The US Food and Drug Administration has approved mFlusiva (mRNA-1010), the first messenger RNA influenza vaccine for use in the United States. The decision, announced on August 5, 2026, applies to adults aged 50 and older.
Adults aged 50–64 received full approval based on Phase 3 results showing the vaccine was 26.6% more effective than current influenza vaccines and met all safety thresholds. Reported side effects — including fatigue, headache and nausea — were in line with existing flu shots.
For people aged 65 and older, the FDA granted accelerated approval based on immune-response data. Continued access for this age group depends on an ongoing clinical trial assessing the vaccine's performance in that demographic.
Moderna stated it expects mFlusiva to be available for eligible adults during the 2026–2027 respiratory virus season. The vaccine uses the same mRNA platform as the company's widely administered COVID-19 shot.
The approval marks a shift for the FDA, which had previously been cautious about mRNA influenza vaccine research. It comes one year after the Department of Health and Human Services cut roughly $500 million in funding for 22 mRNA vaccine development projects.
Europe approved Moderna's combined COVID-19 and influenza vaccine, mCombriax, in April 2026, making mFlusiva the second mRNA flu vaccine authorized in a major regulatory jurisdiction.
mRNA technology allows faster adaptation to emerging flu strains compared with traditional egg-based or cell-based manufacturing, potentially enabling a more proactive response to seasonal mutations.
The initial US rollout will be limited to the 50-and-older population, leaving younger adults and children without access to the new vaccine for the upcoming season.
First mRNA flu vaccine has been approved for US adults
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