FDA Panel Recommends COVID-19 Vaccine For Emergency Use
BY SCOTT HENSLEY & RICHARD HARRIS
In a 17-4 vote, with one abstention, a panel of advisers to the Food and Drug Administration recommended Thursday that the COVID-19 vaccine being developed by Pfizer and BioNTech be authorized for emergency use during the pandemic.
The vote in favor of the vaccine was taken to answer the agency’s question: Do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in people age 16 and older.
The agency typically follows the advice of its expert advisers.
A quick FDA decision is expected given the state of the pandemic, 95% effectiveness of the Pfizer-BioNTech in preventing COVID-19 and a determination by the FDA that there are no specific safety concerns that would stand in the way of emergency use.
The stunning toll of the COVID-19 pandemic and the fact that this is first vaccine to make it this far is why so much attention was focused on the Thursday meeting.
On Tuesday, the FDA released its analysis along with an information packet from Pfizer. Those documents and testimony from agency and company officials Thursday were part of the daylong discussion.
The FDA analysis builds a case that this vaccine should be authorized for emergency use, a quicker approach than the one for a full-blown marketing approval.
One goal for the public meeting was to provide transparency about the evidence for the vaccine. Another was to build confidence in the process.
At another public meeting last Friday, the acting chair of this advisory committee, Dr. Arnold Monto, said, “Unless there are surprises … there will not be an issue in terms of efficacy.” There were no surprises during Thursday’s concerning the effectiveness of the vaccine.
The panel had questions about the limited data on some populations. For example there’s little advice to give to women who are pregnant about whether to take the vaccine. Also there was limited clinical data about the vaccine in 16- and 17-year-olds, too.
There were also the questions about the severe allergic reactions that two people had in the U.K. after getting the vaccine. FDA wants more information to understand what happened.
The FDA’s premeeting analysis found “no specific safety concerns identified that would preclude issuance of an EUA,” or emergency use authorization. That conclusion was affirmed in agency presentations during the meeting.
And in the end the panel agreed to recommend that an EUA be granted.
Joe Palca contributed to this report.