccine, Sputnik V. The message came after the EU’s internal market commissioner Thierry Breton said the bloc had “absolutely no need” for the vaccine. The spat comes after EU members Slovakia and Hungary issued emergency approval of Sputnik V, bypassing the EU. Tensions between Russia and the EU escalated after Europe’s jailing of Russian opposition activist Alexei Navalny last month. Russia retaliated by sending home three diplomats from EU countries.
AstraZeneca expects the European Union’s regulator to approve a factory in the Netherlands that could help ease the supply problems.
While some pharma companies were major players in the development of vaccines and treatments for COVID-19 and others weren’t, the pandemic impacted all drugmakers who had to deal with sudden changes wrought by work-at-home orders and medical office closures. Those factors plus the usual pharma concerns about pricing and regulatory issues make for a year of tumult in the industry. Story
The FDA has approved a digital armband—similar to a fitness wearable—which can screen people for COVID-19. The AI-powered device by Tiger Tech Solutions uses light sensors to detect blood flow and within three to five minutes can determine if blood is clotting more freely than usual, which is a sign of coronavirus infection. Story
UPDATED: Monday, March 22 at 10:57 a.m.
European Commission president Ursula von der Leyen said the European Union had the power to ban exports of the AstraZeneca COVID-19 vaccine if the drugmaker didn’t meet its obligations in supply-strapped Europe. While only 12% of adults in Italy, Germany and France have been vaccinated, Britain has inoculated half of its adult population, per an announcement on Saturday. Pfizer weighed in as well, warning the EU not to block vaccine exports as it has its own supply deals to meet.
Daiichi Sankyo has kicked off a phase 1/2 trial of its mRNA coronavirus vaccine candidate in Japan. Earlier this month, Daiichi began producing COVID-19 vaccines for AstraZeneca. Daiichi has agreed to fill-finish 120 million doses for distribution in Japan. Story
In a phase 3 trial conducted in the United States, Peru and Chile, the AstraZeneca COVID-19 vaccine was 79% effective preventing symptomatic coronavirus and 100% effective against severe cases, with no safety issues. The trial included 32,000 volunteers and moves the shot a step closer to approval in the United States. Story
CureVac will expand and modify its ongoing late-stage trials of its COVID-19 vaccine candidate to measure its effectiveness against emerging variants and its efficacy in the elderly. In the phase 2b/3 trial in Europe and Latin America, the rapid spread of new virus variants supports the need for further analysis to determine the efficacy of the vaccine against particular strains. For its phase 2a trial in older adults in Peru and Panama, CureVac has submitted an amendment to include a secondary objective for vaccine efficacy in 270 participants above the age of 60.
Russia continues to look to India to produce its Sputnik V coronavirus vaccine. Virchow Biotech is the latest company to agree to a supply deal, signing up to provide 200 million doses per year. The ramp up is expected to be complete by the end of the second quarter. Russia also has made similar deals with Indian manufacturers Stelis, Gland and Hetero. The four deals will provide for approximately 750 million doses this year. The vaccine has been registered in 51 countries.
UPDATED: Friday, March 19 at 2:48 p.m.
When the European Medicines Agency reiterated the safety of the AstraZeneca coronavirus vaccine on Thursday, nearly a dozen countries that had suspended use of the shot—including Germany, France and Italy—quickly resumed vaccinations. But some countries have been hesitant to follow suit and one of them, Finland, is defying the proclamation, suspending use of the AZ vaccine on Friday while it investigates two cases of recipients developing blood clots.
Meanwhile, Denmark, Sweden and Norway are in no rush to restart their AstraZeneca vaccine rollouts, saying the situation warrants more study.
On Friday, the U.S. was expected to pass the 100 million mark in coronavirus vaccine doses administered, comfortably outpacing the goal set by President Joe Biden, whose original target was to reach the benchmark by his 100th day in office. Friday is his 58th day. Biden said he would announce a new goal for the U.S. next week.
Along with partner Novartis, Incyte will give Jakafi another go as a treatment for COVID-19 patients. The drug, which is approved for use in polycythemia vera, myelofibrosis and graft-versus-host disease, failed to perform as hoped in a phase 3 trial but showed enough value in preventing death in severely ill patients in the U.S. to warrant access through a managed care program. Story
UPDATED: Friday, March 19 at 10:31 a.m.
U.S. neighbors Mexico and Canada will be the first recipients of America’s unused stock of AstraZeneca coronavirus vaccines. Mexico will get 2.5 million doses and Canada will receive 1.5 million doses. More than 30 million doses of the AZ vaccine produced domestically are in warehouses while the shot awaits authorization from the FDA.
There are four primary sources of coronavirus vaccine production. Axios tabulated how many shots China (169 million), United States (136 million), Europe (96 million) and India (68 million) have produced. While the U.S. is set to send its first shipments abroad, exports have accounted for 60% of the stock produced by China and 65% by India.
With coronavirus cases rising in Germany and the country facing a desperate need for vaccines, health minister Jens Spahn said he would support a national supply deal with Russia for its Sputnik V vaccine even though it has not been approved by the European Union. “I am actually very much in favor of us doing it nationally if the European Union does not do something,” Spahn said. German chancellor Angela Merkel will meet with state leaders on Monday to establish new shutdown rules. This month in Germany, weekly cases per 100,000 have risen from 65 to 96.
With coronavirus cases rising in France, president Emmanuel Macron has imposed a month-long lockdown in Paris and other regions. Other restrictions will have to be reestablished after Macron relaxed them in late January in an attempt to stimulate the sagging economy.
Stelis Biopharma of India will produce 200 million doses of Russia’s Sputnik V vaccine. The deal comes on top of Gland Pharma of India agreeing this week to manufacture 252 million doses of the vaccine, which has been approved for use in 50 countries. Production for both deals will commence in the third quarter of this year.
The FDA has granted its first full approval to a coronavirus diagnostic kit. BioFire got the nod for its nasal swab test. The approval will make the path easier for similar products to get full clearance. More than 340 COVID-19 diagnostic tools have received emergency use authorization. Story
A new COVID-19 test, launched by Roche, will help researchers monitor emerging variants and track mutations that make the disease more transmissible and fatal. Story
UPDATED: Thursday, March 18 at 2:45 p.m.
Amid reports of blood clots and 15 countries halting its use, the European Medicines Agency has declared the AstraZeneca COVID-19 vaccine “safe and effective.” The EMA said it couldn’t “definitively” rule out a link between the shot and rare blood clots, so it's moving raise awareness of possible risks. Leaders in France and Italy said earlier this week that they would reinstate use of the vaccine if it was endorsed by the EMA. Story
The U.S. has halted distribution of Eli Lilly’s COVID-19 antibody treatment bamlanivimab in Californa, Arizona and Nevada because of concerns over the spread of a variant. The policy extends only to sales of bamlanivimab alone. Lilly’s combination of bamlanivimab and etesivimab remains available in all states. The news comes after the FDA ordered Lilly and Regeneron to monitor their antibody treatments' effectiveness against variants. Story
The pharma industry has traditionally scored poorly in public opinion polls, but that’s changing thanks to its rapid response to the coronavirus pandemic. As a result, many pharma and biotech companies are looking for ways to optimize their corporate images, according to an expert in the field. Story
UPDATED: Thursday, March 18 at 10:45 a.m.
A Sanofi exec said he hopes collaboration among major drugmakers will cast a better light on the drug industry, which is often criticized for its high prices. "I think it's showing to the world that sometimes this industry that can be, sometimes, a little bit differently perceived in the media ... what we have at the heart of this industry," EVP and vaccines chief Thomas Triomphe told Yahoo France. After its first COVID-19 vaccine candidate stalled in development, Sanofi signed up to fill-finish shots made by other companies. A Sanofi site in Germany services the Pfizer-BioNTech coronavirus vaccine, while a plant in France does the same for the Johnson & Johnson vaccine.
