The Food and Drug Administration (FDA) has approved Moderna’s first mRNA-based seasonal flu vaccine, called mFLUSIVA.
The approval comes after the FDA initially refused to review the company’s application, an uncommon move that was later reversed following public backlash, according to The New York Times.
It marks a major step for the company’s vaccine technology beyond COVID-19. The shot will be available for adults aged 50 and older during the 2026-27 flu season.
In a late-stage clinical trial, the vaccine reduced confirmed flu cases by 27% compared with the current standard flu shot in people aged 50 to 64. Most side effects were mild, lasted no more than two days, and had a safety profile similar to existing vaccines.
Moderna will continue studying the vaccine in adults aged 65 and older.
The approval comes despite Health Secretary Robert F. Kennedy Jr.’s criticism of mRNA technology. He canceled $500 million in mRNA research funding last year and has questioned its safety, a view that contrasts with the broad consensus among doctors.
Experts say mRNA technology could speed up flu vaccine production and better match circulating virus strains.