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.
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Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.
A third shot of COVID-19 vaccine may be recommended for Americans soon, but the CDC says the best defense against the pandemic in the US includes ensuring the entire world gets the primary series.
Some experts argue full FDA approval will help boost vaccination rates that are waning, but others want the agency to mandate studies in special populations and gather other data before making a final decision.