A supply shortfall is threatening to push back the U.K.’s plan for COVID-19 vaccinations. The National Health Service warned local health organizations of reduced supplies in April. A shipment from the Serum Institute of India has been delayed for four weeks. Another batch of 1.7 million doses from Serum needs to be retested for stability. The plan to offer vaccines to people over age 50 on April 15 and to all adults by the end of July remains intact.
Merck KGaA plans to amp up production of single-use materials used in manufacturing COVID-19 vaccines. The German drugmaker will add a single-use assembly unit at its manufacturing site in Molsheim, France. The new capacity will come online in the fourth quarter of this year and will become the company’s first facility in Europe to turn out the materials. The $30 million investment will include 350 new employees. Merck KGaA facilities in Danvers, Massachusetts, and Wuxi, China, are already manufacturing the materials.
Gland Pharma of India has agreed to supply 252 million doses of Russia's Sputnik V COVID-19 vaccine. Production is expected to begin the third quarter of this year. The vaccine has been approved in 22 countries. Another Indian firm, Hetero, will produce 100 million doses of the Sputnik shot.
An Oxford study shows that existing vaccines may protect against the Brazilian variant of the coronavirus more effectively than first believed. The study measured the level of antibodies that can neutralize variants and examined the performance of natural antibodies of those who had been infected with COVID-19 vs. vaccine-induced antibodies.
A former Pfizer executive co-authored a petition to the European Medicines Agency last fall demanding that COVID-19 vaccines be halted because they could cause infertility in women. Michael Yeadon, 60, a former Pfizer researcher and VP who co-founded a biotech later purchased by Novartis, was a driving force behind the movement. The petition, which cited no evidence and appeared Dec. 1 on a German website, failed to sway regulators who approved of the Pfizer-BioNTech vaccine weeks later, according to a Reuters special report.
Sudden onset hearing loss has occurred in some recipients of COVID-19 vaccines. The condition, which strikes 11 to 77 per 100,000 people yearly in the U.S., has been registered 14 times among the 31,000 entries in the new Vaccine Adverse Event Reporting System. Many of the cases have come within the first two weeks of inoculation and the effects have been temporary. It’s too soon for experts to establish a link.
UPDATED: Wednesday, March 17 at 4:12 p.m.
The World Health Organization reiterated its support for the AstraZeneca COVID-19 vaccine on Thursday, saying that its benefits outweigh risks. The WHO’s Global Advisory Committee on Vaccine Safety will continue to assess data.
Clofazimine, which was approved by the FDA in 1986 for the treatment of leprosy, significantly reduced viral load and shedding in hamsters, indicating it might be effective fighting COVID-19. The University of Hong Kong has launched a phase 2 study testing a combination of clofazimine and interferon beta on hospitalized patients. Story
Governments are intent on building up their vaccine and biologics infrastructure to insulate themselves from the kind of supply disruptions witnessed during the COVID-19 pandemic, according to Stefan Oschmann, the CEO of Merck KGaA. Story
UPDATED: Wednesday, March 17 at 9:45 a.m.
A double dose of AstraZeneca's vaccine was just 10.4% effective against mild-to-moderate infections with the B1351 variant identified in South Africa, a phase 1b-2 study published in the New England Journal of Medicine found. Out of 750 people who received the vaccine, 19, or 2.5%, developed mild-to-moderate disease more than 14 days after the second dose, versus 23 infections among the 717-subject placebo arm. Of the 42 COVID-19 cases reported, 39, or nearly 93%, were caused by B1351.
Once COVID-19 moves "from a pandemic situation to an endemic situation," Pfizer sees "significant opportunity" for its vaccine "from a pricing perspective," Frank D'Amelio, CFO & executive VP of global supply, said at a Barclays virtual healthcare conference last week. Once the pandemic phase subsides, normal market conditions will start to kick in, and D'Amelio predicts Comirnaty's strong clinical profile will put it in high demand. Story
Catalent will expand its production capacity in Europe to manufacture the Johnson & Johnson COVID-19 vaccine. A plant in Anagni, Italy, will bring on a second production line in the fourth quarter of this year. Story
States are hustling to expand vaccine access after President Joe Biden last week said he would order them to make all adults eligible for the shot by May 1. Maine, Virginia and Wisconsin, as well as Washington D.C., have pledged to meet that deadline, while Colorado, Connecticut, Ohio, Michigan, Montana and Utah aim to expand access before then. Since December, the U.S. has delivered some 143 million vaccine doses to states and territories, the CDC says. It's now averaging about 2.4 million shots a day, more than double its distribution output in January.
President Biden said he is in talks with several countries about distributing surplus COVID-19 vaccines. He previously said he intends to ensure all Americans have access to vaccinations before shipping available stock overseas. Mexico has requested America’s unused AstraZeneca shots; the shot isn't approved in the U.S. but is in use in Mexico.
Ships will duke it out with planes to deliver COVID-19 vaccines this year as air freight capacity is exhausted and shots make their way to Africa, Asia and South America, the head of pharmaceuticals at the container group Maersk told the Financial Times. By the middle of the year, Maersk's Hristo Petkov predicts half of all vaccine distribution will occur locally via trucks and short-haul flights, with ships and planes battling over the remaining half. Land and air have prevailed in the distribution push so far because the factories making those vaccines are mainly based in Europe, India and the U.S.—close to early recipients.
French President Emmanuel Macron and Italian prime minister Mario Draghi said they will restart the use of the AstraZeneca COVID-19 vaccine if it is cleared by the European Medicines Agency. The countries are among 15 in Europe that have stopped administering the shot based on reports of blood clots.
Meanwhile, the EMA is expected to grant AstraZeneca's vaccine safety clearance Thursday. The investigation is still ongoing, but the agency remains "firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 ... outweigh the risks of these side effects," said Emer Cooke, executive director of the EMA.
Plus, France faces "a kind of third wave" of COVID-19 infections, Prime Minister Jean Castex said Tuesday, linking the surge to emerging virus variants. The country is grappling with widely reported mutants from the U.K., South Africa and Brazil, and also has concerns about a new variant in Brittany, which it classifies as a "variant under investigation." The variant doesn't seem to increase transmissibility or disease severity, according to a first analysis.
UPDATED: Tuesday, March 16 at 3:03 p.m.
The FDA has altered its emergency use authorizations for Eli Lilly and Regeneron's COVID-19 antibody drugs and is now requiring the companies to monitor emerging coronavirus variants and to potentially test their drugs against them. The guidance applies to Regeneron’s combination of casirivimab and imdevimab and to Lilly’s bamlanivimab and its combo treatment of bamlanivimab and etesevimab. All of the drugs are for patients with mild to moderate cases of COVID-19. Coronavirus variants, especially the South African strain, have shown increased resistance to antibody treatments. Story
Maryland-based Emergent BioSolutions will receive aid from the Canadian government as it expands its plant in Winnipeg. The factory already has the capability of manufacturing vaccines, including COVID-19 shots. The deal could provide Canada with its first domestic plant manufacturing COVID-19 vaccines. Story
AstraZeneca’s COVID-19 vaccine is under relentless fire, but analysts from Jefferies believe the company is positioned well because of its pipeline of promising drugs and the strength of its oncology offerings. Story
UPDATED: Tuesday, March 16 at 11:03 a.m.
