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FDA Advisers Back Moderna's mRNA Flu Shot for Adults 50 and Older

Unanimous advisory support moves the application toward an FDA decision by Aug. 5 with senior use contingent on a large confirmatory trial.

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A resident receives a Covid-19 booster shots at a vaccine clinic inside Trinity Evangelic Lutheran Church in Lansdale, Pa., on April 5, 2022.
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Overview

  • A federal vaccine advisory panel voted unanimously on June 18 that Moderna’s mFlusiva has benefits that outweigh its risks for people 50 and older, a key step before the FDA’s final decision by Aug. 5.
  • A pivotal trial of about 40,000 adults showed the mRNA shot cut confirmed flu cases by roughly 27% compared with a routinely used standard-dose vaccine in the 50–64 age group.
  • Moderna is seeking full approval for ages 50–64 and accelerated approval for those 65 and older, and the company has committed to a roughly 400,000-person post-authorization study to confirm benefit in seniors.
  • FDA reviewers and advisers flagged gaps that remain, including that the trials cover a single flu season, excluded very frail and immunocompromised people, and that the mRNA shot causes more short-term side effects than some existing flu vaccines.
  • If cleared, mFlusiva would be the first U.S. seasonal flu vaccine made with mRNA technology, which can be manufactured faster for better strain matching and could change Moderna’s commercial prospects and competition with established vaccine makers.