The U.S. expects to distribute 6.4 million doses of Pfizer and BioNTech's shot by mid-December, should the vaccine pass the FDA's bar, Department of Health and Human Services secretary Alex Azar said. Meanwhile, the World Health Organization's vaccine distribution effort, COVAX, has locked down hundreds of millions of AstraZeneca doses.
Shanghai Fosun and BioNTech plan to launch a phase 2 trial of the German mRNA specialist's vaccine hopeful, BNT162b2, in China. Plus, Sinopharm has reportedly filed for official approval to market one or more of its experimental vaccines.
States will have final say over how to distribute the first slate of vaccines, Alex Azar said. Plus, the European Union wants to expedite the process for waiving intellectual property rights to make generic drugs during the pandemic.
The worldwide case count passed 59.9 million Wednesday morning, with more than 1.41 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, Nov. 25 at 9:30 a.m. ET
Pfizer and BioNTech's vaccine candidate could roll out shortly after Dec. 10, Alex Azar said. “We believe we can distribute vaccine to all 64 jurisdictions within 24 hours of FDA authorization," he said, adding that the hope is to kick start vaccinations as soon as shipments arrive. By mid-December, 6.4 million Pfizer doses are expected to go out to states and territories, out of a total 40 million doses slated for delivery this year, General Gustave Perna, who oversees Operation Warp Speed, said. Warp Speed will also run test shipments this week to prepare for its distribution push.
COVAX, the World Health Organization's equitable vaccine distribution scheme, has secured hundreds of millions of AstraZeneca doses, said Gavi, the Vaccine Alliance—co-leader of the initiative. Gavi hailed AZ's recent data reveal as "positive news for the COVAX vision of equitable access." Even more promising, AZ's shot can be shipped and delivered using traditional refrigeration and storage methods, and the company has pledged to supply shots at no profit while the pandemic persists, Seth Berkley, CEO at Gavi, said.
BioNTech and Shanghai Fosun plan to launch a phase 2 trial of the German biotech's vaccine hopeful, BNT162b2, in China, the companies said Wednesday. Testing is slated to take place at Jiangsu Provincial Center for Disease Control and Prevention and will assess safety, plus the shot's ability to provoke an immune response.
Sinopharm filed a request with the National Medical Products Administration to start marketing at least one of its COVID-19 vaccine candidates in China, Xinhua Finance News reports, citing deputy general manager Shi Shengyi. The report did not specify which—or how many—of the drugmaker's two inactivated candidates, both still in late-stage testing, were up for approval. Meanwhile, an anonymous Sinopharm exec told South China Morning Post the Xinhua report was "inaccurate" and the company had yet to file for a marketing nod.
States are on the hook to prioritize who gets the first coronavirus vaccine doses, HHS Secretary Alex Azar said. While a CDC advisory committee plans to meet immediately after an approval to hash out early access, governors will have "final say," which could lead to widely differing distribution schemes across the nation. The CDC's panel, the Advisory Committee on Immunization Practices, on Monday said distribution should aim to tackle health inequities and disproportionate infections, deaths and hospitalizations among Black, Latino and Native American populations.
The European Union wants to accelerate the process for issuing compulsory licenses, which could allow the bloc to bypass intellectual property rights on generic drugs to shore up supply during the pandemic, Reuters reports. The move would serve as a "last resort" and "safety net," an EU document said, essentially giving EU states the ability to manufacture generic meds without drugmakers' consent. Compulsory licensing is allowed by the World Trade Organization as a means to waive normal regulations during an emergency.
Plus, the European Medicines Agency (EMA) thinks it could issue a "positive opinion" on a vaccine before Christmas, Emer Cooke, executive director of the agency, told the Irish news outlet RTE. Cooke on Tuesday said the EMA aims to make an authorization decision around the same time as the U.S. FDA, which plans to review Pfizer's shot in mid-December.
Public health officials and drugmakers should be transparent about unpleasant vaccine side effects to ensure people return for a second dose, doctors said during a meeting with CDC advisors. High fever, body aches, headaches, exhaustion and other symptoms were reported by participants in Moderna and Pfizer's vaccine trials in September. While unpleasant, symptoms usually passed after about a day, participants said. Those side effects are "no walk in the park," but messaging must be clear so that patients aren't deterred from getting a second dose, doctors said.
UPDATED: Tuesday, Nov. 24 at 3:08 p.m. ET
AstraZeneca's late-stage vaccine proved 90% effective in a small group of subjects that received a half-dose primer followed by a full-dose booster—but that was never the plan. "It was a mistake," Mene Pangalos, EVP at the company, told Reuters. The error became apparent when some participants had milder-than-expected side effects, which led researchers to realize they'd "underpredicted the dose of the vaccine by half,” he said. It's unclear how effective the primer-dose regimen truly is. Only 2,741 subjects received the half dose in a more than 30,000-person phase 3. Story
Among more than 74% of Americans who've heard about Pfizer's promising vaccine data, 48% now report a more positive view of the company, The Harris Poll found. Meanwhile, 41% of respondents said they've developed a more favorable view of drugmakers involved in the pandemic vaccine race, while 40% report a sunnier outlook on the industry as a whole. Forty-six percent of people polled also had a more favorable view of the vaccine development process, while 39% adopted a more positive outlook on the approval process. Story
GE Healthcare launched an AI algorithm that can read X-rays to pin down proper placement of ventilator tubes in patients under critical care. As many as one in four patients intubated outside of an emergency room may have a misplaced endotracheal tube, the company estimates, which can lead to severe complications like over-inflating or collapsing of a lung. The algorithm, included in GE's Critical Care Suite, works on the mobile X-ray scanner itself and automatically detects the tube in chest X-ray images, helping flag potential dangers. Story
Two single-domain antibodies, or nanobodies, developed by Twist Bioscience protected coronavirus-infected hamsters from weight loss—a key indicator of disease severity, the biotech said. The weight-loss protection was comparable to results with convalescent plasma in previous clinical studies. Armed with positive hamster data, Twist is now weighing its options, including potentially licensing out the assets for further development, a company spokesperson said. The candidates could be used to develop a preventive daily nasal spray, Twist added. Story
More than 175 U.S. patients with critical COVID-19 respiratory failure and a severe comorbidity have entered into an expanded access protocol (EAP) with NeuroRx and Relief's RLF-100, also known as aviptadil. Of the 90 patients who've so far reached 28 days followup, 72% survived to day 28, the companies said. In a previous comparison between 21 patients given RLF-100 and 24 on standard of care, only 17% of those in the control group survived to day 28, while survival rate with RLF-100 was similar to the 72% figure reported Tuesday, the companies said.
Thirteen African nations are teaming up on a clinical trial to test whether drugs for malaria, HIV, certain cancers and other diseases could prevent moderate COVID-19 cases from becoming more severe, The New York Times reports. The trial will be carried out by ANTICOV, a consortium of 26 African and European clinical institutions. Testing has already kicked off in the Democratic Republic of Congo, with Kenya close behind. Meanwhile, the Equatorial Guinea, Ethiopia, Ghana, Guinea, Kenya, Mali, Mozambique, Sudan and Uganda are waiting on regulatory approval to pitch in.
Reckitt Benckiser’s latest campaign for its over-the-counter cold and flu brand Mucinex encourages patients to "be an ally" to doctors by saying thanks and posting an online review. That support is more important than ever during the pandemic, Claudine Patel, general manager of marketing for RB's North America Consumer Health unit, said. The company has partnered with Healthgrades.com to set up a dedicated page slated to roll out digital ads and social efforts from physician influencers. RB's thinking is backed by data, too: A recent Mucinex and Harris Poll found that 80% of Americans who left online doctor reviews did so to report a positive experience. Story
UPDATED: Tuesday, Nov. 24 at 9:30 a.m. ET
The European Union on Wednesday is expected to approve a deal securing up to 160 million doses of Moderna's vaccine candidate, Ursula von der Leyen, head of the European Commission, said. The bloc in August said it had wrapped preliminary talks with Moderna to lock down 80 million initial doses and an option to purchase 80 million more. Moderna last week revealed its shot was 94.5% effective in phase 3. Story
Plus, Moderna tapped Swedish drugmaker Recipharm to carry out fill and seal packaging on its mRNA-based vaccine candidate. Work will take place at Recipharm's manufacturing unit in Monts, in central France.
Thanks to a rolling EU review, AstraZeneca thinks it could see a "relatively fast approval" for its shot candidate in Europe, Iskra Reic, EVP of the company's Canadian and European operations, told Euronews. Should the vaccine pass the European Medicines Agency's bar, Reic said she was "absolutely convinced" AZ could deploy the shot to all EU member states in roughly the same timeframe. She added the company was still parsing the biology behind Monday's puzzling data reveal and cautioned against the unreliability of cross-trial comparisons.
Médecins Sans Frontières (MSF) called on AstraZeneca to re-commit to its no-profit vaccine pledge and urged the drugmaker to open the books on its licensing and purchase deals so that people and governments could demand a fair price. AZ has said it won't profit off its shot during the pandemic, but terms of a deal disclosed by the Financial Times show the drugmaker can declare the pandemic over as early as next July—well before MSF thinks COVID-19 will be under control. That could open the floodgates for steep shot pricing in 2021's second half, MSF warned.
Meanwhile, Italy is set to receive 16 million AstraZeneca doses in early 2021 through the European Union's supply deal, a government source told Reuters. The country will receive an initial 4 million doses in January, followed by another 12 million between February and April, the source said. Plus, Italy is also in line to receive 3.4 million doses of Pfizer and BioNTech's shot as early as January.
Brazil has collected enough infection data from a phase 3 trial of Sinovac's shot hopeful to potentially unveil interim data in early December, Reuters reports, citing trial organizers from the country's Butantan Institute. The study now has 74 confirmed cases, passing the threshold of 61 infections needed for an interim analysis, Dimas Corvas, the institute's director, said. Brazilian health officials have pegged a possible approval of Sinovac's shot for December or January.
The Nanovaccine Institute at Iowa State University is teaming up with drug delivery device specialist Zeteo Biomedical to develope a next-generation nasal spray vaccine for COVID-19. The single-dose prophylactic, designed for stability at room temperature, could potentially be self-administered using Zeteo's intranasal delivery device. Meanwhile, the university in late October scored $2 million from the Coronavirus Aid, Relief and Economic Security Act to support its development efforts. Story
Russia's Sputnik V vaccine proved 91.4% effective in a second interim analysis from the country's 40,000-person phase 3. The second analysis was carried out after 39 cases were confirmed in the trial—31 in the placebo arm and 8 in the group who received the vaccine. No unexpected health scares were observed, with typical side effects including injection site soreness, fever, fatigue, weakness and headache. Russia plans to unveil further data once 78 infections have been confirmed. Story
And Russia plans to sell Sputnik V for less than $10 per dose internationally and make it free for its own citizens, the Russian Direct Investment Fund said. The country's current deals with foreign drugmakers provide capacity for enough doses for 500 million people per year, starting in 2021, though Russia says it's on the hunt for additional deals to boost supply. Meanwhile, Russia expects to send the first doses out to customers in January.
