FDA Approves mFlusiva, First mRNA Flu Vaccine


The U.S. Food and Drug Administration (FDA) has approved the first mRNA flu vaccine in the United States, giving adults ages 50 and up a new option for the 2026–2027 flu season.

The vaccine, called mFlusiva, received full approval for adults ages 50 to 64 and accelerated approval for adults 65 and older (allowing people in this age group to get the vaccine while the company that makes mFlusiva, Moderna, completes an additional study to confirm its clinical benefit in this age group).

“This is really significant,” says Paul Pottinger, MD, director of the Infectious Diseases and Tropical Medicine Clinic at UW Medical Center in Seattle, and cohost of the travel health podcast Germ & Worm. “It gives us not only a new choice, but also a more nimble, responsive way to help prevent flu,” he says.

Moderna is studying mFlusiva in younger age groups, but more data are needed before the FDA could expand its approval, says Dr. Pottinger.



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