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17h ago

FDA Approves Moderna’s mFlusiva for Adults 50 and Older

The authorization brings the first U.S.‑licensed mRNA seasonal flu vaccine but its public rollout is uncertain because the CDC advisory panel cannot meet to set formal recommendations.

Moderna's mRNA-based flu vaccine, mFLUSIVA, is seen in an image provided by the company on Thursday, Aug. 6, 2026. The FDA granted approval a day earlier for the vaccine’s use in all adults 50 and older. (Courtesy of Moderna)
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

Overview

  • The FDA approved mFlusiva on Wednesday for people aged 50 and older, granting traditional approval for ages 50–64 and accelerated approval for ages 65 and up with a required post‑licensure (Phase 4) trial for the older group.
  • Regulatory approval was based on a late‑stage trial of more than 40,000 adults that showed about a 26.6–27% higher efficacy versus a licensed standard‑dose flu vaccine in people 50 and older.
  • Trial data showed higher rates of short‑term side effects with mFlusiva, including injection‑site pain, fatigue and headache, and a small number of serious events are being reviewed.
  • Moderna says it expects some doses for the 2026–2027 season, but the CDC’s Advisory Committee on Immunization Practices cannot meet because of a federal court block, which could delay formal CDC recommendations and insurer coverage.
  • The approval caps an unusual regulatory fight that included an early refusal‑to‑file, a later agency reversal and leadership turnover, and it signals wider potential for faster mRNA flu production and quicker strain updates in future seasons.