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68811424 moderna says fda advisory committee votes in favor of investigational mrna flu vaccine 020
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Executive Summary
AI-generatedModerna announced that the FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended approving MFLUSIVA, its investigational mRNA influenza vaccine. The committee voted 9-0, finding that the benefits of the vaccine outweigh the risks for adults aged 50 through 64 and those 65 and older. The FDA is scheduled to make its final decision on August 5, 2026.
Key Insights
- MFLUSIVA (mRNA-1010) is an investigational mRNA vaccine designed for preventing influenza caused by subtypes A and B.
- The advisory committee determined that the benefits of MFLUSIVA outweigh its risks in older adults, specifically those 50+ years old.
- Moderna has received regulatory review acceptance in multiple regions, including the US, EU, Canada, and Australia.
- The company is scheduled to receive a PDUFA goal date from the U.S. FDA on August 5, 2026.
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