FDA clears Moderna’s first mRNA flu shot for adults 50 and older

The Food and Drug Administration approved Moderna’s seasonal influenza vaccine mFLUSIVA for adults 50 and older, giving the company its first cleared mRNA flu shot. Moderna said the vaccine is expected to be available for the 2026-27 respiratory virus season. In a clinical trial of adults ages 50 to 64, the vaccine resulted in 27% fewer confirmed flu cases than a current standard flu shot. The safety profile was broadly similar, though more recipients reported side effects that were mostly mild and lasted two days or less. For adults 65 and older, a high-dose flu vaccine is currently recommended. Moderna said it will gather data this winter comparing mFLUSIVA with that higher-dose shot and submit the results to the FDA.