The U.S. Food and Drug Administration’s vaccine advisory panel has approved Moderna’s new flu vaccine, mFlusiva (mRNA-1010), for adults aged 50 to 64 and those 65 years and older. Both age groups received a unanimous 9–0 vote in favor of the approval during the committee’s review meeting.

The panel examined Moderna’s efficacy and safety data, noting the vaccine’s potential to address limitations in current influenza vaccination approaches. Rituparna Das, M.D., Ph.D., Senior Vice President of Clinical Development for Infectious and Rare Diseases at Moderna, highlighted that mRNA-1010 avoids egg-based adaptation processes typically used in traditional flu vaccines, enabling faster production cycles and more precise alignment with circulating viral strains.

The approval follows discussions about the vaccine’s application in vulnerable populations. FDA reviewer Dr. Timothy Brennan indicated the agency remains open to early adoption for older adults before the upcoming flu season, though further studies are needed for frail seniors or individuals with compromised immune systems. Moderna plans a pivotal trial involving 400,000 participants aged 65 and older over two flu seasons, comparing mRNA-1010 against standard senior flu vaccines.

Safety data from Moderna’s trials showed no major adverse events but reported more frequent temporary reactions—such as injection-site pain, fever, headache, fatigue, and body aches—compared to conventional flu shots. Dr. Hayley Gans, a Stanford Medicine pediatrician and FDA adviser, emphasized these responses signal an active immune system.

The approval coincides with ongoing scrutiny of mRNA vaccine technology. Earlier this year, Moderna faced criticism when a top FDA official blocked its initial application for the shot, stating it should have been compared to high-dose flu vaccines for seniors rather than standard formulations. The controversy occurred under heightened regulatory oversight by Health Secretary Robert F. Kennedy Jr.