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BREAKING NEWS FROM MEG TIRRELL: FDA SAID TO PLAN EARLY DECEMBER ADVISORY MEETINGS TO DISCUSS COVID-19 VACCINES AHEAD OF POTENTIAL AUTHORIZATION

FDA said to plan early December advisory meetings to discuss Covid-19 vaccines ahead of potential authorization

Meg Tirrell

KEY POINTS

The FDA is said to have asked its vaccines advisory committee to plan to meet Dec. 8-10 to discuss Covid-19 vaccines.

The meetings could discuss both Pfizer and Moderna’s applications.

The advisory group is expected to weigh in before the FDA makes a decision on whether to clear the vaccines for market.

The Food and Drug Administration has asked a group of advisors to set aside three days in early December for potential meetings to discuss Covid-19 vaccines — a key step in the agency’s authorization process, according to a person familiar with the plans. The advisory group may be asked to weigh in on both Pfizer and Moderna’s vaccines, said the person, who asked not to be named because the plans aren’t yet public.

Wednesday morning, Pfizer and its partner BioNTech reported final efficacy results from their study, saying they’d reached the FDA’s required safety milestone and planned to submit their application to use the vaccine on an emergency basis within days.

Moderna is expected to pass that safety milestone imminently as well. The FDA requires two months of safety follow-up after half the participants in the trial have been fully vaccinated -- receiving two shots of the vaccine a few weeks apart. The company said Monday it planned to seek the FDA’s authorization within the coming weeks.

The regulator is expected to decide quickly on the vaccines after the meetings of the group, known as VRBPAC, for Vaccines and Related Biological Products Advisory Committee. If it gives the vaccines its green light, an advisory committee to the Centers for Disease Control and Prevention would meet to make recommendations on prioritization.

A spokeswoman for the FDA declined to comment on the meetings.

The CDC’s group, the Advisory Committee on Immunization Practices, or ACIP, scheduled a meeting for Nov. 23. That’s expected to be a pre-approval meeting for Covid-19 vaccines.

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