Pfizer-BioNTech’s total supply of COVID-19 vaccine doses to Europe will reach 200 million by the end of the second quarter, according to European Commission president Ursula Von der Leyen. Reuters confirmed the figure with Pfizer. The shipments include 10 million doses, previously earmarked for later delivery, that will be expedited. Also in the second quarter, the EU expects to receive 55 million doses of the single-shot Johnson & Johnson vaccine and 35 million doses of the Moderna shot. Europe hopes to have 70% of its population vaccinated by the end of the summer.
AstraZeneca has modified an agreement with the United States to supply up to 500,000 additional doses of AZD7442, an experimental, long-acting antibody combination for the prevention and treatment of COVID-19. This deal builds on an October contract to support late-stage development of the drug and an initial supply of 100,000 doses. AZ already had a pact with the DoD to supply 100,000 doses of the drug.
Moderna has dosed the first children in a phase 2/3 study of its mRNA vaccine. The study, conducted along with the NIH, includes kids between the ages of 6 months and 11 years in the United States and Canada. It will include approximately 6,750 participants.
The FDA has launched a website to track side effects from COVID-19 treatments that have received emergency use authorization. The FDA Adverse Event Reporting System is a public dashboard that will be updated weekly. In its debut week, the dashboard registered 8,627 reports with 5,000 determined to be serious and an additional 1,404 reporting a death. Story
Maryland-based Emergent BioSolutions will receive aid from Canada as it expands its plant in Winnipeg. The factory can already manufacture vaccines, including COVID-19 shots.
Sweden and Latvia joined a growing list of European countries that have suspended use of the AstraZeneca COVID-19 vaccine. Sweden’s move is pending a report from the European Medicines Agency, expected later this week. The European Union’s three largest countries—Germany, Italy and France—discontinued use of the shot on Monday. Meanwhile, Venezuela said it would not authorize use of the AZ vaccine.
The World Health Organization’s committee on vaccine safety will meet on Tuesday to discuss the AstraZeneca COVID-19 shot and reports of it causing blood clots. Meanwhile, WHO’s chief scientist Soumya Swaminathan urged people not to panic, saying that the incidence of blood clots to AZ vaccine recipients has been “less than what you would expect in the general population.”
AstraZeneca chief Pascal Soriot is on the “hot seat" over delivery delays of its COVID-19 vaccine, according to France’s industry minister Agnes Pannier-Runacher. The company originally agreed to provide 90 million doses to the European Union by the end of March but revised that number to 30 million last week.
UPDATED: Monday, March 15 at 3:10 p.m. PM
Problems continue to mount for AstraZeneca’s COVID-19 vaccine. On Monday, Germany became the largest country to join the growing list of those suspending use of the shot. The company has been beset with supply problems, especially in Europe. And confidence in the vaccine is declining with reports of it causing blood clots. Over the weekend, the company issued a statement defending the jab’s safety. Story
In another bit of negative news regarding AstraZeneca’s COVID-19 vaccine supply shortfall in Europe, the company’s revised goal of providing 30 million doses of the shot, which is 60 million fewer than originally promised, is not even assured. The new target hinges on the European Union’s regulator approving supplies from a factory in the Netherlands, according to an internal document.
Results from a 30,000-person U.S. trial of AstraZeneca’s COVID-19 vaccine are under review and if positive could clear the way for approval in a month, according to NIH director Francis Collins.
Moderna was quick to develop a COVID-19 vaccine. Now it has started phase 1 testing of its next-gen mRNA COVID-19 vaccine, which would be refrigerator stable and easier to distribute and administer than its current shot.
Early commercial batches of the Pfizer-BioNTech COVID-19 vaccine had lower levels of mRNA than clinical batches, which prompted major concerns for regulators from the European Medicines Agency before the shot was approved. The information came by way of an EMA cyberattack which was leaked to journalists. While the production issue has been resolved, the incident demonstrates the complexities of quality assurance for mRNA vaccines. Story
After one failed attempt to develop a COVID-19 drug, Molecular Partners and Novartis have partnered again for another try. On Monday, they announced that ensovibep will be included in an NIH global phase 3 clinical trial, ACTIV-3, which evaluates therapies for the treatment of adults hospitalized with COVID-19. Story
Customers visiting Black-owned barbershops in New York, Chicago and the Raleigh-Durham area will get more than a haircut. They’ll also get facemasks, hand sanitizer and information on how to join a treatment trial if they become infected with COVID-19. The marketing effort is by ACTIV, a public/private initiative created by the NIH to help overcome the community’s distrust of the medical field, especially in regard to trials and experiments. Story
UPDATED: Monday, March 15 at 10:57 p.m. ET
The European Union will begin depending more on Pfizer and BioNTech for its COVID-19 vaccine supply, according to EU industry commissioner Thierry Breton. The news came shortly after AstraZeneca warned the EU of a supply shortfall. The company had originally pledged to deliver 90 million vaccine doses by the end of the first quarter but told the EU on Friday to expect only 30 million doses to arrive by the end of March.
With some countries refusing to administer the AstraZeneca COVID-19 vaccine, the company issued a strong written response defending its safety. Data from more than 17 million vaccine doses showed “no evidence of increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” according to the release. The number of reported cases of DVT (15) and pulmonary embolism (22) is “much lower than would be expected to occur naturally in a general population of this size,” added the release. Story
Three people in Norway have been hospitalized with blood clots after receiving the AstraZeneca COVID-19 vaccine. The country was among seven in Europe which last week shut down vaccines with all or part of their available AZ stock. The European Medicines Agency will investigate.
Add Ireland and the Netherlands to the growing list of countries that have suspended use of the AstraZeneca COVID-19 vaccine. Both countries took the action after reports of three vaccine recipients in Norway being hospitalized with blood clots. On Friday, Thailand became the first country outside of Europe to halt vaccinations. Ireland’s chief medical officer Ronan Glynn said: “We may be overreacting. ... Hopefully we will have data to reassure us in a few short days and we will be back up and running with this.”
The U.S. will continue to sit on its stockpile of the AstraZeneca COVID-19 vaccine amid pressure to send the supply overseas. The AZ shot has yet to be approved in the U.S. “We have a small inventory of AZ so that, if approved, we can get the inventory out to the American people as quickly as possible,” said COVID-19 response coordinator Jeff Zients, in a press briefing. “We’re rightly focused on getting Americans vaccinated as soon as possible.”
Takeda announced a mutual agreement with IDT Biologika and Johnson & Johnson for the Germany-based CDMO to manufacture the J&J COVID-19 vaccine. Takeda had originally reserved IDT to produce its dengue fever vaccine, which is subject to regulatory approvals. The agreement with J&J extends over the next three months.
Novo Nordisk is in preliminary talks with the Danish government to establish local vaccine production. The news comes after prime minister Mette Frederiksen expressed concern over delays in the European Union in supplying COVID-19 vaccines. Novo Nordisk has production facilities in eight countries.
Molecular Partners AG and Novartis announced that its COVID-19 drug ensovibep will be included in an NIH global phase 3 clinical trial. ACTIV-3 evaluates various therapies for the treatment of adults hospitalized with COVID-19. Ensovibep binds the receptor-binding domain of the SARS-CoV2 spike protein to prevent entry into cells and may provide added protection against variant strains.
Facebook has launched a global campaign to help people get vaccinated. The Covid Information Center will appear in users’ news feeds with a link to schedule an appointment. Facebook also will bring the information center to Instagram and is urging governments to expand their WhatsApp chatbots to help people register.
UPDATED: Friday, March 12 at 3:59 p.m. ET
AstraZeneca is set to request emergency use authorization from the United States for its COVID-19 vaccine. The request will come later this month or in early April, Reuters reports.