UPDATED: Monday, Nov. 23 at 3:35 p.m. ET
Moderna will submit its shot for emergency authorization by month's end, with a review slated to take place on Dec. 17, Operation Warp Speed chief Moncef Slaoui told ABC News. Meanwhile, an FDA advisory committee is set to review Pfizer's vaccine data Dec. 10, he said, and some doses could start rolling out the very next day if the shot snares a swift authorization. It remains unclear how long the review process will take. Story
Merck struck a $425 million cash deal to buy OncoImmune and its coronavirus treatment CD24Fc, aimed at the sickest COVID-19 patients. Interim data from a phase 3 trial showed improvements against the virus after a separate study showed gains in stem cell transplant patients earlier this year. Currently Merck has two COVID-19 vaccines in the clinic and an antiviral in phase 2/3 development. Story
AstraZeneca's COVID-19 vaccine candidate can be stored and transported at normal refrigerator temperatures for at least six months, allowing it to be easily administered in a wider variety of healthcare settings—including in low- and middle-income countries. These properties could give the viral-vector shot a logistical leg up over its mRNA-based rivals, which require ultra-cold storage. Story
Following its FDA authorization over the weekend, the federal government will begin distributing Regeneron’s antibody therapy on Tuesday, starting with more than 30,000 courses of treatment, according to a report from Reuters.
The NIH awarded nearly $45 million to expand its efforts aimed at providing access to COVID-19 diagnostics among underserved populations. The federal program added 20 institutions across seven states and territories to its research network, bringing its total funding amount to over $283 million and 55 participating organizations.
A mathematical model by the University of Colorado at Boulder showed that screening half the U.S. population regularly with cheap, rapid COVID-19 tests could help completely eliminate the virus within weeks. Combined with personal quarantines, restaurants and schools would be able to stay open, the researchers said.
UPDATED: Monday, Nov. 23 at 9:15 a.m. ET
On average, two separate regimens of AstraZeneca's vaccine candidate proved 70% effective in late-stage trials, the drugmaker said. Most subjects—8,895, to be exact—received two full doses of the shot, which boasted 62% efficacy in that group. Meanwhile, a smaller cohort of 2,741 subjects got a half-dose for their first shot, followed by a booster; efficacy was 90% in that arm. Nobody who received the shot was hospitalized or had a severe case of COVID-19 and no serious side effects linked to the vaccine have been confirmed, AZ said. Story
AstraZeneca should have enough of its candidate vaccine to produce 200 million doses by year-end, with enough drug substance to crank out 700 million doses globally by the end of 2021's first quarter, operations exec Pam Cheng said Monday. The drugmaker will keep the "active" drug substance in stock as it awaits approval worldwide, she added. The company aims to provide the U.K. with about 4 million finished doses this year, followed by an estimated 40 million doses in Q1, though AZ could double that supply if it proceeds with an initial half-dose, Cheng said.
Regeneron's antibody cocktail bagged an emergency nod from the FDA Saturday to treat mild- to-moderate, non-hospitalized patients at high risk for progressing to severe COVID-19. The therapy—a combination of the monoclonal antibodies casirivimab and imdevimab—was shown to reduce viral load significantly better than placebo in a phase 1/2 trial and, more importantly, lowered the risk of hospitalization within 28 days. Regeneron aims to make the treatment available for around 80,000 patients this month and 300,000 patients by the end of January. Story
Pfizer and BioNTech's vaccine hopeful could win U.K. authorization in as little as a week—ahead of U.S. clearance, government sources told The Telegraph. British regulators are about to start their assessment of the shot, and the country's National Health Service has been told to prepare to start administering the vaccine by Dec. 1. Pfizer has pledged to provide 10 million doses to the U.K. this year out of a total 40 million-dose order.
India's Bharat Biotech expects its vaccine hopeful, Covaxin, to boast at least 60% efficacy, Sai Prasad, president of quality operations at the company, said. Bharat kicked off phase 3 trials on Nov. 20 and plans to launch its shot in 2021's second quarter. Covaxin is being developed in collaboration with the Indian Council of Medical Research's National Institute of Virology.
UPDATED: Friday, Nov. 20 at 3:05 p.m. ET
Novartis pitched in $50 million upfront to snare a global license to develop and market Mesoblast's cell therapy remestemcel-L in COVID-19. The FDA last month rejected Mesoblast's filing for the treatment in children with steroid-resistant graft-versus-host disease, though the company in May had already kicked off a phase 3 trial to see whether its cell therapy could help COVID patients with acute respiratory distress syndrome. Novartis, which already boasts an approved cell therapy, will also help scale up commercial manufacturing to meet pandemic demand. Story
Cue Health's rapid, point-of-care coronavirus diagnostic test will be shipped out to Alaska, Florida, Louisiana, New Jersey and Texas in a government pilot program under the Department of Health and Human Services. The molecular test, which uses nasal swabs and a cartridge-based reader that sends results to a connected smartphone, won FDA authorization in June, and should tee up diagnoses in healthcare settings with larger groups of people at high risk for COVID-19, like nursing homes and long-term care centers. Story
A pre-engineered version of Adagio's experimental antibody, ADG20, protected against SARS-CoV and SARS-CoV-2—the virus that causes COVID-19—in mice, the company reported on the preprint site bioRxiv. In lab tests, the drug was also able to neutralize two related coronaviruses circulating in bats—potentially giving it an edge over other antibodies in the works, which tend to trade breadth of activity in multiple viruses for potency against SARS-CoV-2 specifically, said Laura Walker, Ph.D., chief scientists at Adagio. Story
Serum Institute of India, which has already produced millions of doses of AstraZeneca's vaccine candidate, will seek emergency approval in-country as soon as regulators in the U.K. clear the shot for use among the general public, CEO Adar Poonawaala said. The company is almost on "autopilot" as it awaits vaccine results; SII can then start cranking out "hundreds of millions" more doses, Poonawalla said.
The United States, the European Union and several other wealthy nations on Friday pushed back on a proposal to waive certain intellectual property rights for COVID-19 drugs and vaccines, Reuters reports, citing three trade sources. That lack of support means the proposal will likely fail when it goes before the World Trade Organization next month. The waiver has been backed by a slate of developing countries, China, the World Health Organization and Médecins Sans Frontières.
Hungary's plans to test and potentially produce Russia's controversial Sputnik V vaccine could strain its relationship with the European Union and undermine public confidence in a vaccine, the European Commission said. The vaccine must be authorized by the European Medicines Agency before it can go out to EU states, though the regulator says it has yet to receive any data from Russia. Meanwhile, Hungary on Thursday imported its first doses of Sputnik V, which it will study to "make a well-founded decision on potential usability and approval," the country's foreign minister said.
UPDATED: Friday, Nov. 20 at 9:29 a.m. ET
Eli Lilly and Incyte's rheumatoid arthritis med Olumiant, in tandem with Gilead's Veklury (remdesivir), won an emergency nod from the FDA to treat hospitalized COVID patients requiring oxygen support, mechanical ventilation or extracorporeal membrane oxygenation. An NIAID trial of the drug showed patients on the combo had a median recovery time of seven days, compared to the placebo and Veklury arm's eight days. Patients on the combo were also less likely to die or need mechanical ventilation after 29 days and had better odds of improvement at day 15 versus the control group. Story
Meanwhile, a World Health Organization panel on Thursday advised against the use of Gilead's Veklury to treat COVID-19. The panel's guidance, published in the journal BMJ, "concluded that the evidence did not prove that remdesivir has no benefit; rather, there is no evidence based on currently available data that it does improve patient-important outcomes." Gilead, for its part, told The Wall Street Journal it was "disappointed" that the WHO's Veklury guidelines came at a time when cases are mounting worldwide. Story
The European Union has agreed to pay €15.50 ($18.34) per dose for Pfizer and BioNTech's vaccine candidate, Reuters reports, citing an EU official close to the matter. That would put the EU on the hook to pay up to €3.1 billion ($3.7 billion) for its 200 million-dose order, rising to €4.65 billion ($5.51 billion) if the bloc chooses to purchase another 100 million doses. Separately, the EU confirmed it would pay €10 ($11.84) per dose for CureVac's mRNA-based vaccine, for an initial supply of 225 million doses. The block this week secured up to 405 million doses of CureVac's shot hopeful.
Roche is poised to start delivering Regeneron's two-antibody cocktail in 2021's first quarter, CEO Severin Schwan told Bloomberg. An emergency nod for Regeneron's antibody cocktail could be granted "very soon," though initial demand is sure to outstrip supply, Schwan said. The companies will have a combined capacity of roughly 2 million doses next year. Meanwhile, Roche is working to ramp up production as fast as possible, Schwan added.
Sinovac could have phase 3 data on its vaccine hopeful, CoronaVac, by next month, Weining Meng, senior director of the Chinese biotech, said Friday. The shot is in late-stage testing in Brazil, Indonesia and Turkey. Sinovac earlier this week published early- to mid-stage data showing CoronaVac sparked a swift immune response but lower antibody levels than those seen in patients who've recovered from COVID-19.
ApiJect Systems on Thursday was approved by the U.S. government for a $590 million loan to produce single-dose injectors for COVID-19 vaccine candidates. ApiJect's self-contained device has yet to pass the FDA's bar, prompting health experts to question the government's loan. The company, meanwhile, plans to build a facility with capacity for 3 billion pre-filled injectors annually. The facility would be able to support candidates that require standard cold storage or ultra-cold storage up to -94 degrees Fahrenheit—the temperature required for Pfizer's vaccine. Story
UPDATED: Thursday, Nov. 19 at 3:20 p.m. ET
Pfizer and its German partner BioNTech plan to file for an emergency use authorization for their shot in the U.S. Friday, BioNTech CEO Uğur Şahin told CNN. Depending on the speed of the review process, the partners' vaccine could snare authorization or conditional approval in 2020, with distribution efforts kicking off before year-end, Şahin said. Pfizer on Wednesday announced its vaccine had shown 95% efficacy in phase 3.
Meanwhile, BioNTech is working on a new formulation for its shot that could enable shipping at room temperature, Şahin said during his CNN interview. The development process is happening "in parallel" with Pfizer and BioNTech's current efforts and could bear fruit as early as the second half of 2021, he said. Concerns have mounted over storage and shipping requirements for the partners' candidate, which must be kept at -94 degrees Fahrenheit—far colder than than the requirement for most vaccines.
