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FDA Schedules Vaccines Panel On COVID Boosters As Questions Linger About Data Adequacy

 
• By Sarah Karlin-Smith

VRBPAC could help restore some confidence in any booster decision after White House moved ahead of FDA and CDC, but without hard outcomes data and no proven immune correlate of protection, support for Pfizer’s sBLA at the 17 September advisory committee meeting seems far from guaranteed.

third vaccine shot
FDA is moving fast to get Pfizer’s booster sBLA to an advisory committee just weeks after receiving the application • Source: Alamy

The US Food and Drug Administration is speeding forward with review of Pfizer Inc./BioNTech SE’s booster application for the companies COVID-19 vaccine Comirnaty. The agency announced a 17 September advisory committee meeting to review the supplemental biologics application even as questions linger about whether the data at hand is sufficient for clearing booster shots.

The Vaccines and Related Biologics Products Advisory Committee meeting is on a Friday, the last business day before the Biden administration’s target date for beginning its booster campaign on 20 September

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