FDA Advisory Panel to Consider Pfizer/BioNTech Booster Shots

The FDA announced that it will hold an advisory committee meeting Sept. 17 to discuss the third booster for the Pfizer/BioNTech mRNA COVID-19 vaccine for people age 16 years and older.

The announcement comes 10 days after the Biden administration said it hoped to begin administering the shots mid-September (DID, Aug. 24). And the vaccine advisory panel meeting will be held just three days before the administration said it plans to begin administering shots to people in the general public who got their second shots eight months prior.

The administration’s announcement about beginning to give boosters on Sept. 20 reportedly rocked the FDA, which is also currently under huge pressure to approve the vaccine for kids under age 12. It’s far from clear that the government will be ready to begin giving approved booster shots to the public if the agency approval doesn’t come until Sept. 17.

“A transparent, thorough and objective review of the data by the FDA is critical so that the medical community and the public continue to have confidence in the safety and effectiveness of COVID-19 vaccines,” said Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, in a statement about the upcoming meeting. “The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner.”

Two top vaccine officials announced this week that they were leaving the FDA, and it’s been reported that Biden’s announcements of boosters for all by Sept. 20 is the main reason why. Marion Gruber, director of the FDA’s Office of Vaccines Research and Review (OVRR), who has been with the agency for 32 years, plans to retire on Oct. 31, while Phil Krause, deputy director of OVRR, who has served with the agency for more than 10 years, will depart in November (DID, Sept. 1).

The departures are also reportedly linked to concerns that the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices panel have taken key roles in what Gruber and Krause believe should solely be FDA decisions.

On Aug. 13, the FDA greenlighted the Pfizer/BioNTech booster shot for certain immunocompromised populations (DID, Aug. 16).

The agency is also looking at Moderna’s application for booster shot approval. — Suz Redfearn