And Pfizer aims to start distributing its vaccine "within hours" of scoring an emergency nod, starting with shipments wherever the shot is cleared first, CEO Albert Bourla told Sky News. This could spark a "race to regulate" as authorities hustle to review data and lock down doses for their countries, he added. If one regulator OKs the shot before another, the "ethical" move would be to start sending doses to people in that jurisdiction, though patience is crucial, since demand will outpace supply early in the vaccination process, Bourla said. Story
AstraZeneca's vaccine could launch with little lag behind Pfizer and Moderna's candidates, currently at the head of the pack, Andrew Pollard, head of the University of Oxford's vaccine trial, said. Still, he emphasized that AZ and Oxford aren't rushing, nor are they competing with other developers. Phase 3 data is expected before Christmas, at which point it will be sent off to regulators. If that process moves at a pandemic-appropriate pace, "it's possible that things could line up so there is not very much difference in timing between the various different vaccines,” Pollard said.
Siemens Healthineers developed a quantitative test that measures the antibodies able to neutralize coronavirus. The IgG antibody test—a new version of the serology test Siemens launched over the summer, which estimates the numbers of coronavirus antibodies in a person’s bloodstream—boasts a CE mark in Europe and is under review for emergency use at the FDA. The test should help gauge the level of immunity conferred by a vaccine, and the company plans to make it available internationally via its Atellica, Advia Centaur and Dimension laboratory hardware. Story
The Department of Health and Human Services (HHS) put the kibosh on a $15 million contract that would have helped secure celebrities to feature in the agency's controversial $250 million ad campaign to "defeat despair and inspire hope" amid the pandemic. While Hollywood will no longer make an appearance, HHS is pressing on with a new, "science-based" approach to its campaign. Story
Médecins Sans Frontières (MSF), also known as Doctors Without Borders, has called for governments to support a request to waive certain intellectual property rights on COVID-19 drugs and vaccines during the pandemic, slated for consideration at an upcoming World Trade Organization meeting. Kenya, Eswatini, India and South Africa are co-sponsoring the waiver, which so far has the support of 99 countries. “All COVID-19 health tools and technologies should be true global public goods," Sidney Wong, executive co-director of MSF's Access Campaign, said.
UPDATED: Thursday, Nov. 19 at 9:30 a.m. ET
In late October, AstraZeneca teased phase 2 data showing its vaccine spurred an immune response in patients both young and old. Now, those results have been peer reviewed and published in The Lancet. Healthy adults over the age of 56 showed a similar immune response to that of younger patients, and the oldest participants, whose median age was between 73 and 74, experienced milder side effects than the younger cohort. AZ's phase 2 enrolled 560 adults, 240 of whom were over the age of 70. Story
If Pfizer's shot wins an emergency nod, vulnerable groups—most likely healthcare workers, first responders and elderly Americans living in nursing homes—could start receiving the vaccine in December, HHS secretary Alex Azar said Tuesday. By January, there should be enough Pfizer doses for everyone in that initial group and by March or early April, Azar expects to have enough vaccines from Pfizer and other developers for all Americans.
Roche's arthritis med Actemra, also known as tocilizumab, hit a "key efficacy endpoint" among seriously ill COVID-19 patients. It's unclear if the drug helped people stay alive or shortened the time on intensive care support like mechanical ventilation, though more details should be published in a matter of weeks, Anthony Gordon, lead investigator of the 303-patient trial, said.
Later today, the U.S. International Development Finance Corp (DFC) will likely reveal that it's extended its $590 million loan to ApiJect—maker of an unproven injection device still awaiting FDA clearance, NPR reports. The single-use device is meant to offer an alternative to vials and syringes, supplies that could become strained as shots start to roll out. Having a backup plan for glass vials is important, but the fact that the government has invested so much in a technology that has yet to go through the FDA is cause for concern, one health expert told the news outlet.
Close to 1 million people have received Sinopharm's experimental COVID-19 vaccine, the Chinese drugmaker said Wednesday. Since July, the country has allowed essential workers and other limited groups to take three separate vaccine candidates—two from Sinopharm and one from Sinovac—none of which have completed phase 3 testing. No serious side effects have been reported by those receiving the experimental shot in emergency use, Liu Jingzhen, chairman of Sinopharm, said, though it's unclear which vaccine he was referring to.
The concept of "herd immunity" comes with some big caveats, health experts told Reuters. It would not imply individual protection from the virus, since the thrust of the idea is to protect the vulnerable. Meanwhile, we still don't know how fast the virus spreads under normal circumstances, without travel and social restrictions in place, Winfried Pickl, professor of immunology at the Medical University of Vienna, said. Finally, while the first vaccines poised to hit the market will likely prevent individual COVID-19 cases, they may not stop the spread of the virus to unvaccinated individuals.
UPDATED: Wednesday, Nov. 18 at 2:50 p.m. ET
The FDA approved Lucira Health's all-in-one COVID-19 diagnostic, which people over the age of 14 can use at home with a prescription. The kit—which relies on a swab and aims to deliver results in about 30 minutes—shrinks a molecular test for the virus' genetic code down to a handheld unit, complete with all the necessary chemical reagents. The company expects the test to become available nationwide early next spring with a price tag of $50. Story
AstraZeneca and the University of Oxford have enlisted research services firm CCT Research to help recruit 1,500 patients for a vaccine trial in Arizona. CCT works as a clinical site network, embedding research studies within local communities. The Arizona trial, slated to run at Bayless Integrated Healthcare's site in downtown Phoenix, will compare AZ's shot hopeful against placebo in healthy patients over the age of 18. Story
Johnson & Johnson over the next five years will invest $100 million to help address racial inequities in healthcare, drawn into sharp focus against the backdrop of COVID-19. J&J's efforts are threefold: work with local communities; expand and add partnerships; and increase internal efforts to hire and promote people of color to the management level and above. In one snapshot of the drugmaker's community outreach efforts, J&J plans to grow its support of mobile health clinics—already delivering COVID-19 testing and information on clinical trial inclusivity—for communities of color. Story
With cases mounting in the U.S., drug and vaccine trials are receiving an unexpected tailwind, The New York Times reports. Moderna, which announced positive early results on its shot hopeful Monday, had originally aimed to submit data to experts after observing 53 COVID-19 cases in its phase 3 trial, but higher infection rates allowed the biotech to base its readout on 96 sick subjects. Enrollment in Regeneron's antibody cocktail trial has also hastened this month, a company spokeswoman told the news outlet.
In late October, 58% of Americans said they would get a COVID-19 vaccine—up eight points from a low of 50% in September, a new Gallup poll found. Meanwhile, 42% of the 2,985 American adults surveyed said they definitely wouldn't get a vaccine, down slightly from 50% in September. Thirty-seven percent from that group cited rushed vaccine development as the main cause for concern, while another 26% said they wanted to wait for confirmation that an approved shot is safe.
Hummingbird Bioscience could roll out its experimental antibody in Singapore and other countries by early 2021, Jerome Boyd-Kirkup, co-founder of the company, told CNBC. Small-scale trials of the treatment, dubbed Hummingbird 115, kicked off in Singapore last month, with phase 3 studies expected to start in December. “We’re aiming for early 2021 for widespread accessibility of this therapy to patients,” Boyd-Kirkup said.
UPDATED: Wednesday, Nov. 18 at 9:25 a.m. ET
Pfizer has obtained the necessary follow-up safety data to pursue an emergency nod for its shot, CEO Albert Bourla , Ph.D., said. The company on Wednesday published detailed data from its phase 3, which showed its mRNA-based vaccine was 95% effective. In the control group, 162 patients developed COVID-19, compared to eight subjects in the vaccine arm. Nine severe cases were observed in the placebo group, versus the vaccine cohort's one. Story
Roche successfully tested its ability to churn out large quantities of Regeneron's experimental antibody cocktail and is ready to kick off manufacturing should the treatment snare approval, George Yancopoulos, Regeneron's chief scientific officer, told Reuters. The Swiss drugmaker could start producing the treatment in 2021's first quarter, a Roche spokesperson added. Regeneron is on deck to provide 300,000 doses of its treatment to the U.S. as early as January, with 50,000 doses already stockpiled.
Sinovac's experimental vaccine can induce an antibody response within four weeks of immunization by giving two doses of the shot at a 14-day interval, the Chinese biotech said in a publication of its phase 1/2 trial in the journal Lancet Infectious Diseases. Sinovac's early- and mid-stage tests took place in April and May. The biotech is now plowing ahead with late-stage trials, although one phase 3 study was stopped in Brazil this month after reports of a serious safety scare. Story
Meanwhile, Brazil's Sao Paulo state will start importing an initial 46 million doses of Sinovac's shot this week, which could be made available in January if the vaccine passes muster with local regulators, the director of the state’s Butantan Institute biomedical center said. Butantan, which is organizing phase 3 trials of the shot in-country, said last week's pause was unrelated to the vaccine. Meanwhile, Brazil said it would also look to purchase Pfizer's vaccine if the shot is proven effective and registered with the country's health authority, Anvisa.
With lives at stake, the Trump Administration needs to share critical COVID-19 data with President-elect Joe Biden's team, including information on the supply of therapeutics, testing materials, personal protective equipment, ventilators, hospital bed capacity and workforce availability, the American Medical Association, the American Nurses Association and the American Hospitals Association said. Leaders from the trio of healthcare juggernauts signed a letter making their position known a day after Biden warned that more people would die if Trump failed to concede.
It will likely take weeks to determine whether a potential vaccine is worthy of an emergency nod, Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, told Business Insider. Marks added that the FDA will make the process "very open" and said he hopes the extra review time will help boost faith in a final product. "Everything that we are trying to do here, this is all about ensuring the public re-develops the kind of trust they once had in vaccines." Story
Celltrion will likely pursue an emergency nod for its monoclonal antibody, CT-P59, in South Korea before year-end, group chairman Seo Jung-jin said. The company is currently "wrapping up" a phase 2 trial of the drug, he added. Earlier this year, the company announced that its antibody could shorten patients' recovery time with no reported side effects, adding that the drug could neutralize the virus within four to five days, potentially protecting patients with mild symptoms from developing severe disease.
A scant 15% of airlines feel prepared to transport Pfizer's vaccine hopeful at the required, ultra-cold temperature of -94 degrees Fahrenheit, a recent survey by an air cargo association and drug shipper's group found. Around 60% said they'd be able to transport Moderna's shot candidate, which must be kept at -4 F. Meanwhile, as airlines scramble to lock down specialized shipping containers, cold storage specialists like Cryoport and Germany's va-Q-tec have seen shares soar, Reuters reports. Story
UPDATED: Tuesday, Nov. 17 at 3:16 p.m.
The U.K. hastily secured 5 million doses of Moderna's vaccine candidate Monday, hours after the biotech unveiled positive phase 3 data on its mRNA-based shot, health secretary Matt Hancock said. The U.K. chose not to purchase Moderna's vaccine earlier this year over concerns about vaccine nationalism and Moderna's then-lack of a dependable European supply chain, The Guardian reported, citing sources close to the matter. Moderna has since signed on manufacturing partners in Switzerland and Spain.
