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COVID Vaccine BLA Review ‘Sprint’: Elevating Marks Role Could Have Drawbacks

 
• By Sarah Karlin-Smith

US FDA veterans offered varying opinions as to the benefits and risks of the CBER director taking on a more hands-on role in reviewing Pfizer’s COVID-19 vaccine. The move was called unusual, but not inappropriate; some said it should be monitored closely to ensure review staff’s judgements are not pushed aside.

sprinter
FDA is kicking off a sprint to finish reviewing Pfizer’s COVID-19 vaccine BLA. • Source: Alamy

Reports that US Food and Drug Administration’s Center for Biologic Evaluation and Research Director Peter Marks is assuming leadership of Pfizer Inc./BioNTech SE’s COVID-19 biologics license application raises some potential red flags the agency should be sure to handle carefully.

“I think it's great to have the center director engaged. And trying to help the process along, but I do...

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