F.D.A. Agrees to Review Moderna's mRNA Flu Vaccine After Reversal

The Food and Drug Administration has reversed its earlier decision and agreed to review Moderna’s flu vaccine that uses messenger RNA technology. The agency had rejected the company’s application last week, saying the research design was flawed, but accepted the submission after further discussions.

Moderna split its application by age group, seeking traditional approval for people 50 to 64 and accelerated approval for those 65 and older, and agreed to conduct an additional study among the older group once the vaccine reaches the market. The F.D.A. set an August deadline to decide whether to approve the vaccine; if authorized it would be available to older adults in the flu season that begins later this year.

The vaccine relies on mRNA, an approach Health Secretary Robert F. Kennedy Jr. has criticized as unsafe and ineffective, even though public health experts say the mRNA method, which proved widely successful in Covid vaccines, is generally safe.

United States

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