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 two people familiar with the plans.
The meetings, tentatively set for Dec. 8-10, would come just weeks after both companies reported data from their phase three trials showing their vaccines are about 95% effective in preventing cases of Covid-19.
Wednesday morning, Pfizer and its partner BioNTech reported final efficacy results from their study, saying they had 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 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 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 preapproval meeting for Covid-19 vaccines.