- A committee of more than 20 leading scientists and doctors on Thursday voted to encourage the Food and Drug Administration to grant emergency-use authorization for Pfizer and BioNTech’s COVID-19 vaccine in the US.
- Their vote is not binding, but the FDA is expected to follow their advice.
- An FDA decision could come soon.
- For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.
A committee of 22 leading scientists and doctors on Thursday voted 17 to 4, with one abstention, in favour of encouraging the US Food and Drug Administration to grant emergency-use authorization for Pfizer and BioNTech’s COVID-19 vaccine in the US.
Their vote is not binding but rather is advice indicating the experts think that the benefits of the vaccine outweigh its risks and that it should be made more widely available.
Ultimately, it’s up to the scientists working inside the FDA to decide whether to sign off on the two-dose vaccine candidate. That decision was expected to come within minutes, hours, or days from the expert panel’s decision.
“FDA staff feel the responsibility to move as quickly as possible,” FDA Commissioner Stephen Hahn tweeted shortly after the vote. “However, they know they must carry out their mandate to protect the public health & ensure any authorised vaccine meets our rigorous safety and effectiveness standards.”
Hahn had previously indicated he’s nearly ready to give the green light for the Pfizer vaccine, though.
“Our initial assessment is that this is a vaccine that does meet our criteria,” he said on NBC News’ “Today” show Thursday morning, before the committee meeting.
Pfizer and BioNTech’s vaccine has been granted emergency authorization in other countries including the UK, Canada, and Bahrain. The New York-based drugmaker Pfizer and its German partner BioNTech said in November that the two-shot vaccine was found to be 95% effective at preventing symptomatic COVID-19 in a massive clinical trial.
The FDA convened the independent panel of experts Thursday to weigh in on Pfizer’s application. The group included some of the top virologists and medical experts in the nation, including Dr. Eric Rubin, an infectious-disease specialist who is editor in chief of The New England Journal of Medicine, and Dr. Paul Offit, a top vaccine expert at the University of Pennsylvania who co-invented the rotavirus vaccine.
There were 4 ‘no’ votes, and some experts raised questions around the inclusion of 16- and 17-year-olds in the authorization
In a virtual meeting hosted on Adobe Connect and punctuated by many mute miscues and WiFi issues, committee members listened to hours of presentations and debated lightly at the end of the day. One trial participant spoke during the public comment period in the afternoon, urging the FDA to authorise Pfizer and BioNTech’s vaccine for emergency use Thursday night by saying “let’s roll.”
Before the vote, there was some debate among experts about whether there was enough data to support authorizing the vaccine specifically for 16- and 17-year-olds, who were included in the wording of the FDA’s voting question. No vaccinated 16- or 17-year-olds got sick with COVID-19 during the trial â€” making it difficult to compare the effects of the vaccine with the trial’s placebo among that age group. Some on the committee expressed a desire to increase the minimum vaccination age to 18 until more data was available.
One of the four “no” voters, David Kim, told Business Insider that including 16- and 17-year-olds in the mix was his reason for voting against the question of the day.
“My ‘no’ vote was because of the inclusion of 16-17 year-olds,” Kim said in an email. “Unfortunately, I and other members who had also voted ‘no’ did not have an opportunity to explain our positions before the meeting was adjourned.”
Another expert who voted no was Dr. Archana Chatterjee, a paediatrician who is dean of the Chicago Medical School. She told CNN she wasn’t in favour of making the shot available for 16- and 17-year-olds.
“I want to make it very clear that I am fully supportive of the emergency-use authorization of this vaccine for adults 18 years and older,” she told CNN.
The reasons the other two members voted “no” were unclear. The group adjourned promptly, leaving no time for members to explain why they voted the way they did. Business Insider contacted each of the “no” voters for comment.
The panel discussed long-term safety of the shot
Dr. Cody Meissner, the chief of the pediatrics infectious-disease division at Tufts University School of Medicine, said during the meeting that he was “comfortable” with the available safety data, particularly given the urgency of this pandemic, which is killing thousands of Americans every day. Meissner was the lone abstention from the vote.
He added that any issues typically occur within the first 40 days after a vaccine is administered. There has been only one instance of vaccine injury more than 60 days after a shot being administered, and that was in an immunocompromised patient who received the live polio vaccine.
Oveta Fuller, a microbiology and immunology professor at the University of Michigan, and one of the committee’s four “no” voters, noted that the long-term protective effect of the shot was unclear.
“We’ve only been looking for two months,” Fuller said.
Others cautioned that it was uncharted territory because Pfizer and BioNTech’s vaccine is based on a new technological platform called messenger RNA.
Throughout the meeting, no panel member expressed substantive doubts about the overall merits of the vaccine, particularly in the benefits it could provide to the most vulnerable Americans, who would be prioritised.
One committee member suggested a new study on allergies
The UK approved Pfizer and BioNTech’s shot last week and began administering it Tuesday. Two recipients in the UK, however, both with histories of severe allergic reactions, had reactions Tuesday shortly after receiving their shot. Both fully recovered after a shot of epinephrine. Questions about what to do with people with severe allergies prompted some of the most lively discussions of the day.
Offit said Pfizer should run a smaller trial focused on people with food allergies, vaccinating them and watching them closely.
“This issue is not going to die until we have better data,” Offit said. “You’re talking about tens of millions of people who are not going to get this vaccine.”
The FDA is expected to approve the shot this weekend, kicking off the US’s largest-ever vaccine campaign
FDA officials signalled that vaccine authorization could come as soon as Saturday or Sunday, according to The New York Times. That authorization would kick off the largest vaccination campaign in the history of the US.
Operation Warp Speed, the federal government’s vaccine initiative, plans to start shipping doses to states within 24 hours of authorization. Warp Speed officials said 2.9 million doses of Pfizer’s vaccine would be sent out in an initial shipment.
The Centres for Disease Control and Prevention has suggested that healthcare workers and nursing-home residents, both groups who’ve been hard-hit by the pandemic, should be first in line. That’s just a recommendation, however, and states are free to decide how they want to allocate their vaccine supply.
The vaccine authorization would come at a critical time, as the number of COVID-19 deaths recorded in one day in the US on Wednesday surpassed 3,000 for the first time.
“We are pleased with the vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic,” Pfizer CEO Albert Bourla said in a statement after the panel voted.
A panel will review Moderna’s shot next week
Additional help is on the way.
The FDA is also reviewing another coronavirus vaccine developed by the Massachusetts biotech Moderna. The agency is planning to have another advisory committee meeting next Thursday to discuss that application. Moderna has said its two-dose vaccine was 94% effective at preventing COVID-19 in a late-stage clinical trial.
Warp Speed officials have estimated 20 million Americans could begin the vaccination process before the end of 2020, based on supply estimates for Pfizer’s and Moderna’s shots. Moncef Slaoui, the chief advisor for Warp Speed, has projected 30 million more Americans will be immunized in January, and 50 million more in February.
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