A top US Food and Drug Administration official was frustrated with the pace of the review of Pfizer Inc./BioNTech SE’s COVID-19 vaccine Comirnaty in 2021, and appeared to push for the application to be approved several weeks earlier than staff wanted, agency emails reveal.
US FDA’s Marks Was Frustrated About Slow Completion Of 2021 Comirnaty Review
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.
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