The vaccine momentum continues as the testing success of Pfizer/BioNTech and Moderna has pushed up the timeline in the fight for some COVID-19 relief.
The Food and Drug Administration reportedly wants to clear three days, tentatively Dec. 8-10, for meetings with an advisory group, likely to discuss coronavirus vaccines. It’s an important hurdle to clear en route to vaccine authorization, according to two people familiar with the plans.
A CNBC story Wednesday said the advisory group may be asked to speak about Pfizer and Moderna’s vaccines, say two sources with knowledge of the situation. The sources asked not to be named because the plans aren’t yet public, and a spokeswoman for the FDA declined to comment on the meetings.
Wednesday morning, Pfizer and partner BioNTech announced final results of a Phase 3 trial, concluding their vaccine is 95% effective. That’s better than the 90% result initially estimated.
Pfizer and BioNTech planned to submit their vaccine application for emergency use within days and expect to produce 50-million vaccine doses for 2020, and up to 1.3 billion by the end of 2021.
Moderna, whose vaccine was 94.5% effective, is expected to also pass the screening requirements and be part of the meeting discussion. The company said Monday it planned to seek FDA authorization within weeks.
A relatively quick decision is expected following the planned meetings of the group, known as VRBPAC, for Vaccines and Related Biological Products Advisory Committee. If this group gives the OK to move forward, a CDD advisory group would make recommendations on prioritization.
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 vaccines.