FDA Approves mFlusiva, the First mRNA-Based Influenza Vaccine
- The FDA has approved mFlusiva, the first mRNA-based influenza vaccine developed by Moderna, specifically targeting adults aged 50 and older.
- The regulatory strategy includes full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, pending a postmarketing study using a high-dose comparator.
- This approval follows a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee in June 2026.
- The new vaccine aims to address the significant public health challenge of influenza among seniors and is expected to be available for the 2026 to 2027 flu season.
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