Moderna’s mRNA Flu Vaccine Approved by FDA
The agency requires more data to prove efficacy for over 65s, but has licensed the first mRNA-based flu shot in the United States for those aged 50–64.
The U.S. Food and Drug Administration has approved Moderna’s mRNA vaccine, mFlusiva, for seasonal influenza in adults aged 50 and older. This marks the first FDA-licensed mRNA vaccine for seasonal flu. While granted traditional approval for ages 50-64 and accelerated approval for over-65s, Moderna must conduct further studies for the older group.
- FDA approves Moderna’s mFlusiva, the first mRNA vaccine for seasonal flu.
- Approved for adults aged 50-64 (traditional approval) and over-65s (accelerated approval).
- Moderna needs to provide more data on efficacy for the over-65 age group.
- A late-stage trial showed the shot was 26.5% more effective than a standard-dose flu vaccine.
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