FDA panel unanimously recommends Moderna mRNA flu vaccine

A first-of-its-kind flu vaccine moved a significant step closer to the U.S. market on Thursday, June 18, 2026, as a panel of independent advisers to the Food and Drug Administration unanimously recommended its approval for older adults. The vaccine, developed by Moderna and called mFlusiva, uses the same mRNA technology that was pivotal in COVID-19 vaccines.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 9-0 that the vaccine’s benefits outweigh its risks for two age groups: adults 50 to 64, and those 65 and older. The FDA will consider this recommendation and is expected to make a final decision by early August, ahead of the winter flu season.

The panel’s endorsement followed a review of clinical trial data. In a large study of 40,000 people aged 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared to a standard-dose flu shot. A smaller study in people 65 and older showed the shot generated a strong protective immune response comparable to a high-dose flu vaccine already recommended for that age group. FDA staff reviewers noted no major safety deficiencies, though the vaccine did cause temporary reactions like injection-site...