Home / Health / Moderna's mRNA Flu Shot Approved by FDA
Moderna's mRNA Flu Shot Approved by FDA
6 Aug
Summary
- FDA approved Moderna's mFLUSIVA, the first mRNA flu vaccine.
- The vaccine is approved for adults aged 50 and older.
- mFLUSIVA is expected to be available for the 2026-27 flu season.
The U.S. Food and Drug Administration has granted approval to Moderna's mFLUSIVA, a novel seasonal flu vaccine that employs mRNA technology. This significant development makes mFLUSIVA the first influenza vaccine utilizing mRNA to receive FDA authorization.
Moderna stated that this approval underscores the continuing capability of their mRNA platform to tackle critical public health issues through scientific innovation. The vaccine has been approved for adults aged 50 and above.
The regulatory review process involved discussions leading to a revised approach after initial hesitations. Moderna revised its application to seek approval for adults aged 50 to 64 and accelerated approval for those 65 and older, also agreeing to an additional study for older adults.
Moderna anticipates that mFLUSIVA will be accessible for the 2026-27 flu season, offering a new option in influenza prevention.
