FDA approves Moderna mRNA flu vaccine for adults 50 and older
The FDA approved Moderna's first mRNA influenza vaccine for adults ages 50 to 64, with accelerated approval for adults 65 and older ahead of the 2026-2027 flu season. A phase 3 trial of about 40,000 people found about 27 percent fewer flu cases than with a standard flu shot.
The Food and Drug Administration has approved the first U.S. flu vaccine made with messenger RNA technology, manufacturer Moderna announced, according to Fox News.
The shot, built on the same mRNA platform used in COVID-19 vaccines, is fully approved for adults ages 50 to 64 ahead of the 2026-2027 flu season. For adults 65 and older, the agency granted accelerated approval, which allows use while Moderna finishes another study to confirm benefit in seniors.
Experts say mRNA vaccines can be updated faster when circulating flu strains change. Approval rested on a phase 3 trial of about 40,000 participants. The new vaccine reduced flu cases by about 27 percent compared with a standard flu vaccine, Fox News reported from the company announcement. No major safety concerns were identified in the trial. Short-term side effects such as arm pain, fatigue, headache, and fever were more common than with conventional shots but were generally mild and temporary.
Dr. Marc Siegel, Fox News senior medical analyst, said the product is not a universal vaccine. It is designed for rapid turnaround once yearly strains are identified. He said it was found to be roughly 25 to 30 percent more effective than the current flu vaccine and is aimed at protecting older adults.
Older adults carry most of the severe flu burden. During the 2024-2025 season, people 65 and older accounted for 57 percent of flu-related hospitalizations and 71 percent of deaths, according to CDC figures cited in the report. That season brought an estimated 51 million flu illnesses, about 710,000 hospitalizations, and about 45,000 deaths.
Earlier in the year the FDA initially declined to review Moderna's application over trial-design concerns, the Associated Press reported. Moderna disputed the move, and the agency later agreed to proceed. In June an independent FDA advisory committee concluded that benefits outweighed risks.
Moderna said the approval could lead to combination shots that cover more than one respiratory virus, including a flu and COVID combination aimed at a single seasonal dose.
Patients should check with their doctor or pharmacist about availability, insurance coverage, and how this option fits beside existing high-dose and adjuvanted flu vaccines for older adults.
Go Deeper
Who can get this vaccine?
It is fully approved for adults 50 to 64. Adults 65 and older have accelerated approval while Moderna completes a confirmatory study.
How much better was it than a standard flu shot?
In a phase 3 trial of about 40,000 people, it reduced flu cases by about 27 percent compared with a standard flu vaccine, according to the company announcement summarized by Fox News.
What side effects were reported?
Arm pain, fatigue, headache, and fever were more common than with conventional flu shots. They were generally mild and temporary, and the trial report cited no major safety concerns.
Why focus on older adults?
People 65 and older made up most flu hospitalizations and deaths in the 2024-2025 season, per CDC data. That is why new flu tools often target this age group first.
Will it replace the flu shot I usually get?
That depends on supply, clinic choice, and medical advice. High-dose and adjuvanted vaccines already exist for seniors. Ask your clinician which product is best for you this season.
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