The Food and Drug Administration on Wednesday approved the United States' first flu shot that uses mRNA technology: mFlusiva, from drugmaker Moderna, NBC News reported. The approval covers adults 50 to 64 under a traditional approval and adults 65 and older under an accelerated approval, on the condition that Moderna run an additional clinical trial in the older group. In a late-stage trial of more than 40,000 adults across 11 countries, mFlusiva was found to be about 27% more effective than a standard flu shot, with a relative vaccine efficacy of 26.6%.
A Turbulent Path to Approval
The approval caps a fraught regulatory journey. The FDA initially refused to review Moderna's application in February, issuing a rare refuse-to-file letter over the trial's comparator — a standard-dose flu shot, rather than the high-dose vaccine the CDC recommends for adults 65 and older — before reversing course a week later. In June, the FDA's independent vaccine advisory committee voted unanimously to recommend approval. The vaccine is the fifth mRNA product approved in the United States, joining Moderna's two COVID-19 shots and its RSV vaccine.
Political Headwinds
Health and Human Services Secretary Robert F. Kennedy Jr. has long claimed mRNA technology poses a higher risk profile than traditional vaccines, and his department canceled $500 million in federally funded mRNA contracts in August 2025. An HHS spokesperson said the vaccine is entering the market with some of the strongest post-market study commitments the FDA has required, particularly for people 65 and older.
Faster Shots for Fast-Mutating Viruses
Traditional flu vaccines must be manufactured six months in advance of flu season, based on predictions that can fall short; mRNA vaccines take just two to three months to produce, allowing shots to be retargeted to circulating strains. Moderna says mFlusiva will be available for this fall's flu season, and a combination flu-COVID mRNA vaccine was approved by the European Union in April.
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