AstraZeneca has revised its estimate for delivery of its COVID-19 vaccine to Europe in the first quarter and the news isn’t good. After originally agreeing to supply 90 million vaccine doses in the first quarter, the company on Friday said only 30 million will be possible. Story
In a related report, the European Union has been told not to expect supplies of the vaccine anytime soon from AZ’s manufacturing facilities in the United States.
Also with regard to the AZ vaccine, Germany and a few other large European countries are expressing disappointment in countries that have suspended use of all or some of their vaccine supplies from the company.
Piloting Pfizer through its rapid and successful response to the COVID-19 pandemic has paid off for Albert Bourla. The Pfizer CEO collected more than $21 million last year, according to a proxy filing submitted Friday. The company is eyeing $15 billion in COVID-19 vaccine sales this year. Story
Also on Bourla, the Pfizer chief said it was a “question of weeks” until kids ages 12-16 could start receiving the COVID-19 vaccine, pending approval from the FDA. Pfizer recently enrolled more than 2,000 children ages 12-15 in clinical trials. Further, praising the efforts of Israeli prime minister Benjamin Netanyahu to secure Pfizer vaccines, Bourla said the prime minister "called me 30 times.”
Analysts from Jefferies took a detailed look at how pharma companies have fared during the coronavirus pandemic and assessed their fitness to deal with another crisis. Some products, such as GlaxoSmithKline’s Shingrix, suffered because older adults were hesitant to visit clinics. Others, like Sanofi’s flu shots, thrived. Overall, companies best suited to a crisis are ones with a diversified portfolio of drugs. Story
Jefferies further lays out a case that companies could benefit from products that combat “long COVID” problems, including mental health, lung scarring, kidney disease and heart failure.
In phase 2 and 3 testing, Novavax’s COVID-19 vaccine showed vastly different efficacy protection rates against the British (86%) and South African (49%) variants. But regardless of the strain, the vaccine was 100% effective in preventing severe forms of the disease. Of 10 people who developed severe COVID-19 cases, all were placebo recipients. Story
Altimmune has expanded its manufacturing agreement with Lonza to produce its AdCOVID intranasal vaccine candidate. Lonza’s facility in Houston, Texas, will handle clinical and commercial production. The vaccine has been shown in early studies to activate mucosal immunity which could prevent infection and transmission of the disease.
UPDATED: Friday, March 12 at 11:18 a.m. ET
Thirty million doses of the AstraZeneca COVID-19 vaccine are sitting in a facility in Ohio while other countries are asking to use them, The New York Times reports. The AZ shot has yet to be approved in the U.S. There are discussions within the government about the risk of expiration as the shelf life of the AZ jab is six months. Possible solutions are to ship them to Europe or COVID-ravaged Brazil.
Pfizer and Moderna are scheduled to have delivered 100 million COVID-19 vaccine doses to the U.S. each by the end of March. So how are they doing? As of Wednesday afternoon, Moderna had supplied 64 million doses while Pfizer had supplied 61 million. While deliveries lagged early in the year, they’ve stepped up dramatically. Over the last two weeks, both companies have provided 20 million weekly doses each. Continuing that trend would allow both to meet the goal.
Pfizer-BioNTech announced that real-world data from Israel shows that their COVID-19 vaccine is 94% effective in preventing asymptomatic infections, meaning it could significantly reduce transmission. The vaccine also was 97% effective in preventing severe disease and death. In addition, data shows better than 80% efficacy against the British variant of the coronavirus.
Sanofi and Translate Bio announced a phase 1/2 trial for their mRNA COVID-19 vaccine candidate. The companies expect results in the third quarter of this year. Story
Pfizer-BioNTech will supply Japan with 100 million doses of its COVID-19 vaccine by June, a month before the Olympic Games are scheduled to begin in Tokyo. In May, Japan expects to receive 10 million doses per week from Pfizer, followed by increased amounts in June. This order will allow Japan to inoculate 50 million people, half the country’s population. The International Olympic Committee has said it will not jump the line to vaccinate athletes.
Daiichi Sankyo has begun manufacturing the AstraZeneca COVID-19 vaccine in Japan, filling vials and packaging them for shipment. AZ has agreed to supply Japan with 120 million vaccine doses, 30 of which will be provided through Daiichi Sankyo and KM Biologics. Production of the other 90 million doses will be handled by JCR Pharmaceuticals.
ApiJect Systems announced that Raymond J. Guidotti is its new Chief Operating Officer. He brings 30 years of pharma experience, most recently at Thermo Fisher, to the company that specializes in vaccine production.
UPDATED: Thursday, March 11 at 4:24 p.m. ET
Europe has approved the Johnson & Johnson single-shot COVID-19 vaccine, accepting the recommendation of the European Medicines Agency from earlier in the day. It is the fourth coronavirus vaccine endorsed by the EU, joining the two-shot vaccines from Moderna, Pfizer-BioNTech and AstraZeneca.
Vir Biotechnology and GlaxoSmithKline announced that a trial evaluating VIR-7831 as a therapy for early treatment of high-risk COVID-19 patients has been stopped due to profound efficacy. Based on 85% success, the companies will apply for emergency use authorization from the FDA. Story
A Merck facility in Durham, N.C. will produce bulk substance for manufacture of the Johnson & Johnson COVID-19 vaccine and will receive $105.4 million from the U.S. government for upgrades. The two pharma giants entered into a “wartime” agreement last week allowing J&J to increase vaccine production. Story
Seven countries in Europe have halted distribution of some or all of their AstraZeneca COVID-19 vaccine supplies. Austria started the wave after a clotting issue turned up in one recipient. Then Estonia, Latvia, Lithuania and Luxembourg stopped using vaccines from the same batch. Denmark and Norway followed suit, halting all AZ vaccinations. This is the latest in a series of negative reports about the vaccine which has been plagued by supply shortfalls in Europe and questions about its safety and effectiveness, which have led to unused stock in some countries. Story
In a related story, the European Medicines Agency found no linkage between two people in Austria who became ill after receiving the AstraZeneca COVID-19 vaccine. One of the people, 49, died 10 days after receiving the shot.
There are differing public perceptions about the AstraZeneca COVID-19 vaccine: one in the U.K. and another in the rest of Europe. A poll by YouGov found that 81% of Brits believe the AZ vaccine is safe, even more so than the Pfizer shot (79%). In Germany (43%) and France (33%) however, faith in the AZ jab is much lower. Developed at Oxford, the AZ shot was rolled out in England as a source of public pride. But supply issues, reports of side effects and doubts about the vaccine’s effectiveness among the elderly and safety have chipped away at its reputation in some areas of Europe. Story
Researchers in the U.K. have identified a key inflammatory protein which could be linked to severe COVID-19. In an analysis of more than 500 COVID-19 patients, researchers identified a cytokine (GM-CSF) which was present at higher levels in those who progressed to critical conditions. The protein also was found to be nearly 10 times higher in those who died. Researchers believe this discovery could help detect those most at risk and provide a target for new treatments.
Pfizer will wait until the “pandemic supply phase” is over before considering production of its COVID-19 vaccine outside of Europe and the United States. The statement from the company came after a Reuters report that Pfizer told India that it would produce its shot there if assured of regulatory clearance and freedom on pricing and exports.
We’ve yet to emerge from the coronavirus pandemic, but Abbott is planning for the next one. The company is launching a Pandemic Defense Coalition to detect and track emerging viruses and dangerous mutations. The network will include centers with expertise in lab testing, genetic sequencing and public health. Since the team plans to publish their findings, other scientists will be able to determine if new viruses pose threats.
Jubilant has agreed to terms with Eli Lilly to produce bamlanivimab, a treatment for COVID-19 which recently was granted emergency use approval from the FDA. The drug will be manufactured in Seattle by Jubilant’s subsidiary, Jubilant HollisterStier.
