Overview
- The FDA granted traditional approval for people ages 50–64 and accelerated approval for those 65 and older, with Moderna required to run a postmarketing effectiveness study in the older group.
- A large phase III trial of about 40,700 adults found the mRNA vaccine reduced symptomatic influenza by about 26.6% overall and by about 27.4% in adults 65 and older compared with standard-dose vaccines.
- The trial also showed larger relative reductions in medically attended cases (33.7%) and in higher‑level care encounters including hospital visits (47.9%).
- Recipients of the mRNA vaccine reported substantially higher short‑term reactions such as injection‑site pain, fatigue, headache, and muscle aches while serious adverse events were rare and similar between groups.
- Moderna expects supply for the 2026–27 season, but CDC advisory committee recommendations and insurer coverage could be delayed because court action has prevented the panel from meeting after an earlier FDA review reversal and political controversy.