F.D.A. Refuses to Review Moderna Flu Vaccine

Moderna said the Food and Drug Administration notified the company that the agency would not review its mRNA flu vaccine. Dr. Vinay Prasad, the agency’s top vaccine regulator, rejected the application on the grounds that Moderna had compared its experimental shot against Fluarix Quadrivalent, a GSK product the agency did not consider the best-available standard of care.

The company enrolled 41,000 people in trials aimed at adults 50 and older and concluded its vaccine was superior to GSK’s product. Moderna said it received a "refuse to file" letter and that the agency did not cite specific safety or effectiveness concerns; a paper by company scientists last year reported the vaccine was safe and produced strong immune responses against A and B strains, with stronger results against A strains.

Stephen Hoge, Moderna’s president, said the vaccine had been designed to be tailored for a single nation and that the F.D.A. had earlier indicated support for the study plan.

United States

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