Monday, August 17, 2026
FDA approves Moderna's mFlusiva, the first mRNA flu vaccine
The FDA approved Moderna's mFlusiva on August 5, the first influenza vaccine built on mRNA technology, granting standard approval for adults 50 to 64 and accelerated approval for those 65 and older pending a postmarketing study. In the Phase 3 trial, mFlusiva showed about 27% higher relative efficacy against confirmed influenza-like illness than a standard-dose comparator, and Moderna expects it available in time for the 2026-2027 flu season, becoming the company's fourth approved respiratory product.
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