The FDA plans to schedule consultations in early December to debate Covid-19 vaccines previous to doable approval
The Food and Drug Administration has asked a group of advisors to set aside three days in early December for possible meetings to discuss Covid-19 vaccines – an important step in the agency’s approval process, according to a person familiar with the plans.
The advisory group could be asked to weigh both Pfizer and Moderna vaccines, said the person who asked not to be named because the plans are not yet public.
The meetings, tentatively scheduled for December 8th, 9th, and 10th, would take place just weeks after both companies reported data from their Phase 3 studies showing that their vaccines were about 95% are effective in preventing cases of Covid-19.
On Wednesday morning, Pfizer and its partner BioNTech reported the final efficacy results of their study. They said they had reached the safety milestone required by the FDA and planned to submit their application to use the vaccine in an emergency within days.
Moderna is expected to reach this safety milestone soon as well. The FDA requires two months of safety surveillance after half of the study participants were fully vaccinated – two vaccination shots several weeks apart. The company announced Monday that it plans to seek approval from the FDA in the coming weeks.
The regulator is expected to take a swift decision on vaccines after the meetings of the group known as VRBPAC for the Advisory Committee on Vaccines and Related Biological Products. When the vaccines are given the green light, an advisory committee from the Centers for Disease Control and Prevention would meet to make recommendations on prioritization.
An FDA spokeswoman declined to comment on the meetings.
The CDC group, the Advisory Committee on Immunization Practices (ACIP), scheduled a meeting on November 23. It is expected to be a pre-approval meeting for Covid-19 vaccines.