FDA approves Moderna mRNA flu vaccine for adults 50 and older

The Food and Drug Administration approved Moderna's mRNA seasonal influenza vaccine, mFLUSIVA, on Wednesday for use in adults aged 50 and older. The vaccine is expected to be available for the 2026-2027 respiratory illness season.

In a clinical trial involving participants aged 50 to 64, the mRNA vaccine led to 27% fewer confirmed flu cases than the current standard vaccine. The safety profile was similar between the two vaccines, though more recipients of the mRNA vaccine reported side effects, which were mostly mild and lasted two days or less.

For adults 65 and older, a high-dose flu vaccine is currently recommended. Moderna said it will collect data this winter on how mFLUSIVA performs compared to the high-dose vaccine and submit those results to the FDA to determine whether the approval should be extended to that age group.

Earlier this year, the FDA initially declined to review Moderna's application. The agency reversed that decision after the company committed to conducting a post-market study once the vaccine became available.

The approval comes amid public criticism of mRNA vaccine technology from Health Secretary Robert F. Kennedy Jr., who last year canceled at least $500 million in federally funded mRNA vaccine development. Infectious disease experts and vaccinologists have maintained that the mRNA platform is safe.

Vaccine specialists have noted that the mRNA platform can expedite production and allow vaccines to better match circulating virus strains because they can be manufactured more quickly than traditional egg-based methods.

The Centers for Disease Control and Prevention recommends annual flu vaccination for everyone over six months of age, typically before the end of October, to reduce the risk of severe illness, hospitalization, and death.

This is a developing story.