The FDA postponed its decision on Bristol Myers Squibb's CAR-T hopeful liso-cel—picked up in its $74 billion Celgene buyout—thanks to COVID-19 restrictions that kept the regulator from inspecting a Lonza facility in Texas, slated to help churn out viral vectors for the cell therapy. The FDA did not provide a new anticipated action date, BMS said, dimming hopes of a liso-cel approval before year-end. Story
Infectious disease experts now expect a COVID-19 vaccine by May 2021—a month sooner than previously predicted—but that slightly sped-up timeline is joined by growing reluctance to give an authorized shot to patients, a new survey by InCrowd showed. Just 47% of U.S. infectious disease experts said they would feel "highly confident" in prescribing an FDA approved vaccine, InCrowd's October survey found. Respondents further predicted that 40% of patients would also be wary of getting the vaccine.
Ohio Republican Sen. Rob Portman will roll up his sleeve to take part in Johnson & Johnson's phase 3 vaccine trial. He hopes the move will encourage others to enroll in ongoing U.S. shot studies and reassure the public about the safety and efficacy of vaccines once they've moved through clinical trials and the FDA.
New Jersey-based CDMO Cambrex is plugging $50 million into four additional active pharmaceutical ingredient (API) facilities at its Charles City, Iowa, small-molecule drug site. The investment is set to boost capacity by 30% and meshes with the CDMO's goal to offer stateside API production to drugmakers looking for a "reliable" supply chain. U.S. lawmakers have called for more investment in domestic drug production this year as the pandemic puts pressure on an increasingly global pharmaceutical supply chain. Story
China's plan to vaccinate the public with unproven shots may be working too well, The New York Times reports. Five-hundred doses sent to the city of Yiwu were snapped up in a matter of hours. Other cities are limiting doses and asking people to prove they are traveling to qualify. Meanwhile, scalpers are charging as much as $1,500 for vaccine appointments, the news outlet wrote. And while China says it's monitoring vaccinated patients, a consent form for one candidate reviewed by the Times made no mention of the fact that the product was still in testing.
UPDATED: Tuesday, Nov. 17 at 9:13 a.m.
Pfizer kicked off a pilot delivery program for its vaccine in Rhode Island, Texas, New Mexico and Tennessee, selecting the states for their differences in size, diversity, vaccine infrastructure and patient populations split between rural and urban areas, Reuters reports. Pfizer's BioNTech-partnered shot must be stored and shipped at -94 degrees Fahrenheit, fueling recent concerns about widespread storage and distribution.
Germany's CureVac is ramping up manufacturing to produce "pandemic scale" volumes of its vaccine candidate, CVnCoV, the drugmaker said in a release. The company plans to build an integrated European manufacturing network, leveraging CDMOs for each step of the production process. CureVac aims to boost vaccine capacity to upward of 300 million doses in 2021 and up to 600 million doses by 2022. It's also working on an additional, large-scale production facility at its headquarters in Tübingen, Germany. Story
Samsung Biologics is mass producing Eli Lilly's recently authorized monoclonal antibody, bamlanivimab, the South Korean drugmaker said Tuesday. Samsung in May entered a production deal with Lilly and said it has a long-term contract with the antibody developer, but didn't share further details. Lilly is gunning to produce 1 million doses of its antibody by year-end and expects supply to increase in 2021 as more manufacturing resources go live. Story
Meanwhile, U.S. hospitals are already facing high demand and tight supplies of Lilly's antibody, Reuters reports. At $1,250 per dose, the U.S. has so far bought 300,000 doses of bamlanivimab—enough for about a week's worth of new infections at the current rate, health experts said. Doctors also called for "more conservative criteria" on who should be eligible for the treatment; under the current label, the drug is OK'd to treat older patients recently diagnosed with mild to moderate disease, as well as those with risk factors like obesity and diabetes.
India's Bharat Biotech launched a 26,000-person phase 3 trial of its vaccine candidate, Covaxin, developed with the Indian Council of Medical Research. Volunteers will receive two injections of either vaccine or placebo 28 days apart, and Bharat plans to monitor patients over the next year to screen for incidences of COVID-19. The trial is both India's "first phase 3 efficacy study for a COVID-19 vaccine" and the largest late-stage efficacy trial ever conducted in the country, Bharat said in a statement.
The Indian government is in talks with Moderna after the Massachusetts-based biotech unveiled strong data on its mRNA-based vaccine hopeful Monday, the Hindustan Times reports. The country is also holding discussions with domestic vaccine makers like Serum Institute of India, Bharat and Zydus Cadila, along with Pfizer, for potential shot doses, the news outlet reported, citing a senior government official.
UPDATED: Monday, Nov. 16 at 3:07 p.m.
After several months of discussion, the European Union has agreed to purchase up to 405 million shot doses from German vaccine maker CureVac, European Commission President Ursula von der Leyen said. The commission will authorize the deal on Tuesday and expects a signature to come sometime this week, she added. If the shot passes muster in the clinic, the EU would receive 225 million initial doses, with the option to later purchase another 180 million. CureVac in September snared $299 million in German funding for its vaccine work. Story
Former FDA commissioner and Pfizer board member Scott Gottlieb suggested the entry of two "highly effective" vaccines into the market—namely Pfizer's and Moderna's—"could effectively end this pandemic in 2021," CNBC reports. Gottlieb's prediction hinges on the efficacy of those mRNA-based shots once full data are released, combined with the fact that many people will have already had COVID-19 by 2021.
But even with mRNA vaccines from Pfizer and Moderna posting strong data in rapid succession, it's essential that people not become complacent about the virus, the World Health Organization warned Monday. The agency is concerned about mounting case numbers—particularly in Europe and the U.S.—as health workers and healthcare systems in those regions are "pushed to the breaking point," WHO Director-General Tedros Adhanom Ghebreyesus said via Twitter.
States, cities and hospitals across the U.S. are vying for ultra-cold freezers as Pfizer's vaccine rollout looms, Reuters reports. The CDC in August told healthcare providers not to invest in specialty freezers for the shot—which must be stored at -94 degrees Fahrenheit—as it works on its own solution. Meanwhile, states like California, Rhode Island and New Mexico told the CDC they anticipate challenges due to limited freezer supplies, while around half a dozen states said they're looking to secure their own units.
New York, California, Connecticut, West Virginia and the District of Columbia have established committees to vet a potential COVID-19 vaccine once it passes the FDA's bar, while Washington, Oregon and Nevada are each adding a representative to California's panel. The effort, primarily in Democratic-led states, follows mounting vaccine skepticism and concerns that the Trump Administration has prioritized speed above all else in the race for a vaccine. Some health experts, like HHS' deputy chief of staff for policy, Paul Mango, fear those states' reviews could undermine the FDA.
Meanwhile, social media has become a battleground for vaccine misinformation, fueling skepticism that could prevent the U.S. from controlling the virus' spread once a shot is approved, Richard A. Stein, M.D., Ph.D., an adjunct professor at the NYU Tandon School of Engineering and senior editor with the International Journal of Clinical Practice, told Yahoo Finance. Facebook, for its part, has started placing links to the CDC's website on the pages of certain groups circulating false information, while YouTube has started demonetizing anti-vaccine content.
UPDATED: Monday, Nov. 16 at 9:30 a.m. ET
Moderna's mRNA-based vaccine candidate boasted nearly 95% efficacy in the first interim analysis of the drugmaker's phase 3 data. The review covered 95 confirmed cases from the study—90 from the placebo arm and five cases from the group that received the shot, dubbed mRNA-1273. The company submitted data on 11 severe cases of COVID-19, all recorded in the control group. No significant side effects were observed, and Moderna said it would use the data to file for an emergency nod "in the coming weeks." Story
Moderna's shot should remain stable at 36 degrees Fahrenheit to 46 degrees Fahrenheit—about as cold as your standard fridge—for 30 days, new stability testing unveiled by the company shows. Moderna had earlier estimated its vaccine could remain at those temperatures for around a week. Meanwhile, the shot could be kept for up to six months when stored at -4 F, or standard freezer temp. Once removed for administration, the shot can remain at room temperature for up to 12 hours, Moderna said. Story
The European Commission hailed Moderna's "encouraging" vaccine results. The bloc is inking a supply deal with Pfizer and BioNTech later this week, with "more to come soon," EU health commissioner Stella Kyriakides said.
Johnson & Johnson on Monday kicked off a phase 3 trial assessing a two-dose regimen of its vaccine hopeful. The company aims to enroll up to 30,000 subjects; 6,000 are expected to be recruited in the U.K., along with subjects from countries with high case counts, including Germany, Belgium, Spain, the Philippines and the U.S. Participants will receive a second dose of vaccine or placebo 57 days after their first doses, J&J said, with the aim to test whether an additional shot will help protect against the disease for longer. Story
Strong data on Pfizer's shot candidate could convince more people to get vaccinated, NIAID director Anthony Fauci, M.D., told Bloomberg. “What I would hope is that even though there’s a degree of skepticism about vaccines in general, that when the general public sees how effective this vaccine is, we might see a turnaround of the attitude toward vaccination,” he said. Last week, Pfizer announced its shot had so far shown more than 90% efficacy in phase 3.
President-elect Joe Biden's coronavirus team plans to meet with major vaccine makers this week, including Pfizer, Biden's newly elected chief of staff, Ron Klain, said. President Donald Trump's failure to concede the election has hindered the transition of power, keeping Biden's top health officials from working with the government, Klain said. Manufacturing and distribution will pose a significant early challenge to Biden's team. To that end, it's crucial the transition team meet with the HHS "as quickly as possible," Klain added.
Come spring, Russia aims to mainly produce a freeze-dried version of its vaccine, Sputnik V, in a bid to eliminate ultra-cold shipping requirements, Reuters reports. Currently, Russia's shot must be kept at -18 degrees Celsius, or -0.4 degrees Fahrenheit, but the country is working on a lyophilized, powdered version that should remain stable at 35.6 F to 46.4 F. Russia plans to mainly produce that version starting in February, the head of the country's sovereign wealth fund said.
UPDATED: Friday, Nov. 13 at 3:32 p.m. ET
Operation Warp Speed is seeking White House approval to connect with President-elect Joe Biden's transition team, Moncef Slaoui told the Financial Times. Slaoui, a GlaxoSmithKline vet who heads up the government program, said he wants to make sure the effort remains on track, no matter the administration in charge, and he needs a green light from President Donald Trump's team to reach out to Biden's. Trump so far has refused to concede the election, complicating the transition of power.
