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7h ago

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

The agency granted full approval for ages 50–64 and accelerated approval for 65+ with required confirmatory studies; broader access will depend on CDC recommendations and buying cycles.

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)
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
People pose with syringe with needle in front of displayed Moderna logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo
The Moderna Inc. facility in Laval, Quebec, Canada, on Friday, Sept. 19, 2025. Moderna is producing made-in-Canada Covid-19 vaccines at plants in Laval and Cambridge, Ontario, Globe & Mail reports.

Overview

  • The FDA approved Moderna’s mFlusiva on Wednesday for people 50 and older, issuing full approval for ages 50–64 and accelerated approval for those 65 and above pending a post‑marketing trial to confirm benefit in seniors.
  • The decision was based on a late‑stage trial of more than 40,000 adults that found mFlusiva reduced laboratory‑confirmed flu by about 26.6–27% versus a licensed standard‑dose vaccine.
  • Trial participants who received mFlusiva reported higher rates of common reactions such as injection‑site pain, fatigue and headache, and a small number of serious events were judged related in rare cases.
  • Regulators first refused Moderna’s application earlier this year before reversing course, the agency’s independent advisory panel later voted unanimously to recommend approval, and political decisions at HHS previously cut federal mRNA funding.
  • Moderna expects limited availability for the 2026–27 season but wide use, insurer coverage and public distribution will depend on CDC/ACIP guidance, procurement timing and the company winning future contracting cycles, so meaningful U.S. revenue is not expected until mid‑2027.