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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.

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US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
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More from Agency Leadership

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.

US FDA Staff’s Union President Calls For More Support From Industry

 
• By Sarah Karlin-Smith

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.