Qiagen kicked off marketing and distribution of its QIAreach antigen test in the U.S., where the portable diagnostic is under FDA review for emergency lab use. The company hopes to amend the authorization before year-end to enable use in hospitals and other point-of-care settings, and it's pursuing an in vitro diagnostic CE mark in Europe. QIAreach uses a digital hub and interchangeable test-stick cartridges to process more than 30 samples per hour. Story
The European Society of Intensive Care Medicine says Gilead's remdesivir, now known as Veklury, should not be used in COVID-19 patients requiring critical care, the group's president, Jozef Kesecioglu, told Reuters. The European medical association and the U.S. Society of Critical Care Medicine will state the recommendation in an upcoming paper on COVID-19 meds, Kesecioglu added. The advice follows a large WHO study that found the antiviral did little to help hospitalized patients. Gilead, for its part, has contested those results. Story
Patients taking the popular over-the-counter sleep aid melatonin were 28% less likely to test positive for COVID-19, a new study from the Cleveland Clinic found—though more testing is needed before the supplement could be widely used in treatment, the study's senior author said. Researchers used an AI tool to screen data from 26,779 people in the clinic's COVID-19 registry, of whom 8,274 tested positive. Story
The antidepressant fluvoxamine, if taken within the first week of COVID-19 symptoms, could reduce the risk of breathing problems and hospitalization in patients with mild disease, a study from the Washington University School of Medicine in St. Louis found. The COVID-19 Early Treatment Fund will provide additional funding to the university for an 880-person trial to confirm the results.
Among those benefiting from Pfizer's strong vaccine results this week? German brothers Andreas and Thomas Struengmann—founders of the generic drugmaker Hexal, bought by Novartis in 2005. The pair have collectively grown about $8 billion richer this year thanks to their stake in Pfizer's German mRNA partner, BioNTech, BNN Bloomberg reports. Back in 2008, the brothers helped to give BioNTech €150 million in startup funds. They now own around half of the company.
In recent months, state hackers from Russia and North Korea have targeted "seven prominent companies directly involved in researching vaccines and treatments for COVID-19" in Canada, France, India, South Korea and the U.S., said Tom Burt, Microsoft VP of customer security and trust.
Tesla's Elon Musk may have COVID-19, but he wouldn't know it from the tests he's taken. Musk was tested four times Thursday, all with the same BD rapid antigen test, receiving two positive and two negative results, he alleged on Twitter. "Something extremely bogus is going on," he said. Musk's view on the pandemic has been divisive—he later tweeted that the daily testing rate has gone "ballistic" in the U.S. and implied mounting case numbers were due to false positives.
The U.S. recorded more than 160,000 new cases Thursday, a little more than a week after logging 100,000 new infections in a single day for the first time, The New York Times reports. Meanwhile, COVID-19 hospitalizations reached 67,096 Thursday, setting a record for the third straight day, the news outlet said.
The U.S. has an undeniable "independent spirit," but it's time for the public to start following the rules when it comes to preventing the coronavirus' spread, NIAID director Anthony Fauci said. Speaking with other health experts at Washington National Cathedral Thursday, Fauci acknowledged that it's difficult to compare the U.S.' coronavirus response to other nations, given the country's size, but argued that stricter adherence to public safety guidelines would likely prevent another lockdown.
UPDATED: Friday, Nov. 13 at 9:56 a.m. ET
A vaccine ought to be required once one is proven safe and effective, Roche Chairman Christoph Franz told the Swiss newspaper Handelszeitung. He acknowledged that such a move would be controversial, but argued that a mandate would create "freedom in other areas" by halting the virus' spread and potentially ending lockdowns. Franz's statement is his own "personal opinion," Roche told Reuters. The Swiss drugmaker isn't developing a COVID shot but has teamed up with Regeneron to help produce its antibody cocktail.
The pressure is on for China to share data on its COVID-19 vaccine candidates. Brazil suspended a late-stage trial of Sinovac's shot on Monday after a serious patient health scare—right around the time Pfizer revealed its BioNTech-partnered vaccine had so far shown more than 90% efficacy in phase 3. Now, lack of transparency threatens to put China's vaccine diplomacy in jeopardy, health and political experts warn.
Shanghai-based Fosun, which has exclusive rights to Pfizer and BioNTech's shot in the Greater China region, has ID'd a storage site near the Hong Kong airport that could allow the drugmaker to store large amounts of the shot at ultracold temperatures, South China Morning Post reports. Meanwhile, some experts raised concerns that cold-chain hurdles associated with Pfizer's product may outweigh the potential benefits in China.
Meanwhile, Fosun snared a green light from China's National Medical Products Administration to run a phase 2 trial of Pfizer and BioNTech's mRNA-based vaccine hopeful in-country.
And Israel secured 8 million doses of Pfizer's shot—enough to vaccinate around half of the country's population of 9 million—Prime Minister Benjamin Netanyahu said. Pfizer confirmed Thursday a deal was in the works but did not divulge financial details. Deliveries are expected to start in January if the shot wins out in the clinic, Netanyahu said. Israel also has an agreement with Moderna for future purchase of its mRNA-based candidate.
Switzerland's drug regulator Swissmedic kicked off a rolling review of Moderna's vaccine candidate, mRNA-1273, potentially teeing up a swift approval for the Massachusetts-based biotech's shot. The process will allow Swissmedic to screen data from ongoing clinical trials as soon as it becomes available. Moderna last month completed enrollment for its phase 3 vaccine study and yesterday announced it had accrued enough cases for the first interim analysis.
The U.K. is weighing whether to tap U.S. data analytics company Palantir to improve the country's struggling contact tracing program, which has been hit with IT glitches, slow testing turnaround, user errors and more since its launch. The move could prove controversial, however; civil liberties groups have knocked Palantir for its work with the U.S. immigration service and for its links to national security agencies; the optics of the company handling hundreds of thousands of personal case contacts per week "are just not good," a person familiar with the talks told the Financial Times.
Synairgen's inhaled formulation of interferon beta-1a was well-tolerated in hospitalized COVID-19 patients and led to greater odds of recovery than placebo, and more quickly, too, the company said in a release. One hundred and one patients received either the drug or placebo once daily for 14 days. Those on Synairgen's drug, dubbed SNG001, were also more likely to recover to "no limitation of activity" during treatment, the drugmaker said. Story
Hungary is set to receive a sample of Russia's controversial vaccine within a week-and-a-half for laboratory testing, with plans to kick off clinical studies in December, the country's minister of foreign affairs and trade said. If all goes to plan, Hungary would become the first EU member state to trial Russia's shot. The United Arab Emirates, Saudi Arabia, Indonesia, the Philippines, India, Brazil, Mexico and former Soviet republics have so far expressed interest in the vaccine.
And Russia on Wednesday said its shot candidate, Sputnik V, has so far shown 92% efficacy in a late-stage trial. The data are based on the first 16,000 patients who received either the shot or placebo in Russia's 40,000-person phase 3. Researchers were able to confirm 20 COVID-19 cases among that group, split between those given the vaccine and the control arm. The results are set to be published in a peer-reviewed journal, Russia's sovereign wealth fund said.
UPDATED: Thursday, Nov. 12 at 3:15 p.m. ET
While mRNA vaccines from Pfizer and Moderna are already in phase 3, German biotech CureVac is touting a storage advantage for its midstage candidate. The late-stage shots require storage at subzero temperatures, complicating distribution and use, while CureVac's candidate can be kept at refrigerated temperatures. Story
Incorporating GlaxoSmithKline's adjuvant technology, Canadian biotech Medicago pushed its COVID-19 vaccine into phase 3 testing. The plant-derived vaccine candidate recently succeeded in a phase 1 trial, but it'll now face a bigger and more important study. Story
A few days after Eli Lilly scored an FDA emergency use authorization for bamlanivimab, analysts are concerned the med's restrictive label may shrink sales of that medicine and Regeneron's antibody, which is under FDA emergency consideration. Story
Johnson & Johnson, in phase 3 testing with its COVID-19 vaccine, is well on its way to producing 1 billion doses in 2021 as planned and is looking ahead to 2022, VP of strategic initiatives Paul Lefebvre said in an interview. While manufacturing has set back some players, the company took a deliberate approach in preparing to deliver on its lofty goals. Story
The early data for Pfizer and BioNTech's mRNA vaccine candidate "open the floodgates" for the vaccine technology for infectious diseases, SVB Leerink analyst Daina Graybosch said in an interview. But that doesn't mean the tech will succeed in other disease areas. Story
UPDATED: Thursday, Nov. 12 at 9:22 a.m. ET
Moderna hit the needed number of patient infections in its phase 3 vaccine trial to move ahead with the first interim analysis. Because of a significant uptick in observed COVID cases across trial sites last week, the drugmaker expects its first data analysis to cover substantially more than 53 cases—the target required to kick off an initial review of its mRNA shot.
AstraZeneca's cancer med Calquence failed to help patients hospitalized with respiratory symptoms of COVID-19, the drugmaker said in a release. The BTK inhibitor missed its primary endpoint in the drugmaker's phase 2 to "increase the proportion of patients who remained alive and free of respiratory failure." No new safety signals arose, AZ said.
In the race for a vaccine, drugmakers aren't competing with one another, but against the virus itself, Johnson & Johnson CEO Alex Gorsky said. "The best possible position we could be in is where we have four or five or six of these vaccines available in the year 2021," he said. Gorsky said that mounting case numbers underline the importance of sustained efforts to prevent the virus' spread, adding that the pandemic has exposed a need to improve public health worldwide.
Amgen and Japanese drugmaker Eisai signed on to University of Pittsburgh Medical Center trial aiming to use artificial intelligence to assess and adjust COVID-19 treatments. Amgen's newly acquired Otezla (apremilast) and Eisai's experimental eritoran—both anti-inflammatory drugs—will be evaluated by reinforcement learning, a type of AI that can modify treatment protocols in real time according to data on each patient's reaction to the drug.
Meanwhile, Serum Institute of India completed enrollment for its phase 3 trial of AstraZeneca's vaccine candidate, the company said in a statement. The Institute has so far produced 40 million doses of the shot. AZ's vaccine is the 'most advanced' shot in clinical testing in the country, the Indian Council of Medical Research said.
Médecins Sans Frontières (MSF) wants governments to push drugmakers to open the books on their vaccine licensing deals so that the public, countries and treatment providers can secure shots at a fair price. “As long as we don’t know what’s in these deals, pharma will continue to hold the power to decide who gets access when, and at what price,” said Kate Elder, senior vaccines policy advisor for MSF's Acces Campaign. The current lack of transparency puts equitable access to a COVID-19 vaccine "in jeopardy," she added.
A viral mutation could dampen hopes for the leading pack of vaccines, which tackle the current version of the virus, Bloomberg analyst Sam Fazeli wrote in an op-ed. He cited Denmark's recent culling of its mink population after the virus spread through the animals and mutated before jumping back into humans. Meanwhile, mutations could easily crop up in people too, if the virus continues to spread unchecked.
