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Moderna (NASDAQ: MRNA) has received approval from the U.S. Food and Drug Administration (FDA) for its mRNA-based influenza vaccine, mFLUSIVA, for adults aged 50 and older. The approval marks a significant milestone for the biotechnology company, making mFLUSIVA its first approved mRNA flu vaccine and its fourth FDA-approved product in the United States. Globally, the vaccine becomes Moderna's fifth approved product.
The company plans to begin shipping mFLUSIVA to select retailers across the United States in the coming weeks, allowing availability ahead of the 2026–2027 respiratory virus season.
The FDA's decision follows a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee and is supported by results from a Phase 3 clinical trial involving 40,805 adults aged 50 years and older across 11 countries. The study demonstrated the vaccine's effectiveness while maintaining an acceptable safety profile, with researchers reporting no new safety concerns.
For adults aged 65 and above, the vaccine received accelerated approval based on immune response data from a separate U.S. trial that enrolled 2,992 participants. Moderna said it will conduct post-marketing confirmatory studies to further verify the vaccine's clinical benefits for this older age group, as required under the accelerated approval pathway.
Moderna CEO Stephane Bancel said the company's mRNA technology expands vaccination options for older adults, who face a higher risk of severe influenza and related complications. The company believes its mRNA platform can help improve protection against seasonal flu while supporting broader innovation in vaccine development.
Beyond the U.S., Moderna is seeking to expand the vaccine's global reach. Regulatory applications for mFLUSIVA are currently under review in the European Union, Canada, and Australia, with additional submissions planned later this year. If approved in these markets, the vaccine could strengthen Moderna's growing respiratory vaccine portfolio and reinforce its position in the global influenza vaccine market.
