U.S. FDA approves first mRNA flu shot from Moderna
The U.S. FDA has approved Moderna's mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older. This marks the first time mRNA technology has been authorized for a seasonal flu shot, though commercial impact is not expected until 2027.
Why it matters
This approval validates the potential of mRNA technology beyond COVID-19 and signals a shift in how seasonal influenza vaccines may be developed and updated in the future.
The U.S. Food and Drug Administration has approved Moderna’s flu vaccine for people aged 50 and older, the company said on Wednesday (August 5, 2026), marking the first approval of a messenger RNA-based vaccine for seasonal flu.
The shot, mFlusiva, was given a traditional approval for adults aged 50 to 64, and an accelerated approval for those 65 years and older.
Moderna has agreed to run an additional study and submit more data in adults 65 and older to confirm the vaccine’s benefit in that age group.
“Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” Moderna said in a statement.
The approval was based on data from a late-stage trial involving more than 40,000 adults aged 50 and older, which showed the shot was 26.6% more effective than a licensed standard-dose flu vaccine.
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