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 two people familiar with the plans.
The meetings, tentatively scheduled for December 8-10, would take place just weeks after both companies reported data from their Phase 3 studies that showed their vaccines were about 95% effective in prevention Cases of Covid-19.
Wednesday morning Pfizer and his partner BioNTech reported final effectiveness Results According to their study, 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 shots several weeks apart. The Company said On Monday, the plan was to get FDA approval within a few weeks.
The regulator is expected to take a quick decision on the vaccines after the group known as meets VRBPAC, for the Advisory Committee on Vaccines and Related Biological Products. If the vaccines are given the green light, an advisory committee from the Centers for Disease Control and Prevention would make recommendations on prioritization.
An FDA spokeswoman declined to comment on the meetings.
The CDC group, the Advisory Committee on Immunization Practices (ACIP), planned a To meet This is expected to be a pre-approval meeting for Covid-19 vaccines.