Mallinckrodt is teaming up with Pharmerit to run a retrospective chart review study assessing its INOmax nitric oxide gas as an inhalation therapy for patients with COVID-19 respiratory complications. The drug is approved to treat respiratory failure associated with pulmonary hypertension in infants. The partners will collect data from around 200 hospitalized patients treated with INOmax for at least 24 hours between January 1 and July 31 of this year.
UPDATED: Wednesday, Nov. 11 at 3:00 p.m. ET
Vaccines from Johnson & Johnson and Sanofi and Novavax may be better suited to global distribution than Pfizer's candidate, which requires two doses and ultracold storage. J&J's shot, in testing at a single dose, is expected to remain stable for two years at minus 20 degrees Celsius and for upward of three months at refrigerator temps. Meanwhile, Sanofi and GSK's two-dose recombinant protein vaccine can be stored at 35.6 to 46.4 degrees Fahrenheit, a spokeswoman said. Story
Pfizer is already weighing options for a second-generation version of its vaccine, including a powder formulation that could eliminate the need for ultracold storage, chief scientific officer Mikael Dolsten told Business Insider. That formulation, storable via refrigeration, could roll out as early as next year, he added. Story
On Monday, as strong efficacy data on Pfizer's shot raised the company's shares nearly 8%, CEO Albert Bourla sold off 132,508 shares, more than 60% of his total holdings, for $5.6 million. Bourla sold the shares under a SEC rule that allows company insiders to arrange stock sales in advance, before they have access to "material nonpublic information." Story
Kaiser Health News posed a slate of questions about Pfizer's vaccine after Monday's data reveal. The length of immunity conferred by the shot and its efficacy in at-risk groups topped the list. KHN also wondered whether a quick authorization could derail ongoing trials of other candidates, among other things.
More than a few people are struggling with the name for Eli Lilly's antibody therapy bamlanivimab, which won an emergency OK on Tuesday in non-hospitalized COVID patients at high risk of severe disease. The tongue-twisting drug name even received some gentle ribbing on Fallon Tonight:
Meanwhile, Qiagen teamed up with cell therapy-focused startup TScan Therapeutics to develop a COVID-19 diagnostic designed to offer a comprehensive profile of a person's immune response to the disease. TScan will pivot its genome-based, high throughput discovery platform for parsing T-cell receptors to determine how those immune cells react to COVID-19. By focusing on T cells rather than antibodies—which may diminish over time—TScan figures its test could offer a more reliable way to screen for the virus over a longer period after infection. Story
UPDATED: Wednesday, Nov. 11 at 9:30 a.m. ET
Pfizer and BioNTech clinched a deal to supply 200 million doses of their experimental vaccine to the EU, with an option for another 100 million doses. The partners will crank out shots at BioNTech's German manufacturing sites and Pfizer's production site in Belgium, and aim to start deliveries by year-end, should the vaccine pass muster in the clinic. Story
And if everything goes to plan with Pfizer's data submission, the U.S. could start immunizing people in December, Health Secretary Alex Azar said. Pfizer expects to have safety data for an emergency nod as early as next week. After authorization, the U.S. would receive around 20 million doses per month and aim to vaccinate nursing home residents, healthcare workers and first responders by the end of January.
WHO director general Tedros Ghebreyesus welcomed "promising news" on the efficacy of Pfizer and BioNTech's vaccine, while reiterating the agency's commitment to fair distribution of an eventual shot. Ultracold storage requirements for the partners' mRNA-based vaccine have raised concerns about access in low- and middle-income regions. Meanwhile, the shot "presages significant cold-chain challenges for African countries," the WHO's regional director for Africa said.
And the Indian government ought to hammer out a vaccine distribution strategy to ensure Pfizer's shot is made widely available, lawmaker Rahul Gandhi said Wednesday. For its part, Pfizer is "exploring opportunities" to make the shot available in-country, the drugmaker told Business Standard. The country's health secretary confirmed India was in talks with Pfizer and said it could could strengthen its cold-chain capacity for the vaccine.
Rural hospitals in the U.S. also lack funds to secure the ultracold freezers needed to store Pfizer's vaccine, Stat reports. The CDC has recommended against state health departments purchasing the high-end freezers, given that other shots with less stringent storage requirements are likely on the way. Meanwhile, areas with smaller populations may struggle to use up Pfizer's 1,000-to-5,000 dose shipments before they expire. Pfizer, for its part, is working on smaller-dose shipments for 2021.
Plus, states say they still lack government funding necessary to meet widespread vaccination goals in the U.S. The CDC in September announced $200 million in grants designed to support shot planning, while organizations representing state health officials and immunization managers have called for around $8.4 billion more, the Chicago Tribune reports. Among the mounting costs states will face? Securing ultracold freezers, setting up and staffing vaccination centers, running vaccination messaging campaigns and more.
Meanwhile, the technology behind Pfizer and BioNTech's vaccine may have lasting effects beyond the COVID-19 pandemic. "It provides a glidepath for using mRNA technology for other vaccines, including cancer, autoimmune disorders, and other infectious diseases, as well as vehicles for genetic therapies," said Peter Hotez, vaccine researcher and dean at Baylor's National School of Tropical Medicine. "It really does help accelerate the whole biomedical field."
New daily cases in the U.S. passed 139,000 yesterday as COVID-19 hospitalizations hit an all-time high of 61,964, The New York Times reports. The country is now averaging more than 111,000 new cases per day, according to The Times' database.
UPDATED: Tuesday, Nov. 10 at 3:12 p.m. ET
CureVac, advancing an mRNA vaccine candidate, unveiled more data showing that the vaccine triggers potentially protective immune responses. Still it isn't known whether the vaccine can match the high efficacy bar just hit by Pfizer and BioNTech's vaccine in interim data, and tolerability questions linger. Story
After Pfizer unveiled positive interim findings for its mRNA vaccine Monday, HHS secretary Alex Azar said in network interviews the government has plans in place to begin vaccinations next month and into January, contingent on a review of the data and regulatory recommendations. Reuters story
Four months after launching, Massachusetts biotech Adagio Therapeutics scored an $80 million series B to push its COVID-19 antibody into the clinic next year. FierceBiotech story
UPDATED: Tuesday, Nov. 10 at 9:15 a.m. ET
Amid ongoing hype—and questioning—about Pfizer's vaccine results, CEO Albert Bourla told CNBC he'd be willing to get the vaccine first to ease concerns about its risk-benefit profile—but he's not sure that would be ethical given other populations might need it more. Forbes story
Pfizer partnered with Germany's BioNTech to advance the vaccine, which was originally developed by the husband-and-wife duo of Ugur Sahin and Oezlem Tuereci. Both are the children of Turkish immigrants. Reuters story
As it was advancing the program, Pfizer prioritized transparency, diversity and funding independence. There are numerous reasons behind those decisions, including vaccine skepticism, a failed historical experiment and more, outlined in a new Marketplace article.
Since Pfizer unveiled the results in a Monday press release, scientists have been pushing for more details. The "encouraging" figures are still the "earliest of results possible," Mayo Clinic vaccine researcher Gregory Poland told Reuters. It also isn't clear yet how well the vaccine protects older trial participants, whether it reduces severe disease or how long protection lasts. Another vaccine expert, Peter Hotez, told Science it's "always hard to read the tea leaves of a company press release." Reuters story | Calgary Herald story | Science story
While the vaccine data are "very good news," science writer Laurie Garrett pointed out that serious concerns remain, including the pandemic's current resurgence in the U.S. and the lame-duck leadership in federal government. Plus, there's much more to learn about the vaccine given the current state of the research.
President Donald Trump on Twitter alleged Pfizer waited to share the early data until after the election. Bourla, for his part, told CNN the company delivered the news "when the science told us the data was available." Business Insider story
The vaccine is expected to reach different countries at different time. India's Economic Times reports that country won't see it "anytime soon" and that ultracold temperature requirements would make it tough for a national immunization strategy there. The U.S., U.K. and other countries have placed advanced orders, the report says. Story
In China, Fosun Pharma's stock price soared after the news on hopes that the company will be able to launch the shot there. The drugmaker is partnered with BioNTech and may be able to launch after a bridging study, the South China Morning Post reports.
After efforts to re-purpose medicines and manufacture needed drugs to help fight the pandemic, Africa's Aspen is pivoting to focus on vaccines. The company recently signed on to help manufacture Johnson & Johnson's candidate. Bloomberg story
UPDATED: Monday, Nov. 9 at 3:28 p.m. ET
After Pfizer reported promising efficacy data for its vaccine, experts and analysts started weighing how other companies might fare with their own programs. Because Moderna is also advancing an mRNA program, the company is in a solid position with its mRNA-1273, experts said.
The Pfizer results "provide strong validation" of the mRNA vaccine platform, Chardan analyst Geulah Livshits wrote to clients. The biotech's vaccine has less restrictive cold chain requirements than Pfizer's does, so its program wouldn't necessarily need to meet the 90% efficacy mark to be used widely, the analyst wrote. In all, the Pfizer news is an "important positive read-across" for Moderna given the biotech's significant investment in its mRNA vaccine franchise.
Anthony Fauci, director of the NIAID, also said the Pfizer news bodes well for Moderna. Speaking with Stat, Fauci said Moderna "will likely have similar results."
Still, Evercore ISI analyst Josh Schimmer said the mRNA vaccines take longer to scale up than the subunit adjuvant program at Novavax and the viral vector program from AstraZeneca. The "right mix of approved vaccines" could mean adequate supply for the U.S. and well beyond" by next year's first quarter, he said. But if it's all up to mRNA vaccine players to deliver the needed doses, it could be the third quarter before adequate supplies are available.
Meanwhile, positive vaccine news could raise questions for companies working on leading COVID-19 therapeutics. Gilead, Eli Lilly and Regeneron are key players, and Barclays analysts wrote that the Pfizer news “should raise further questions around the mid-to-long-term durability" of revenue from potential coronavirus therapeutics. The analysts noted that drugs will still be needed even after vaccines launch. Story
UPDATED: Monday, Nov. 9 at 9:23 a.m. ET
Pfizer and BioNTech's vaccine candidate, BNT162b2, boasted more than 90% efficacy in preventing COVID-19 in patients without prior evidence of infection, interim data from the partners' phase 3 showed. That number could change as more data roll in, Pfizer said. The interim analysis covered 94 patients; the company will need to submit data on 164 patients and build up at least two months' worth of safety data before it can file for an emergency nod, potentially around Thanksgiving. Story
Novavax's recombinant nanoparticle-based vaccine won fast track designation from the U.S. Food and Drug Administration. The drugmaker aims to kick off late-stage trials in the U.S. and Mexico by the end of November and expects an ongoing phase 3 in the U.K. to complete enrollment in that same timeframe. Interim data from that trial could be ready as early as the first quarter of 2021, Novavax said.
