FDA Grants Approval to Moderna's mRNA Flu Vaccine for Adults 50+
The U.S. FDA has approved Moderna's mRNA-based seasonal flu vaccine, mFLUSIVA, for adults aged 50 and older, marking the first such approval for an influenza vaccine using this technology.
The U.S. Food and Drug Administration approved Moderna's mRNA seasonal flu vaccine, named mFLUSIVA, for adults 50 years and older, making it the first influenza vaccine employing messenger RNA technology to receive FDA clearance. The agency had initially declined to review the application but reversed its stance after Moderna submitted a revised submission and regulatory approach.
Moderna said the vaccine demonstrated greater effectiveness than a standard flu shot in a 40,000-participant trial involving adults aged 50 and older. The FDA had previously raised concerns that the trial did not include a comparator vaccine recommended for people 65 and older. In response, Moderna amended its filing to seek full approval for ages 50-64 and accelerated approval for those 65 and older, and agreed to conduct an additional study in the older age group.
"This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation," the company said in a statement.
The FDA's decision comes despite criticism of mRNA technology from Health and Human Services officials. Moderna expects to make mFLUSIVA available for the 2026-27 flu season.