On the Edge of a Key Covid Decision: Five Questions Answered

(Bloomberg) --

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 up 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 Dec. 10. Here are five key points to help clarify the approval process:

1) Why are they meeting?

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.

2) What’s the time line?

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.

3) Must the FDA accept the recommendations?

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

Hahn has said he is leaving the final decisions up to Peter Marks, the head of the agency center that oversees vaccines, and other top officials in that office. Marks and the others in his office are career officials with the agency while Hahn was appointed by Trump.

4) What happens after the advisers are done?

Hahn and Marks have given estimates for FDA authorization that range from a few days to a few weeks following the meeting. The time line really depends on how straightforward the clinical trial data is.

Pfizer, in news releases, has said the vaccine appears to be safe and 95% effective, though the company hasn’t gone into great detail. But any complications within the data could extend the time as the FDA staff seeks to determine who the vaccine is best suited for, based on age or other factors including whether certain groups were found to have side effects or were not studied widely enough.

Operation Warp Speed officials expect to start distributing the vaccine within 24 hours of FDA authorization, with as many as 6.4 million doses immediately available. A separate advisory panel for the Centers for Disease Control and Prevention has recommended that the first doses go to health-care workers and long-term care residents, though states get the ultimate say.

5) Is that it?

Not by a long shot. The FDA wants vaccine makers that gain emergency authorization to seek full approval as soon as possible.

The agency is granting emergency clearance based on two months of safety follow-up after trial participants received the last shot in a two-dose regimen. Full approval requires six months.

This may prove difficult as vaccines become more available and people drop out of trials if they think they’re getting a placebo. Meanwhile, other U.S. programs will be tracking potential adverse effects in the public that weren’t seen in the clinical trials.

Medical experts including Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, have said it could take until late spring to immunize enough people to end the pandemic. In the meantime, Fauci and other health officials, have said that mask-wearing and social distancing should continue to battle a rising surge in cases.

©2020 Bloomberg L.P.