Results of Friday’s FDA Advisory Committee Meeting
September 20, 2021
Last Friday, the FDA’s key advisory committee convened for an 8-hour meeting to discuss and vote on boosters for those 16+ years of age. 84% of committee members voted “no” on boosters for the general population, citing safety concerns and a lack of data on the reduction of transmission after a third dose. In an unexpected turn of events, the FDA advisory committee created and voted on a second question, as to whether the known and potential benefits outweigh the known and potential risks of the Pfizer Covid booster – at least 6 months after the primary series – for use in those 65+ and those at high risk of severe COVID-19. Panelists voted “yes” unanimously.
Since “high risk” can be broadly interpreted, many Americans who wish to be given a booster may be eligible. Additional doses for immunocompromised persons, including those with autoimmune disease who may not have developed sufficient antibodies after their primary vaccination series, are eligible for a COVID-19 booster dose.
The FDA typically follows the committee’s recommendations, but it is not mandatory that they do so. The FDA will most likely issue a decision this week, possibly before the CDC’s ACIP meeting on Wednesday. The CDC will develop vaccine policy based on the recommendations of the CDC advisory committee.