The governors of Colorado and Oregon have asked the FDA to allow COVID-19 vaccine pooling. The strategy combines leftovers from different vials of the same type of vaccine, stretching the supply. The FDA advises against the practice, citing contamination and infection risks. The governors argue the benefits outweigh the risks.
Novartis has invested $23.8 million in its manufacturing site in Kundl, Austria, which will produce COVID-19 vaccines for CureVac. The facility will pump out 50 million doses by the end of this year and up to 200 million in 2022. It also will add up to 100 employees as part of the ramp up.
On the anniversary of the World Health Organization declaring the coronavirus pandemic, Pfizer CEO Albert Bourla wrote in an open letter posted on the company’s website. Bourla recognized the surge of optimism that has accompanied vaccine rollouts but also stressed the importance of maintaining social distance and wearing masks until herd immunity is achieved.
UPDATED: Thursday, March 11 at 11:21 a.m. ET
Europe's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending that the Johnson & Johnson COVID-19 vaccine be approved. Data from the Ensemble study showed the single-shot vaccine was 85% effective in preventing severe disease. The vaccine was authorized by the FDA for use in the United States on Feb. 27. Europe has approved vaccines from Pfizer-BioNTech, Moderna and AstraZeneca.
Phase 3 testing of Roche's Actemra (tocilizumab) as an add-on to Gilead Sciences' remdesivir—now sold as Veklury in the U.S.—failed to top Veklury alone in patients with severe COVID-19 pneumonia. Roche's Genentech unit will continue to evaluate data from this study and others using Actemra on coronavirus patients with pneumonia. Story
Denmark has suspended use of the AstraZeneca COVID-19 vaccine for 14 days after reports of blood clots and one death. The precautionary measure will give experts time to determine whether the incidents are linked to the vaccine. Shots from the same batch were suspended last week in Austria after the death of one woman. But the European Medicines Agency ruled out the vaccine as a cause. Estonia, Latvia, Lithuania and Luxembourg also have stopped using the batch.
Los Angeles informed residents of a slowdown in the administration of COVID-19 vaccines, blaming a shortage of shots from Johnson & Johnson. The warning comes as people with underlying health conditions become eligible on Monday. The scarcity is a statewide problem, said Gov. Gavin Newsom, who added that he expects a steadier and stronger stream of deliveries by “next month.”
Cancer patients who receive one Pfizer COVID-19 vaccine have little protection against the disease, according to a study in the U.K. After a second shot, however, the patients had the same level of protection as those who are cancer-free. Among 151 people with solid cancers (lung, breast, bowel), 39% were protected three weeks after receiving one Pfizer shot. Among 54 people with blood cancers, just 13% were protected. This compares to a 97% protection rate for those without cancer.
UPDATED: Wednesday, March 10 at 3:14 p.m. ET
Thermo Fisher will pour more than $600 million into capital investment which will help the CDMO meet COVID-19 demand in the short term and more than double production capacity in the long term. Thermo Fisher will add at least 1,500 new employees as part of the expansion. The upgrades, at 11 Thermo Fisher facilities in the Americas, Europe and Asia, will be complete by the end of 2022. Story
The British variant of COVID-19 has been detected in 31 of 39 wastewater treatment plants in Houston, suggesting the more transmissible variant is spreading quickly. The samples are from Feb. 22. When the same tests were done on Feb. 8, the U.K. variant was detected at just 21 of the plants. “It’s actively spreading in our city,” said Houston’s chief medical officer David Persee. The news comes amid Texas relaxing coronavirus safety measures.
UPDATED: Wednesday, March 10 at 10:55 p.m. ET
The United States has agreed to purchase 100 million additional COVID-19 vaccines from Johnson & Johnson. President Joe Biden will announce the deal on Wednesday afternoon, according to media reports, which brings U.S. supply to 800 million doses, more than enough for the U.S. to vaccinate its entire adult population. The U.S. had already locked down enough to do so with last month's deals for 200 million doses from Moderna and Pfizer. Story
Eli Lilly's antibody combination of bamlanivimab and etesevimab reduced hospitalizations and death by 87% in high-risk patients recently diagnosed with COVID-19. The results, from a phase 3 study in 769 patients, showed an improvement on the 70% figure in a previous test of a 2800 mg/2800 mg mixture. The most recent study used a 700 mg bamlanivimab/1400 mg etesevimab blend. Combining both studies, there were 13 COVID-19 related deaths in patients receiving placebo and none in patients who received either antibody concoction. Story
Canadian prime minister Justin Trudeau said Johnson & Johnson has warned of manufacturing problems with the company’s COVID-19 vaccine, which was endorsed for use in the country last week. Canada has ordered 10 million doses of J&J’s single-shot vaccine. More than 5% of the country’s 38 million people have been vaccinated so far. Earlier this week, the European Union got the same warning from J&J.
Pfizer-BioNTech could have the capacity to make 3 billion doses of its two-shot COVID-19 vaccine by next year, according to BioNTech CEO Ugur Sahin. The two companies are scheduled to produce 2 billion doses this year, which includes a contract to provide 500 million doses to the European Union.
VBI Vaccines is launching a phase 1/2 study in Canada of its COVID-19 vaccine, VB-2902. The company also announced a partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop vaccine candidates to combat SARS-CoV-2 variants. CEPI will provide $33 million to advance VBI-2905 specifically against the South African strain. VBI develops enveloped virus-like particle (eVLP) vaccines. The company is based in Massachusetts, with research operations in Canada and a manufacturing site in Israel.
The British variant of COVID-19 is between 30% to 100% more lethal than previous strains, according to researchers. The study compared death rates among those in Britain infected with the variant, known as B.1.1.7, against those infected with other strains. In a group of 54,906 COVID-19 patients, there were 227 deaths among those infected with the variant as opposed to 141 deaths among the same number of patients with other strains. Researchers also discovered that the variant is 40% to 70% more transmissible.
World Trade Organization members opened talks on Wednesday on a joint proposal by South Africa and India to waive intellectual property rights on certain COVID-19 technologies. The International Federation of Pharmaceutical Manufacturers Associations opposes the proposal, contending that supply bottlenecks and the scarcity of raw materials are preventing pharma companies from increasing capacity. In a letter to President Joe Biden, members of PhRMA also urged him to oppose the push.
UPDATED: Tuesday, March 9 at 3:47 p.m. ET
In a letter to President Joe Biden, the Pharmaceutical Research and Manufacturers of America has requested that he oppose a push to suspend critical provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. In October, India and South Africa requested the World Health Organization to suspend TRIPS during the coronavirus pandemic. PhRMA contends that there is no evidence that intellectual property protections are hindering the global response to the pandemic.
The FDA has approved Cue Health’s cartridge-based nasal swab test that can be done completely at home without a prescription. The kit includes a battery-powered cartridge reader that connects to a smartphone app. Results are available in 20 minutes. The company said it expects to be able to produce 100,000 tests per day by the summer. Story
Johnson & Johnson revealed that trials for its COVID-19 vaccine, which was recently approved for use in the United States, had largely been done virtually through IQVIA. The virtual tests began in September. Contract research organizations have been offering siteless trials since the first wave of the pandemic last year. Story
UPDATED: Tuesday, March 9 at 10:14 a.m. ET
How much money will the makers of the three COVID-19 vaccines approved for use in the U.S. make from their shots? Fox Business breaks it down. Pfizer and BioNTech will generate $15 billion in revenues this year from sales of 1.3 billion doses. Moderna expects to supply 1 billion doses in 2021 and 1.4 billion in 2022 for a total haul of $18.4 billion. Johnson & Johnson is on track to supply 1 billion doses of its single-shot vaccine in 2021 for $10 billion in revenue.
