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5d ago

FDA Advisers Unanimously Back Moderna’s mRNA Flu Vaccine

Unanimous advisory support advances the shot toward licensure; final FDA action is due by Aug. 5, with CDC coverage unsettled by ACIP’s inability to convene.

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FILE - A sign marks an entrance to a Moderna building in Cambridge, Mass., May 18, 2020. (AP Photo/Bill Sikes, File)prnto
A resident receives a Covid-19 booster shots at a vaccine clinic inside Trinity Evangelic Lutheran Church in Lansdale, Pa., on April 5, 2022.

Overview

  • Thursday’s 9–0 vote by the FDA’s Vaccines and Related Biological Products Advisory Committee said the benefits of Moderna’s mRNA flu vaccine outweigh its risks for people 50–64 and for those 65 and older.
  • Moderna’s Phase 3 Fluent trial enrolled about 40,000 adults 50 and up and showed roughly 26–27% relative efficacy versus a standard-dose flu shot in that group.
  • The panel recommended traditional approval for ages 50–64 and supported accelerated approval for 65+ with a required postmarketing effectiveness trial focused on older adults.
  • Advisers flagged higher reactogenicity—local reactions about 67.5% versus 32.1% and systemic reactions about 58.0% versus 32.4% compared with standard shots—as an acceptability issue that will need clear messaging.
  • Even with a favorable FDA decision, rollout could be delayed because CDC vaccine policy and insurer coverage depend on ACIP, which cannot currently meet due to a federal court injunction.