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.
The moves to overrule staff and reject the application are the latest instances of Prasad subjecting vaccines to harsher scrutiny. Vaccine skepticism is seeping into the FDA from the top, as health secretary Robert F. Kennedy Jr. is a known vaccine critic. Prasad and another top official, Tracy Beth Høeg, have wrested control of vaccine surveillance from civil servants as well.
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