FDA Reverses Decision and Agrees To Review Moderna's Flu Vaccine

The Food and Drug Administration has reversed its decision on Moderna's flu vaccine and has agreed to review it for possible approval, Moderna announced on Wednesday. From a report: Last week, the agency rejected Moderna's application for review of a new flu vaccine, saying the company's research design was flawed. But in subsequent discussions the company said that the agency had relented and agreed to begin a review. Moderna said it split its application for the flu vaccine based on age, seeking a traditional approval for people 50 to 64 years old, and accelerated approval for those 65 and older. The company also said it agreed to conduct an additional study among those 65 and older once the vaccine reached the market. Moderna said on Wednesday that the F.D.A. set a deadline of August to decide whether to approve the vaccine. If it is authorized, it would be available for those older adults in the flu season that begins later this year. The vaccine uses messenger RNA technology, which Health Secretary Robert F. Kennedy Jr. has repeatedly criticized as unsafe and ineffective. The mRNA approach, which instructs the body to produce a fragment of a virus that sets off an immune response, was widely successful in Covid vaccines and is considered generally safe by public health experts and scientists.

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