The COVID-19 vaccine by AstraZeneca will soon be under review by the FDA. But approval could be complicated by testing data that’s inconclusive. An ongoing phase 3 study in the U.S. and South America could answer many of the questions about the vaccine’s effectiveness in the elderly, which dosing regimen works best and how the shot performs against variants. On Friday, AZ executive Ruud Dobber told CBS News that the company will seek emergency use authorization in the U.S. in “the next few weeks.”
Europe has been beset by supply problems for coronavirus vaccines. Now comes word that the European Union may be facing similar issues from Johnson & Johnson, which has warned the bloc of problems that may impact supply in the second quarter, an EU official told Reuters. The J&J vaccine is expected to be endorsed for use in Europe later this week. The company has agreed to supply the EU with 200 million doses this year. Story
The COVID-19 vaccine from Pfizer-BioNTech is effective against the more infectious Brazilian strain of the virus, according to a lab study. The pharmaceutical companies and the University of Texas took blood samples from people who had received the Pfizer vaccine and put them in contact with an artificially created P1 Brazilian virus. The samples from vaccinated people negated the virus. The variant has surged through Brazil, reinfecting people who previously had the virus. The Pfizer vaccine has also performed well in tests vs. the variants from Great Britain and South Africa. Story
As it deals with a brutal second wave of coronavirus deaths, Brazil is seeking to buy AstraZeneca vaccines from other countries and is pressing Pfizer for early delivery of its vaccine. Studies have shown both vaccines are effective against Brazil’s more infectious P1 strain of the virus. Less than 4% of the country has been inoculated.
Greece and Norway joined a growing list of European countries offering the AstraZeneca COVID-19 vaccine to the elderly. In light of recent studies, Greece reversed a previous ruling restricting use of the AZ shot for those age 65 and older. Norway did the same on Tuesday. Last week, France, Germany, Sweden and Hungary endorsed the AZ shot for the elderly.
UPDATED: Monday, March 8 at 4:04 p.m. ET
While promoting its coronavirus vaccine, Sputnik V, through social media, Russia also has mounted a campaign to undermine confidence in Western COVID-19 vaccines, according to the State Department. Meanwhile, the Sputnik V Twitter account, which reaches the world with cheeky commentary, notched verified status last week. Story
After several missteps in its COVID-19 research efforts, Merck got some positive news in a trial of molnupiravir. The antiviral drug, developed along with Ridgeback, has hit secondary objectives in a new trial, showing a reduction in positive viral culture. Story
CytoDyn’s leronlimab has missed all primary and secondary endpoints in a phase 3 trial of its COVID-19 drug. But by focusing on a subset of severely ill patients on ventilators, CytoDyn found an improved chance of survival and a reduction in the length of hospital stays. Story
UPDATED: Monday, March 8 at 11:04 a.m. ET
Baxter BioPharma Solutions will help manufacture and supply 60 million to 90 million doses of the Moderna COVID-19 vaccine this year from its plant in Bloomington, Ind. The companies announced the agreement on Monday. Baxter will help with the fill-and-finish portion of the manufacturing process.
At least one in five Europeans would refuse the AstraZeneca COVID-19 vaccine, according to an opinion poll by YouGov. Trust in the two other vaccines, from Pfizer and Moderna, is much higher, according to the poll. In Germany, for example, 27% of people said they would turn down the AZ vaccine and wait for another, compared to a 12% refusal rate for the Moderna vaccine and 6% for the Pfizer-BioNTech shot. Last week, several European countries, including France, Hungary and Germany, allowed the elderly to receive the AZ vaccine after initially limiting its use.
Austria has suspended the use of a batch of AstraZeneca COVID-19 vaccine as it investigates the death of one woman and the illness of another. Both were nurses working in a clinic in Zwettl. A 49-year-old nurse died from coagulation disorders. The other, 35, suffered a pulmonary embolism. The vaccine was deemed safe in clinical trials.
Ivermectin, a drug to combat parasitic worms and head lice, should not be used to prevent or treat COVID-19, according to the FDA. Some people have experimented with another form of the drug, commonly given to horses, and have been hospitalized. Misinformation has allowed some unproven COVID-19 treatments to gain traction, including hydroxychloroquine, a malaria drug touted by former President Donald Trump.
Bharat Biotech has begun phase 1 testing of its second COVID-19 vaccine, a single-dose nasal spray. Bharat has already developed Covaxin, a two-shot vaccine that has posted 82% efficacy in a phase 3 trial. Intranasal vaccines have attracted attention because they are easily administered and can be used quickly to cover a large population.
Antibody-drug developer Prestige BioLogics will build a vaccine production center for COVID-19 and other infectious diseases. The construction will begin this month and be complete by the end of the year. “The pandemic is increasing concerns about virus infections in the future while raising expectations about related vaccines,” Prestige CEO Park So-yeon told Korea Biomedical Review.
UPDATED: Friday, March 5 at 3:52 p.m. ET
There's a debate within the Catholic Church over the morality of taking the Johnson & Johnson COVID-19 vaccine. This week, the U.S. Conference of Catholic Bishops said it's "acceptable to receive Covid-19 vaccines that have used cell lines from aborted fetuses" when others aren't available. The USCCB favors the Pfizer and Moderna vaccines, but said that considering the global pain caused by COVID-19, "being vaccinated can be an act of charity that serves the common good." However, one bishop, David Kagan of North Dakota, has prohibited those in his diocese from taking the J&J shot.
Manufacturers of COVID-19 vaccines around the world could soon be feeling the pinch of the United States’ move to lock up raw materials and supplies for Pfizer. The Serum Institute of India, the world’s largest producer of vaccines, and the World Health Organization are warning of supply bottlenecks that could slow production. Story
A Pfizer plant in Kansas has a long history of quality and sanitary issues, but is lined up to manufacture COVID-19 vaccines for the company. The FDA has repeatedly flagged the factory for violations, most recently in January of 2020 when mold and bacteria were discovered in areas that were supposed to be sterile. Pfizer maintains that the problems have been remedied. Story
Wells Fargo will give employees up to eight hours of paid time off to take care of COVID-19 vaccine appointments, the company announced. The bank also will provide free coronavirus testing at its 25 largest hubs, while other employees required to report to the office can request free at home-testing kits.
UPDATED: Friday, March 5 at 11:15 a.m. ET
Pfizer CEO Albert Bourla has postponed a visit to Israel because he and his delegation are not fully immunized against the coronavirus, according to an Israeli TV report. Bourla, 59, has said he would not cut the line for a vaccine. Last week, Israeli prime minister Benjamin Netanyahu announced the Pfizer visit and suggested the possibility of Pfizer building a plant in the country. With elections upcoming, Netanyahu had touted his relationship with the company as key to Israel’s successful vaccination push.
Australia has asked the European Commission to review Italy’s decision to block the export of the AstraZeneca COVID-19 vaccine to its country, a move that was signed off on by the EU because of AZ's failure to meet contracted supplies. While Australian prime minister Scott Morrison requested the review, he also said he could appreciate the decision by Italy where “people are dying at the rate of 300 a day." Italy has had 99,000 COVID-19 deaths compared to 900 for Australia. Meanwhile other European countries are offering various levels of support for Italy's move.
Pakistan will rely solely on free COVID-19 vaccines donated by friendly countries. World relief effort COVAX will deliver 16 million doses of the AstraZeneca vaccine to Pakistan by the end of June. China has already supplied half of a 1 million dose commitment of Sinophram vaccines. Pakistan has administered 275,000 of those doses to health professionals.
