FDA panel recommends COVID-19 vaccine for emergency use

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 coronavirus 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, the 95% effectiveness of the Pfizer-BioNTech vaccine 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 the 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 day-long discussion.

The FDA analysis builds a case that this vaccine should be authorized for emergency use, a quicker approach than the one for full-blown marketing approval.

One goal of the public meeting was to provide transparency about the evidence for the vaccine. Another was to build confidence in the process.

At an earlier 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.” During Thursday’s meeting, there were no surprises 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 pregnant women about whether to get the vaccine. Also, there was limited clinical data about the vaccine in 16- and 17-year-olds.

There were also questions about the severe allergic reactions that two people in the U.K. had after getting the vaccine. The FDA wants more information to understand what happened.

The FDA’s pre-meeting 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.

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