FDA approves Moderna's mRNA seasonal flu vaccine

Moderna was seeking approval for the vaccine's use in adults over 50.

The Food and Drug Administration approved Moderna's mRNA seasonal flu vaccine on Wednesday.

The vaccine, mFLUSIVA, is expected to be available for people 50 and older for the 2026-2027 respiratory illness season.

"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation," Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement.

In a clinical trial for people aged 50 to 64, the mRNA vaccine led to 27% fewer confirmed flu cases than the current standard vaccine. The safety profile for Moderna’s vaccine and the current standard was about the same, but more people taking the mRNA vaccine reported side effects; those were mostly mild and lasted two days or less.

For people 65 and older, a high-dose vaccine is currently recommended. Moderna said it will keep data this winter on how mFlusiva does compared to the current high-dose vaccine and submit that to the FDA to see if the vaccine remains approved for that population.

Earlier this year, the FDA announced it would not review Moderna's application for the vaccine. However, the agency backtracked and agreed to review the shot after Moderna promised to conduct another study after the shot became available on the market.

Health Secretary Robert F. Kennedy Jr. has been vocal about his disapproval of the mRNA vaccine platform. Last year, the Department of Health and Human Services canceled at least $500 million of federally funded mRNA vaccine development .

In a press release announcing the cancellation of mRNA vaccine funding , Kennedy said that funding was going towards "safer, broader vaccine platforms that remain effective even as viruses mutate," despite infectious disease experts and vaccinologists saying the mRNA platform is safe. Kennedy also falsely claimed mRNA vaccines can prolong pandemics.

Vaccine specialists have emphasized that using the mRNA vaccine platform would help expedite production of shots and allow vaccines to better match currently circulating strains of viruses, because they can be produced quicker than the traditional way.

The flu vaccine is currently recommended for everyone over the age of 6 months by the Centers for Disease Control and Prevention .

It is typically recommended to receive the shot before the end of October. The vaccine helps reduce the risk of severe illness, including hospitalization and death.

This is a developing story. Please check back for updates.

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