Hungary joined the growing list of European countries allowing the elderly to take the AstraZeneca COVID-19 vaccine. The country will permit those older than 60 to get the shot. Hungary has been aggressive in its efforts to vaccinate, accepting shipments of China’s Sinopharm and Russia’s Sputnik V vaccines even though neither have been approved by the European Union.
Germany will allow people 65 and older to receive the AstraZeneca COVID-19 vaccine. It is a reversal in a country that was one of the first in Europe to restrict use of the AZ vaccine among the elderly. But new data has supported the effectiveness of the AZ shot, compelling countries to reconsider.
The AstraZeneca vaccine is effective against the Brazilian coronavirus variant, P1, and will not need to be modified to protect against it, according to a study at Oxford cited by Reuters. Earlier results showed that the AZ vaccine was less effective against the South African variant, which is similar to P1. Brazil is suffering through a brutal second coronavirus wave. On Wednesday, the country recorded its daily record of 1,910 deaths.
Takeda has filed a request with Japan’s health ministry to approve Moderna’s COVID-19 vaccine. Takeda is Moderna’s partner for study, importation and distribution of the vaccine in Japan. The country has already approved and begun administering vaccines from Pfizer and AstraZeneca.
Oxford has closed a trial for colchicine, an anti-inflammatory medicine used to combat gout which had been named as a possible treatment for COVID-19. The study provided no convincing evidence that the drug was effective in hospitalized coronavirus patients.
A day after mayor Mike Duggan said that Detroit was “gonna protect Detroiters with a 95% vaccine,” the city has declined 6,200 doses of the Johnson & Johnson COVID-19 vaccine. A spokesman explained later that Detroit has enough vaccines from Moderna and Pfizer to more than cover all of the upcoming week’s appointments. He added that J&J vaccines would be accepted in the next round and that the city would set up a separate site for J&J vaccinations with patients having the option to decline.
As the world battles the coronavirus pandemic, not only are vaccines a precious commodity, so are syringes. In a typical year, 16 billion syringes are used in the world, with only 5% to 10% used for vaccinations. But the global pandemic has brought the need for 8 to 10 billion syringes alone.
Some people are reporting delayed reactions to Moderna’s COVID-19 vaccine, according to the New York Times. The reactions, roughly a week later, can be confused with an infection and include swelling, itchiness, soreness and discoloration.
UPDATED: Thursday, March 4 at 4:03 p.m. ET
A shipment of AstraZeneca COVID-19 vaccines bound for Australia has been blocked by Italy and the European Union because of the company’s failure to meet contractual commitments with Europe. With AZ requesting to export 250,000 doses of the vaccine from a Catalent plant in Anagni, Italy refused and the EU backed the decision.
A large clinical trial by NIH investigating the effectiveness of two monoclonal antibody treatments for hospitalized COVID-19 patients has been halted. One of the studies was for VIR-7831, from Vir Biotechnology and GlaxoSmithKline. The other was a review of BRII-196 and BRII-198 from Brii Biosciences. Both phase 2/3 trials were closed due to futility. Another trial of BRII-196 and BRI-198 will continue with patients who are not hospitalized.
The Government Accounting Office is working with the FDA to solve its growing backlog of inspections, exacerbated by the coronavirus pandemic. Conducting only inspections deemed “mission critical,” the FDA failed to complete more than 1,000 planned inspections last year. Story
Long-haul coronavirus patients are those who experience lingering symptoms for months. But there is some evidence that these patients improve after receiving vaccines. Information is limited and the data is anecdotal but if the pattern holds, it could help experts discover why symptoms persist in some and could offer a path to relief.
UPDATED: Thursday, March 4 at 10:28 a.m. ET
An enormous international database, funded by Google, launched today to track coronavirus cases. The repository at Global.health is more detailed than Johns Hopkins’ COVID-19 dashboard, collecting 40 variables on subjects, such as the date symptoms first appeared, the date of their first positive test and travel history. The data will help researchers discover how rapidly new variants spread, whether vaccines protect against them and how long immunity to the virus lasts.
Pfizer will send 100 million doses of its COVID-19 vaccine to Brazil as the country battles a severe outbreak. With vaccine supplies stretched thin and a homegrown variant surging, Brazil is posting daily records for coronavirus deaths. Contrary to far-right President Jair Bolsonaro’s lead, São Paolo state has issued a partial lockdown.
CureVac has enlisted the help of Novartis to produce its COVID-19 vaccine. Novartis will manufacture the mRNA and bulk drug product at its site in Austria. Delivery is set to start in the summer of 2021 toward a goal of 50 million doses by the end of this year and an additional 200 million doses in 2022. Other vaccine manufacturing partners CureVac has recruited in Europe include Bayer, Fareva, Wacker and Rentschler. Story
The European Medicines Agency has started a rolling review of the Sputnik V adenovirus COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology. A rolling review allows data to arrive as it becomes available and accelerates the approval process.
Two people with preexisting conditions died within days of receiving the AstraZeneca COVID-19 vaccine, triggering an investigation by the Korea Disease Control and Prevention Agency. A 63-year-old nursing home patient with cerebrovascular disease died Tuesday after developing a fever and then being hospitalized with symptoms of blood poisoning and pneumonia. A man in his 50s with a cardiac disorder died on Wednesday after suffering multiple heart attacks a day after receiving the shot. South Korea has vaccinated more than 85,000 with the AZ shot since kicking off the campaign last week.
Partnerships involving drug companies and private foundations have received little scrutiny during the coronavirus pandemic, the BMJ argues. One example is Wellcome Trust, one of the world’s top funders of health research, which holds investments in companies such as Roche and Novartis, which stand to benefit from those funding efforts. The same potential for conflicts of interest exists with the Gates Foundation, the journal said.
UPDATED: Wednesday, March 3 at 3:52 p.m. ET
Anthony Fauci, the government’s top infectious diseases expert, said that the U.S. will continue as planned to vaccinate Americans with both doses of COVID-19 shots from Pfizer and Moderna. There has been a push to quickly vaccinate as many people as possible with one shot. “We’re telling people (two shots) is what you should do,” Fauci told the Washington Post. He said it would be a "messaging challenge" to change course now.
Developing vaccines was the first major step in combating the coronavirus pandemic. Now comes the next and perhaps more daunting challenge: producing and delivering vaccines to the world. Fierce Pharma breaks down the supply-chain efforts of the five vaccine companies leading the charge. Story
The coronavirus pandemic has been a game-changer for Novavax. Entering last year, the company had $80 million in cash and a “financial operating horizon” of six months, according to its CEO. Fast forward to today and Novavax is a major player on the world stage. By midyear, Novavax expects to have the FDA endorsement of its COVID-19 vaccine and the capacity to produce 2 billion annual doses after building a global network of manufacturing sites and partners in 10 countries. Story
Government funding to the tune of $269 million will help Merck upgrade and leverage two of its manufacturing plants in the United States to produce Johnson & Johnson’s COVID-19 vaccine. Some of the funds were secured by way of the Defense Production Act, which helped the Biden administration facilitate the unusual alliance between the pharma giants. Story
An NIH trial of an experimental COVID-19 antibody treatment from GlaxoSmithKline and Vir Biotechnology has been halted because of concerns over its effectiveness. Other tests for the dual-action monoclonal antibody drug remain active, while the NIH study closes enrollment and lets the “data mature.” Vir shares fell 30% with the news, while GSK’s remained stable. Story
Merck isn’t giving up on its COVID-19 medicine, MK-7100. Last week, it was reported that the FDA asked for more data beyond a phase 3 study. Merck is preparing the drug for another go-round. The company picked up the drug when it acquired Oncolmmune late last year and then signed a $365 million deal to provide it to the U.S. Story
German health minister Jens Spahn said that the country’s health watchdog is set to recommend that the AstraZeneca coronavirus vaccine can be given to people older than 65. Germany’s policy of limiting the AZ vaccine to those aged 18-64 has led to a slow uptake of available doses and unused vials. Early this week, France signed off on the AZ shot for those 65 and older. A recent study in Britain concluded that the AZ vaccine is just as effective as the shot from Pfizer-BioNTech.
