Pauses to coronavirus drug trials give 'reassurance'

FDA to plan December meetings ahead of potential authorization

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.The meetings, tentatively set for Dec. 8, 9 and 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’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.

Leave a Comment

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Scroll to Top
%d bloggers like this: