FDA approves first mRNA seasonal flu vaccine

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The US Food and Drug Administration has approved Moderna's mFlusiva, the world's first mRNA-based seasonal influenza vaccine, for adults aged 50 years and older, with full approval for ages 50–64 and accelerated approval for those 65 and above pending further studies. A Phase 3 trial of more than 40,000 adults found a 26.6% reduction in laboratory-confirmed influenza versus a standard licensed vaccine and stronger immune responses than Sanofi's high-dose vaccine in older adults. The approval highlights mRNA's potential for quicker design and production and could influence future influenza vaccine programs beyond the United States.

FDA approved Moderna's mFlusiva for adults aged 50 and older.