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

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

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