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# Califf Says No Panel Will Review Covid Boosters
- URL: https://www.fdaweb.com/califf-says-no-panel-will-review-covid-boosters/
- Published: 2022-08-25T12:00:00.000Z
- Updated: 2026-09-14T17:57:15.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152597

FDA commissioner **Robert Califf** says there will not be any advisory committee meeting to review recent submissions from Pfizer/BioNTech and Moderna that seek emergency use authorizations for new Covid-19 booster vaccines. In an 8/25 Twitter post, Califf said an “extensive discussion” was held in June by the agency’s vaccines advisory committee, which “voted overwhelmingly to include an omicron component in Covid-19 boosters. FDA has no new questions that warrant committee input.”

Califf said FDA will rely on the totality of the available evidence in making a decision on the EUAs, including: Clinical trial data from other bivalent mRNA COVID-19 boosters; real-world evidence from current Covid-19 vaccines administered to millions of people; and Non-clinical data for the bivalent BA.4/5 booster vaccines.

“Bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients,” he said. “FDA has extensive experience with reviewing strain changes in vaccines, as is done with the annual flu vaccine.”

It appears the CDC is expecting a positive agency decision on the boosters as early as next week. CDC’s Advisory Committee on Immunization Practices is already scheduled to convene meetings on 9/1-2 to review the boosters, after which CDC director **Rochelle Walensky** must sign off on the updated boosters before they can be administered to the public