US FDA’s Top Two Vaccine Officials Announce Surprise Retirements
Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.
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CBER Director Peter Marks told Janet Woodcock in an email that he thought reviewers were treating the BLA for the first fully approved COVID-19 vaccine as a conventional review or learning exercise.
The agency’s Vaccines and Related Biological Products Advisory Committee will consider simplifying and harmonizing the vaccine composition, as well as formalizing a system for likely annual US updates.
Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.