The U.S. Food and Drug Administration on Wednesday approved Moderna's mFlusiva, the first influenza vaccine to use mRNA technology, clearing it for adults aged 50 and older ahead of the 2026–2027 respiratory virus season.
The agency granted full approval for adults 50 to 64, citing a late-stage trial of more than 40,000 participants across 11 countries that showed roughly 27% greater efficacy than a standard flu shot. For those 65 and older, the FDA issued an accelerated approval contingent on Moderna conducting an additional clinical trial. Moderna expects the vaccine to reach retailers within weeks.
The decision follows an unusual regulatory dispute in which the FDA initially declined to review the application before reversing course. The approval comes despite opposition from Health Secretary Robert F. Kennedy Jr., who has criticized mRNA technology and cut federal funding for related research. In June, an independent FDA advisory panel voted unanimously to recommend the vaccine's approval.