President-elect Joe Biden plans to convene a 12-member coronavirus task force Monday, led by former surgeon general Vivek Murthy and ex-FDA commissioner David Kessler. Biden has already set forward a number of COVID-19 goals, including doubling the number of drive-through testing sites, establishing a U.S. public health job corps and boosting production of masks, face shields and other protective equipment.
Plus, some Biden advisers have already met with drug and vaccine makers that are part of the government's Warp Speed program, Bloomberg reports. According to the news service's sources, advisers told the companies that his administration wouldn't want to disrupt the program's work in getting new drugs and vaccines to market. Instead, it wants to be ready to help when Biden moves into the Oval Office.
Serum Institute of India has produced up to 30 million vials of AstraZeneca's vaccine hopeful, dubbed Covishield in-country, the joint commissioner of the Pune division of the Food and Drug Administration said. The company is now seeking an emergency license for the shot. Results from an Indian phase 3 are expected by year-end, and Serum Institute has kicked off production to meet demand ahead of an authorization.
Meanwhile, AstraZeneca agreed to supply around 22 million vaccine doses to Argentina, with plans to start distributing the shots in the first half of 2021. That delivery timeframe is subject to the success of ongoing trials and local regulatory approval, AZ said in a statement circulated by the Argentine government Saturday.
Sanofi, Eli Lilly Korea and Roche Korea are tapping their early retirement programs to scale back sales forces amid the COVID-19 outbreak, Korea Biomedical Review reported. The move comes as more drugmakers turn to digital sales tools—a transition already in the works back in 2019 and accelerated by the pandemic. Specifically, Sanofi plans to encourage some of its chronic disease sales reps to choose early retirement, while Lilly aims to dial back drug reps in the country by 20%.
UPDATED: Friday, Nov. 6 at 9:19 a.m. ET
Novartis' arthritis med Ilaris, also known as canakinumab, failed to keep seriously ill patients off ventilators and didn't beat standard of care at preventing deaths, phase 3 data showed. The trial tested the drug in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome. Novartis is also testing Jakafi against the disease and joined forces with Molecular Partners in October to develop two DARPin therapies as potential treatments.
AstraZeneca plans to bring ex-U.S. vaccine data before the FDA once it obtains results from its British, South African or Brazilian trials—even if those data precede a readout from the drugmaker's U.S. phase 3, EVP of biopharmaceuticals R&D Mene Pangalos told Reuters. The FDA has set expectations for safety and efficacy, but hasn't said those data must come from U.S. studies, Pangalos said, adding that an approval would be unlikely to disrupt its ongoing stateside trial.
The U.K.'s Recovery Trial on Friday started investigating aspirin to see whether the cheap and widely-available drug could reduce the risk of blood clots in hospitalized COVID patients. The trial expects to dose at least 2,000 patients with aspirin plus standard of care and will primarily assess mortality after 28 days. The researchers are also curious whether the drug can reduce the length of hospitalization and need for ventilation.
Regeneron is optimistic the FDA will authorize its antibody cocktail but still doesn't know the timeline for that decision, CEO Leonard Schleifer said on a Thursday earnings call. The company earlier this year said clinical data showed the drug reduced medical visits in patients with mild or moderate disease. Regeneron could make about 80,000 doses available by the end of this month and have 300,000 doses ready by the end of January, the company said. Story
Amgen staffers who have worked remotely since March will continue to work from home until the end of June 2021, Judy Brown, SVP and site head at Amgen's global headquarters, said in an email obtained by Acorn. Brown reasoned that the Greater Los Angeles area, where the company is based, is unlikely to see a drop in cases before spring, adding that a vaccine probably wouldn't become available during that timeframe, either.
UPDATED: Thursday, Nov. 5 at 3:55 p.m. ET
Hologic's revenue may have slipped last quarter, but its COVID-19 testing business has continued to soar, helping the company net more than $1.3 billion in sales in the final quarter of its 2020 fiscal year. The company's molecular diagnostics division alone managed to pull $818.9 million for the period—almost as much as the $865.8 million in total revenues Hologic made during the last quarter of 2019. Story
Children with COVID-19 produce fewer, weaker antibodies than adults, a study published in Nature Immunology found. While both adults and children in the study produced COVID-19 antibodies, children mainly produced one kind, called IgG, which binds to the virus' spike protein. Adults, meanwhile, made multiple types of antibodies—better than IgG at neutralizing the virus—that bound to the spike protein and other viral proteins, too.
Contract research organization Parexel teamed up with bioanalytics firm Synexa Life Sciences and blood-drawing specialist Drawbridge Health to offer Synexa's serology test, which can help identify whether a person has had a virus such as SARS-CoV-2, and Drawbridge's OneDraw remote blood collection device to customers as part of the company's myriad COVID-19 projects and trials. Parexel cited an "urgent need" for accurate serology testing that also limits risk of exposure to COVID-19—which it thinks its new pact can deliver on. Story
The time has come for the U.S. to develop a testing strategy to track asymptomatic spread of COVID-19, CDC director Robert Redfield said. The CDC in August issued a recommendation that people who had come into close contact with an infected person didn't necessarily need to get tested unless they were at higher risk of infection or severe disease. The agency changed its tune in September, urging anyone who has been in close contact with an infected individual to get tested, even if they don't display symptoms.
An oversight panel called for changes at the World Health Organization, stressing that it was essential the agency maintain "neutrality and political independence." The panel urged the U.N. agency to establish a graded system to "alert and engage the wider international community at an earlier stage in a health crisis," and also said the WHO's Emergency Program is in "a constant struggle to mobilize resources, with staff forced to juggle competing priorities simultaneously."
UPDATED: Thursday, Nov. 5 at 9:30 a.m. ET
AstraZeneca is poised to supply "hundreds of millions" of vaccine doses on a rolling basis once its shot is authorized, CEO Pascal Soriot told Bloomberg, despite delays in early U.K. shipments. Soriot added that a recent resurgence in cases had enabled scientists to gather necessary clinical data. A day earlier, Kate Bingham, chair of the UK Vaccine Taskforce, had said just 4 million AZ doses would be ready by year-end in the U.K., rather than the 30 million doses the drugmaker had hoped to deliver by September.
Chile's drug regulator green lighted a clinical trial of AstraZeneca's vaccine, the country's President, Sebastian Pinera, said. The AZ study joins a Chilean trial of Johnson & Johnson's shot, plus a separate test of Sinovac's pandemic hopeful. The country has penned a deal for 10 million doses of Pfizer and BioNTech's shot and is looking to ink similar agreements with AstraZeneca, J&J and Sinovac, Pinera said. Elsewhere, Peru said J&J and AZ would kick off vaccine trials in the country next week.
And Bangladesh locked down 30 million AstraZeneca doses through Serum Institute of India (SII). The country will purchase 5 million doses from SII per month through Bangladeshi drugmaker Beximco, provided the shot is cleared by regulators, the country's health minister said.
The World Health Organization is going all-in on monoclonal antibodies, dexamethasone and repurposed meds—but not Gilead's Veklury (remdesivir)—in its scheme to provide COVID-19 drugs to low-income countries, an internal document obtained by Reuters showed. Unitaid, a health partnership co-leading the effort, confirmed that the scheme would not include Veklury, though it didn't comment on the reason for excluding the antiviral. A WHO trial reported in October found Gilead's drug offered little benefit in COVID-19 patients; Gilead has disputed those findings.
The U.S. charted more than 107,800 new COVID-19 cases Wednesday, according to The New York Times, setting a grim record for daily infections. Meanwhile, Maine, Minnesota, Indiana, Nebraska and Colorado also hit single-day case records.
Bharat Biotech could launch its shot as early as February, jumping ahead of its previously stated second-quarter rollout goal, a senior scientist at the Indian Council of Medical Research (ICMR) told Reuters. Bharat plans to kick off a late-stage study of its shot, Covaxin, this month. “It is expected that by the beginning of next year, February or March, something would be available," he added.
UPDATED: Wednesday, Nov. 4 at 3:00 p.m. ET
Britain will receive an estimated 4 million doses of AstraZeneca's vaccine by year-end, rather than the 30 million doses AZ had hoped to supply by September, UK Vaccine Taskforce chief Kate Bingham told lawmakers Wednesday. Earlier in the day, the chief investigator of the University of Oxford's vaccine trial said he was "optimistic" that AZ could deliver late-stage trial data before year-end, adding that doses were already in production. The U.K. in May penned a deal for 100 million doses of AZ's shot, which should now be available in the first half of 2021, Bingham said.
Russia aims to provide its citizens with tens of millions of doses of its Sputnik V vaccine by year-end, but production and quality control hurdles may deflate that number, The Bell reported. "We can't stabilize the vaccine, no one yet can," an unnamed exec at one of the Gamaleya Institute's four Russian manufacturing partners told the news outlet. Meanwhile, vaccine batches frequently miss the institute's quality control bar and attempts to launch bioreactors at scale have been "generally unsuccessful."
A COVID-19 breathalyzer test from Singapore's Breathonix achieved at least 90% accuracy when screening participants on-site for 60 seconds, the company said. An ongoing pilot study in 180 people showed an overall sensitivity of 93% and a specificity of 95%. The test, which uses a one-way valve and disposable mouthpiece, could be used for mass screening in high-traffic areas, Breathonix figures. Story
BD inked a contract with the Dutch Ministry of Health to supply an initial 1.2 million units of its rapid antigen diagnostic, the hand-held Veritor Plus system, this month, with another 8 million slated for delivery to the Netherlands by June of next year. The portable, point-of-care system won an emergency coronavirus nod from the FDA in July and a CE mark in September. Story
The FDA on Tuesday warned healthcare professionals that antigen tests could deliver false positives if users fail to follow instructions. The regulator encouraged labs to perform follow-up testing with a molecular assay when appropriate and cautioned that improper storage, failure to read testing results at the correct time and cross-contamination could all lead to inaccurate readouts. The warning follows reports of false positives from antigen tests in nursing homes and other healthcare settings.
UPDATED: Wednesday, Nov. 4 at 9:12 a.m. ET
Australia locked down 40 million vaccine doses from Novavax, plus 10 million doses from Pfizer and BioNTech, bringing the country's total vaccine investment up to more than $3.2 billion. If the shots win approval, they're expected to become available in Australia during the first half of 2021. The country earlier this year secured doses from AstraZeneca and the University of Queensland.
China's Fosun Pharma stopped development on BioNTech's first COVID-19 vaccine and will instead seek Chinese approval for the German shot maker's second candidate, currently in late-stage testing in the U.S. Fosun aims to run a bridging study that may enable it to use global data on the second candidate, BNT162b2. Pfizer and BioNTech chose that shot as their phase 2/3 candidate after it turned up a lower rate of side effects than their first prospect. Story
Speaking of Pfizer and BioNTech, the chair of the UK Vaccine Taskforce, Kate Bingham, is hopeful that strong interim data from the mRNA partners, plus AstraZeneca and the University of Oxford, will emerge in early December, potentially teeing up a vaccine rollout before year-end.
