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On the edge of a key COVID-19 decision: Five questions answered

By Anna Edney, Bloomberg News on

Published in News & Features

WASHINGTON — The coming week could mark an early turning point in the U.S. battle against COVID-19. Advisers to the Food and Drug Administration are set to review the first vaccine and their guidance could speed authorization, clearing the way to making it a top weapon against the virus.

An advisory panel made of top medical experts will help the agency gain outside perspective in reviewing an experimental shot from Pfizer Inc. and its German partner BioNTech SE before any final ruling is made on whether its use can be authorized on an emergency basis.

The meeting is set for Thursday. Here are five key points to help clarify the approval process:

Queston: Why are they meeting?

Answer: FDA Commissioner Stephen Hahn pledged earlier this year to hold public advisory committee meetings for each COVID-19 vaccine that seeks emergency authorization. That vow came after trust in the agency, as well as any vaccine that might be made available, waned following President Donald Trump's push for a vaccine to be approved ahead of the presidential election in early November.

Q: What's the time line?

 

A: Two days before the panel meets in what is expected to be a lengthy session, the advisers and the public will get their first hint of the agency's view of the clinical trial data with the release of extensive briefing documents and comments from the FDA staff.

The briefing documents are also likely to include questions the FDA wants its advisers to answer as well as specific wording for any final vote. Typically, advisory committees vote at the end of a meeting to indicate whether they think the FDA should approve the product under review, but not always.

Q: Must the FDA accept the recommendations?

A: No. The agency often is in agreement with an advisory committee, but there have been instances where it takes the opposite stance.

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