The U.S. Food and Drug Administration has approved Moderna’s mFlusiva, the first flu vaccine built on mRNA technology — the same platform that powered COVID-19 shots.
Announced August 5, 2026, the vaccine received standard approval for adults aged 50 to 64 and accelerated approval for adults 65 and older, with a post-licensure Phase 4 trial required to confirm benefit in the oldest group. In its pivotal study, mFlusiva reduced test-confirmed influenza by 27% compared with a standard-dose flu vaccine in people aged 50 to 64. Safety was broadly similar, though the mRNA shot caused somewhat more side effects — mostly mild and lasting a day or two.
Why mRNA matters for flu
Traditional flu vaccines are grown in eggs, a months-long process that forces manufacturers to guess each year’s dominant strains far in advance. mRNA vaccines can be made faster, allowing strain choices closer to flu season and potentially better matches — and the platform could speed the licensing of pandemic-flu vaccines in a future outbreak.
A bumpy path, and what’s next
The approval capped an uneven review: the FDA initially declined to consider the application in February 2026, then reversed course a week later, and an expert advisory panel voted unanimously in favor in June. “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” Moderna’s CEO said. The company plans to seek approval in the EU, Canada, Australia and other countries.