For its part, the University of Oxford is "optimistic" that it could unveil late-stage results on its AstraZeneca-partnered shot this year, said chief investigator of the university's vaccine trial, Andrew Pollard. As for whether the shot might be available before Christmas, "[there] is a small chance of that being possible but I just don't know," he said, adding that a shot would not be a panacea. “We will still have people getting this virus because it is just too good at transmitting.” Story
In people with symptomatic COVID-19, Quidel's rapid Sofia test was able to detect more than 80% of cases found by the slower, gold-standard PCR test—but when Quidel's test was used to randomly screen asymptomatic patients, it only picked up 32% of infections caught by the PCR method, a University of Arizona study found. It's possible the rapid test missed asymptomatic cases ID'd by the lab test because those people were carrying too little of the virus to spread it to others, one study author said.
The U.S. FDA ordered NovaBay Pharmaceuticals to stop claiming that its Avenova antimicrobial eyelid and eyelash spray can kill the SARS-CoV-2 virus. The company's website asserts that "an independent third-party laboratory study" confirmed its spray can fully inactivate the virus and recommends using it to eliminate airborne respiratory droplets. In a warning letter, the FDA pointed out that the NovaBay spray has no human data to back it up.
UPDATED: Tuesday, Nov. 3 at 3:16 p.m. ET
While most vaccine makers will pass their shots off to McKesson for U.S. distribution, Pfizer is taking matters into its own hands, Tanya Alcorn, VP for biopharma global supply chain at the company, said. Pfizer has developed a GPS and temperature-tracked thermal cooler to help transport its vaccine, along with a control tower that provides real-time alerts if temperatures deviate or a shipment runs late. Still, some officials remain concerned that vaccination centers won't have the cold-storage capabilities to house Pfizer's shot. Story
T cell immunity to the coronavirus may outlast antibodies in patients who've recovered from COVID-19, a recent U.K. study showed. Analyzing the blood of 100 patients six months after they had asymptomatic or mild disease, researchers found that while antibody levels dropped in some patients, T cell response endured. T cell response was also higher in patients who displayed symptoms while infected.
61,000 new coronavirus cases cropped up in children last week, more than any previous week in the pandemic, the American Academy of Pediatrics (AAP) reported. Severe illness due to COVID-19 in children is rare, but there is an "urgent need" to collect more data on the long-term impact of the disease in kids, AAP said.
Colorado State University is using the fecal matter and pooled spit of undergraduates to catch COVID-19 cases early, Kaiser Health News reports. The school's sewage review follows emerging research suggesting people shed the virus in feces early in their infections. The school is also conducting "paired" pooling of saliva samples, which allows testing of multiple samples at once without the need for much retesting if a pool of samples turns up positive.
UPDATED: Tuesday, Nov. 3 at 9:30 a.m. ET
Advocacy group Public Citizen urged Gilead Sciences to give up the priority review voucher it earned alongside its FDA approval of Veklury, also known as remdesivir. The voucher can be used to speed up FDA review time for another drug or sold—and previous sales have netted hundreds of millions of dollars. Public Citizen called the incentive "unnecessary" and "inappropriate" given Gilead's expected Veklury sales. Story
The Coalition for Epidemic Preparedness Innovations (CEPI) will fund development of Clover Biopharmaceuticals' protein-based S-Trimer vaccine through a global phase 2/3 trial, bringing its total investment in the program to upward of $328 million. Beyond the upcoming efficacy trial, pegged to start before year-end, CEPI's investment will fund studies in people with autoimmune conditions, children, pregnant women and more. If the shot clears the clinic, Clover and CEPI aim to make hundreds of millions of doses available per year through the WHO's Covax effort. Story
Israel dosed the first two patients in a phase 1 trial of its coronavirus vaccine, Brilife, developed by the Israel Institute for Biological Research. A phase 2 trial that seeks to enroll 960 healthy volunteers is expected to kick off in December, while a 30,000-person phase 3 is pegged to start in April or May 2021 if warranted.
The pandemic is entering a new, "deadly phase," White House coronavirus coordinator Deborah Birx said in a private memo to White House officials obtained by The Washington Post. Birx called for consistent messaging about masks, hand-washing and social distancing. It's not about lockdowns, she wrote, but rather, "an aggressive balanced approach that is not being implemented.” Her comments put her at odds with President Donald Trump, who says the nation is "rounding the corner" on the pandemic.
Scientists at the University of Washington School of Medicine developed a nanoparticle vaccine candidate that sparked neutralizing antibody levels in mice ten times higher than those seen in recovered patients—and at a much lower dose than required for vaccination with the SARS-CoV-2 spike protein. The University licensed its candidate to Icosavax for further study. Amgen agreed to manufacture a key intermediate for initial R&D while South Korea's SK Bioscience advances its own studies on the shot.
South Korea's new minister for food and drug safety, Kim Gang-lip, made his first goal to "mobilize our regulatory capacity as much as possible to help develop a Covid-19 treatment and vaccine that people can trust.” Kim also aims to boost the Korean drug regulator's global competitiveness and is seeking "international regulatory harmonization."
UPDATED: Monday, Nov. 2 at 3:20 a.m. ET
CureVac aims to build an mRNA vaccine that generates a balanced immune response similar to the body's natural reaction, and now it's armed with interim phase 1 data supporting that goal. In the dose escalation study, CureVac's highest 12-microgram dose—pegged to advance into a phase 2b/3—raised binding and neutralizing antibody levels to those seen in a set of 67 seriously ill COVID-19 patients, the company said. Story
Pfizer and Bristol Myers Squibb launched a new campaign to promote doctor visits amid the pandemic. "No Time to Wait," which covers broadcast and streaming TV and radio, as well as digital and social media, focuses on three conditions: atrial fibrillation, deep vein thrombosis and pulmonary embolism, all treated by the partner's anticoagulant Eliquis. Story
Johnson & Johnson's weekly video series, "The Road to a Vaccine," has racked up more than 100 million views since launching in April. Hosted by journalist Lisa Ling, the show features J&J researchers and execs, public health officials and advocates in conversation about vaccine development, mental health, racial disparities and more. “At the end of the day, science is about society, and society has to understand the processes of science,”J&J communications exec Seema Kumar said of the series during Fierce Pharma Marketing’s Digital Pharma Innovation Week. Story
Massachusetts-based biotech incubator LabCentral, together with lab facility provider BioLabs, launched the Cambridge Consortium for Rapid COVID-19 Tests (CCRCT) to assess and validate COVID-19 diagnostics that people can use at home. CCRCT last month started a trial of a 15-minute, self-administered antigen test made by LabCentral alum E25Bio. Story
Hologic snared a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, with the goal to provide 13 million COVID tests per month by January 2022. The company's Panther Fusion and Aptima SARS-CoV-2 assays won emergency nods in March and May, respectively, and the FDA in September OK'd Hologic's Panther Fusion test to screen asymptomatic patients. Story
Novavax inked a 15-year lease for about 122,000-square-feet of offices in Gaithersburg, Maryland, for manufacturing, office space and R&D, while an affiliate of the company bought 9.7 acres in Gaithersburg for future development. Novavax has scored up to $2 billion from the U.S. government and CEPI for its COVID-19 vaccine program; the company's shot is currently in late-stage testing in the U.K. and a large phase 3 trial in the U.S. and Mexico is set to kick off later this month. Story
Fifty-nine percent of Russians say they wouldn't get the country's Sputnik V vaccine, an October poll from Russia's Levada Center showed. That number rose from 54% of respondents unwilling to get the shot in August. Meanwhile, just 31% of people polled in October said they would get the shot, down nearly nine percentage points from August. Levada polled 1,601 Russians between Oct. 22 and Oct. 28.
UPDATED: Monday, Nov. 2 at 9:15 a.m. ET
Johnson & Johnson hopes to start testing its vaccine in children ages 12 to 18 as soon as possible, said Jerry Sadoff, a vaccine research scientist at J&J's Janssen unit. The company could eventually test its shot in even younger children, Sadoff said. The vaccine platform J&J's using for its COVID-19 shot, AdVac, is also used in an Ebola vaccine that's been given to infants, children and pregnant women.
Africa's biggest drugmaker, Aspen Pharmacare, struck a preliminary deal to produce Johnson & Johnson's vaccine in South Africa. The company would carry out manufacturing and packaging work at its Port Elizabeth plant, which boasts capacity for 300 million doses a year, if the shot snares regulatory approval in the country.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) awarded £1.5 million ($1.9 million) to GenPact for an artificial intelligence tool to process potential side effects and safety signals from an approved vaccine. Based on historical vaccination data, the MHRA expects to see between 50,000 and 100,000 side effect reports for every 100 million doses administered over a six to 12 month span.
Bharat Biotech aims to launch its vaccine hopeful in the second quarter of 2021, pending an approval in India, the company's executive director said. The shot, Covaxin, has a ways to go: Bharat expects to kick off recruitment for a phase 3 trial this month.
At a rally early Monday morning, President Donald Trump floated the possibility of firing the nation's top infectious disease expert, Anthony Fauci, after the election. During the event, Trump once again said the country has "turned the corner" on the pandemic. But in a Washington Post article published Saturday, Fauci said the U.S. "could not be positioned more poorly" ahead of the winter. Story
The U.S. needs to make an "abrupt change" in public health practices and behaviors to counter the pandemic, Anthony Fauci told The Washington Post. The coronavirus task force is meeting infrequently and has much less influence with the President now, Fauci said. And the NIAID chief said Scott Atlas, a neuroradiologist who has become Trump's favored pandemic advisor is "a smart guy who’s talking about things that I believe he doesn’t have any real insight or knowledge or experience in."
Meanwhile, Thanksgiving will be a COVID-19 "inflection point," former FDA commissioner Scott Gottlieb said. "There are about 23 states that are accelerating the spread right now," he added. It's unlikely that the entire country would lock down again, as Europe is doing, though Gottlieb said he expects states to take local action as hospitals become overwhelmed.
The U.K.'s Department for Business, Energy & Industrial Strategy came to the defense of Kate Bingham, chair of the country's vaccine task force, after The Sunday Times published an article alleging she had disclosed "sensitive" information about U.K. investments in COVID vaccines and therapeutics. Her presentation, for a U.S. women's conference, had been cleared by the government, the department said, and Bingham said little that experts at the conference couldn't deduce themselves.
Siberia-based drugmaker Pharmasyntez asked the Russian government for permission to produce a generic version of Gilead Sciences' Veklury, or remdesivir, despite lacking a patent or license. The drugmaker wrote to Gilead in July but did not hear back, and it is now asking the Russian government for a compulsory license, which would allow it to make a remdesivir generic without Gilead's OK.
Editor's note: This article was corrected to show that the Department for Business, Energy & Industrial Strategy, not BIA, issued the statement about Kate Bingham.