Overview
- The FDA’s Vaccines and Related Biological Products Advisory Committee voted 9–0 on June 18 that the benefits of Moderna’s mRNA flu vaccine outweigh its risks for adults 50–64 and for those 65 and older.
- A large phase III trial of about 40,000 people 50 and older found the mRNA shot reduced symptomatic flu by roughly 26.6–27.4% versus a standard-dose vaccine, and a smaller study showed strong immune responses in people 65 and up.
- Trial data showed higher short-term local and systemic reactions with the mRNA vaccine (for example, injection-site and flu-like symptoms) but no new serious safety signals, raising questions about acceptability and messaging.
- Moderna is seeking traditional approval for ages 50–64 and accelerated approval for those 65+, with a committed post-approval effectiveness study in older adults; the FDA set an internal target decision date of Aug. 5.
- Practical rollout remains uncertain because a rare February refuse-to-file episode and subsequent FDA leadership turnover have clouded the review, and the CDC advisory panel that would set formal recommendation and coverage is blocked by a federal court order.