WASHINGTON — Top Food and Drug Administration official Vinay Prasad overruled the agency’s reviewers when he refused to accept Moderna’s application for a new influenza vaccine, STAT has learned.
Three agency officials familiar with the matter told STAT that the team of career scientists was ready to review Moderna’s application, and that David Kaslow, the head of the vaccine office, wrote a detailed memo explaining why the FDA should embark on the review.
Health and Human Services Department spokesman Andrew Nixon said, “there was a diverse set of conclusions among the review team.”
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