Just Ahead of Flu Season, FDA Approves First mRNA Vaccine for Older Adults

The Food and Drug Administration (FDA) has approved a new mRNA flu vaccine called mFLUSIVA for older adults, ahead of the 2026-2027 flu season. The vaccine, developed by Moderna, was found to be effective in preventing serious illness in people aged 50 to 64 in clinical trials. The FDA also granted accelerated approval for adults aged 65 and older, although more research is needed on this age group.

mFLUSIVA uses mRNA technology, similar to COVID-19 vaccines, which prompts the body to produce influenza antigens and trigger an immune response. This approach could potentially allow faster updates to match circulating strains. The vaccine was approved after a phase 3 clinical trial involving over 40,000 adults aged 50 and older in 11 countries, showing it was 26% more effective than a licensed standard-dose flu vaccine.

Health experts have expressed optimism about the new vaccine, stating it could benefit older adults who are at higher risk of serious complications from influenza. However, more research is needed to confirm its effectiveness in people aged 65 and older. The FDA's approval comes one year after HHS Secretary Robert F. Kennedy Jr. criticized mRNA vaccines, claiming they "failed to protect" against respiratory diseases such as COVID-19 and influenza.