FDA reverses refusal to review Moderna’s mRNA flu vaccine

The Food and Drug Administration backtracked on its earlier refusal to review Moderna’s mRNA flu vaccine and moved to publicly defend its handling of the matter. Moderna had said the agency rejected its request to submit an application despite late-stage trials showing the shot was safe and effective, and Commissioner Marty Makary suggested the vaccine might ultimately be approved, calling the rejection “part of a conversation that occurs with all drug makers.” The agency’s initial decision was made by Dr.

Vinay Prasad, who overrode staff recommendations and blocked the review, a move that divided staff and put him at odds with Dr. David Kaslow.

United States

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