An independent FDA advisory committee on Thursday said that the benefits of Pfizer's coronavirus vaccine outweigh the risks, setting the stage for the agency to authorize emergency use of the shot for people 16 and older.
The panel — comprised of academic scientists, doctors and officials from other federal health agencies — voted 17 to 4 in favor of the vaccine, with one member abstaining.
The FDA’s top vaccine official, Peter Marks, has said that the agency could greenlight the vaccine within days, after an internal review concluded that the shot showed “a favorable safety profile, with no specific safety concerns.”
The Trump administration is ready to launch a massive vaccination campaign as early as Monday, which public health experts say is the country’s best bet to end a pandemic that has killed nearly 290,000 Americans and infected 15.4 million so far.
The Pfizer vaccine, developed by the company's German partner, BioNTech, is the first to undergo FDA review. It proved 95 percent effective at preventing disease in a 44,000-person U.S. trial whose peer-reviewed results were published Thursday in the New England Journal of Medicine.
Members of the FDA advisory committee supported authorizing the vaccine but had questions about possible allergic reactions reported in the U.K. Several of the experts also pushed unsuccessfully for the panel to endorse a narrower authorization that would leave out some teens and population groups at lower risk from the virus.
The panel also debated when U.S. clinical trial participants who got a placebo should get the real vaccine, and whether the vaccine could be given as one dose instead of two, after data published this week showed a swift immune response after a single jab.
President-elect Joe Biden issued a statement applauding the progress toward a vaccine — although his press release mistakenly commended the Food and Drug Administration for approving the shot, something that is not likely to occur for months. Approval is a higher bar than the emergency authorization currently on the table.
"In a ham-handed attempt to claim credit for the [Trump] Administration’s [Operation Warp Speed], the Biden team falsely reports FDA approval before it is granted," White House Deputy Press Secretary Brian Morgenstern tweeted after the Biden release.
Despite the FDA advisory committee's vote in favor of the vaccine, there are still lingering questions about who should — and shouldn't — get it. There are fresh concerns after reports from the U.K. this week that two health care workers with serious, known allergies had allergic reactions after handling the shots. The U.K. on Wednesday said that people with a “history of a significant allergic reaction” shouldn't receive the Pfizer vaccine, which it authorized earlier this month.
"There are 10 of millions of people in [the United States] who carry EpiPens with them, because they have peanut allergies, because they have egg allergies, who are going to believe now that they can’t get this vaccine.That’s a lot of people," said Paul Offit, a University of Pennsylvania vaccine expert on the committee. "We need to drill down on those two people in the U.K." and understand how severe the reaction could be, he added.
FDA on Thursday asked Pfizer and BioNTech to add anaphylaxis — or life-threatening allergic reactions — to the list of adverse reactions they would monitor post-authorization as part of what is known as a pharmacovigilance plan. The agency is also discussing warning labels and contraindications with Pfizer and may include a warning that the vaccine should not be administered to anyone with severe allergic reactions to any component of other vaccines, said Marion Gruber, director of FDA's Office of Vaccines Research and Review.
Offit suggested given the vaccine to people with known severe allergies in a carefully controlled trial to quickly understand the risks and assure the public that this is not a serious problem, "because this issue is not going to die until we have better data." But he did not suggest FDA shouldn't authorize the vaccine for the broader population in the meantime.
The agency also called for more data on the vaccine's safety and efficacy in teens, pregnant women and people with allergies, though that would not stall emergency authorization. Pfizer is one of the only manufacturers studying its vaccine in children as young as 12 years old, but for now it is seeking permission to use the vaccine in people 16 years and older.
Younger people in Pfizer's clinical trial reported more adverse reactions, and more severe ones, to the vaccine, than did older trial volunteers, said Susan Wollersheim, a medical officer in FDA's biologics department. But overall reactions to the vaccine were relatively mild and included injection site pain, headaches or fever a day after inoculation.
Some committee members expressed concern before the vote that the authorization should be limited to people over 18, rather than 16 and older. The panel ultimately voted in favor of using the vaccine on those 16 and up, although teens are likely to be among the last to receive the vaccine — and could end up waiting until well into 2021.
The FDA advisory committee also explored the thorny question of when trial volunteers who got a placebo could receive the working vaccine.
Pfizer had pushed FDA for permission to give the vaccine to members of its trial's placebo group immediately after authorization. The plan that caused tension with the agency, because it would effectively end the randomized, controlled study without gathering enough data to answer questions about the vaccine's long-term safety and the duration of the protection it provides.
Now Pfizer has proposed following participants for six months after their second shot before those in the placebo group can get the vaccine.
Advisory panel members at Thursday's meeting suggested an alternative plan where placebo patients in the Pfizer trial could be first to receive the vaccine within their own priority group — such as essential workers or the elderly. That would ensure they would not push ahead of people at greater risk from the virus, but would still have an incentive to stay in the study.
Otherwise, trial participants who suspected they were in the placebo group could confirm that hunch by getting tested for antibodies and drop out of the study.
Pfizer representatives also pushed back on the suggestion of a single dose vaccine, echoing comments from CEO Albert Bourla on Tuesday after the positive data were revealed.
“It’s a very big mistake if anyone tries to go with only one dose,” Bourla said in a briefing with reporters. “The truth is we saw some protection from 12 days after the first dose, but clearly the protection is not full.”
People “need to take two doses to be protected,” he added.
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FDA advisory panel recommends use of Pfizer vaccine - POLITICO
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