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FDA Approves Moderna’s First mRNA Flu Vaccine for Adults 50 and Older

The agency granted a traditional license for ages 50–64 and an accelerated approval for 65+ that requires a post‑approval Phase 4 trial.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
gloved hands draw fluid from a vaccine vial into a syringe
Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Overview

  • The FDA announced on Aug. 5 that it approved Moderna’s mFlusiva for people 50 and older, giving full approval to ages 50–64 and accelerated approval to adults 65 and up.
  • Approval rested on a late‑stage trial of about 40,000 participants that found mFlusiva reduced confirmed flu cases by roughly 26.6%–27% versus a licensed standard‑dose vaccine.
  • Trial participants who received mFlusiva reported more short‑lived side effects such as injection‑site pain, fatigue and headache, while serious vaccine‑related events were rare.
  • Moderna must run a post‑licensure Phase 4 study to confirm clinical benefit in the 65+ group using high‑dose or adjuvanted vaccines as comparators as a condition of accelerated approval.
  • Practical rollout may be limited this season because pharmacy contracting was largely set, the CDC’s advisory committee is not fully operational which could delay formal recommendations and insurer coverage, and broader regulatory reviews continue in the EU, Canada and Australia.