Polish biotech Mabion has announced a framework agreement to produce antigen for Novavax’s COVID-19 vaccine. It is an initial step toward a potential manufacturing deal between the two which would make Mabion the first Polish firm engaged in supplying coronavirus vaccines to the world.
UPDATED: Wednesday, March 3 at 12:10 p.m. ET
The Biden administration used the Defense Production Act to broker the manufacturing partnership between Johnson & Johnson and Merck & Co., NPR reports. The unusual deal between the pharma giants had been discussed but the administration applied some “implicit” incentive for them to cooperate, according to the report.
The first round of allocations of the COVID-19 vaccine by COVAX were published. The team will ship 237 million doses of the AstraZeneca shot to 142 middle- and low-income countries by the end of May. The Serum Institute of India is the production partner for AZ. The largest allocations will go to Pakistan (14.6 million doses), Nigeria (13.7 million doses), Indonesia (11.7 million doses), Bangladesh (10.9 million doses) and Brazil (9.1 million doses). COVAX will publish a more detailed breakdown of first-round delivery timelines later this week.
In the largest trial ever conducted in India, Bharat Biotech’s COVID-19 vaccine, Covaxin, has shown 81% interim efficacy. Of 25,800 participants, there were 43 virus cases, seven in participants who had been vaccinated. India had already approved Covaxin in January without the phase 3 data, raising questions about its effectiveness. The country has seen a recent surge in cases.
UPDATED: Tuesday, March 2 at 3:22 p.m. ET
The European Union is showing fractures as some members are going outside the bloc in attempts to secure coronavirus vaccines. Leaders from Austria and Denmark, both critical of the EU’s response to the pandemic, will visit Israel this week to discuss options for future vaccine production and supply. Other countries such as Slovakia and Hungary have turned to Russia and China, respectively, for shots that have not been approved in Europe. Only 5.5% percent of the EU’s population of 447 million have received a first shot. The EU’s Committee for Medicinal Products for Human Use will meet virtually on March 11 to evaluate Johnson & Johnson's COVID-19 vaccine.
Johnson & Johnson will team up with pharma competitor Merck & Co. in an effort to boost production of its COVID-19 vaccine. The Biden administration helped arrange the partnership, according to the Washington Post. Merck will provide two manufacturing facilities in the U.S., one for making the vaccine substance and the other to fill vials. The move gets Merck back into the COVID game after it abandoned two efforts to develop vaccines. Story
The FDA is signing off on coronavirus tests that can be performed or started at home. The two most recently authorized tests are from Quidel and Eurofins. Quidel’s antigen test requires a prescription and can be completed entirely from home. The over-the-counter kit from Eurofins includes a swab and mailing materials, promising a 48-hour turnaround. These are the fourth and fifth at-home tests approved by the FDA since November. Story
An antibody treatment for COVID-19 patients from Cerecor has completed a successful phase 2 trial, showing a 50% reduction in mortality at 28- and 60-day timepoints. Efficacy results were highest in patients older than 60. The small Maryland-based biopharma company will meet with the FDA to discuss a potential path to emergency use authorization. Story
UPDATED: Tuesday, March 2 at 10:51 a.m. ET
A COVID-19 vaccine from Novavax could be available as early as May, according to CEO Stanley Erck, provided that the FDA allows data from a U.K. phase 3 trial that showed the shot had 89% efficacy. Speaking on CNBC, Erck said that the U.K. regulators will likely review the shot in April. A phase 3 trial that includes 30,000 participants in the U.S. is ongoing. Story
The first shipments of AstraZeneca’s COVID-19 vaccines have begun to arrive in low- and middle-income countries through the COVAX worldwide initiative, the drugmaker announced on Tuesday. Working with manufacturing giant Serum Institute of India, AZ sent vaccines to Ghana and Cote D’Ivoire last week, with shipments to follow to Philippines, Mongolia, Indonesia, Fiji and Moldova. The effort will include 142 countries.
In Britain, vaccines from Pfizer-BioNTech and AstraZeneca are “highly effective” in reducing coronavirus infections and severe illness among the elderly, according to Public Health England. For those 80 and older, a single dose of either vaccine reduced hospital stays of three to four weeks by more than 80 percent. After 35 days of receiving the shot, protection from COVID-19 is actually slightly better with the AZ shot.
In France, AstraZeneca’s COVID-19 vaccine will be available to people ages 65-74 who have health issues that make them vulnerable to the virus, said health minister Olivier Veran. Previously the AZ shot was available in France only to those aged 50-64 with health concerns. People ages 75 and older remain eligible for only the Pfizer and Moderna vaccines.
In Canada, the National Advisory Committee has recommended that the recently endorsed AstraZeneca vaccine not be given to those 65 and older, even after Health Canada authorized its use last week for all adults. The committee recommended that the AZ vaccine should instead be provided to essential workers. Health Canada’s chief advisor Supriya Sharma countered that more information is forthcoming that shows the efficacy rate of the AZ shot may actually be higher than those for the Pfizer and Moderna vaccines.
After weeks of steady decline in COVID-19 cases in the U.S., the trend broke last week, fueling concern of a looming variant wave. According to Bernstein analysts, the break is likely overstated because of a backlog in reporting due to the storm in Texas and a reversion to the mean after a shortened holiday week. Perhaps a better trend indicator was that hospital occupancy continued to decline at the same rate, the analysts wrote. The Bernstein team still warns that the threat of a variant wave is real, but can be neutralized by the expected vaccine supply increase this month.
Hydroxychloroquine, the anti-inflammatory drug once touted by former President Donald Trump, should not be used as a preventative measure against the coronavirus and has no real impact on those already infected, said the World Health Organization. The “strong recommendation,” from a WHO expert panel, was based on six trials including 6,000 participants both with and without exposure to COVID-19.
UPDATED: Monday, March 1 at 3:05 p.m. ET
Amid J&J's coronavirus vaccine rollout, the company and health officials are setting out to convince Americans about the shot's value. CEO Alex Gorsky and former FDA commissioner Scott Gottlieb took to the media to explain the value of the J&J vaccine and why efficacy rates of the shot had little chance to measure up to those of Pfizer and Moderna, which were tested under much different circumstances. On CNBC, Gorsky said, “Our data actually includes these most challenging, pernicious, virulent strains and what we saw was an 85% effectiveness rate in the severe disease.” Story
With the goal of delivering 20 million doses by the end of March and 100 million by the end of June, Johnson & Johnson is seeking manufacturing partnerships to increase supply, CEO Alex Gorsky told Bloomberg. J&J’s manufacturing network extends to Europe, Asia and Africa. The company hopes to have eight facilities operating by midyear. “One of our facilities was literally a parking lot 12 months ago,” Gorsky said. “Today it’s one of the most advanced biopharmaceutical vaccine manufacturing facilities in the world. We’re learning along the way.” Story
By cashing in its 7.65% stake in Moderna at an undisclosed point last year, AstraZeneca made approximately $1 billion, the British pharma revealed in its annual report. Over the years, amid several strategic collaborations, AZ had invested more than $290 million in Moderna. When Moderna’s value surged with the development and rollout of its COVID-19 vaccine, AZ was positioned to profit. During the year, Moderna’s share price swelled from just under $20 to $160.