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University of Nebraska Medical Center

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

NYT

The vaccine maker’s shots involve the successful Covid vaccines’ RNA technology. Health Secretary Robert F. Kennedy Jr. has broadly rejected it, canceling millions of dollars in research projects. The vaccine maker Moderna said on Tuesday that the Food and Drug Administration had notified the company that the agency would not review its mRNA flu vaccine, the latest sign of federal health policy that has become hostile to vaccine development.

Dr. Vinay Prasad, the agency’s top vaccine regulator, rejected the company’s application for approval over a concern that Moderna’s clinical trial had compared its experimental vaccine against a product the agency did not consider the best on the market. People in the comparison group received Fluarix Quadrivalent, a flu vaccine sold by GSK.

Moderna had spent years and hundreds of millions of dollars testing its flu vaccine, enrolling 41,000 people and aimed at a market of adults ages 50 and older. The company concluded that its shot was superior to GSK’s product.

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