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FDA Reverses Course To Review Moderna’s mRNA Flu Shot Under Split Pathway

The reversal follows a rare refusal-to-file over the trial comparator for seniors, with a decision due August 5.

Illustration by Noah Hickey/The Dispatch (Photos by Kevin Dietsch and Anna Moneymaker/Getty Images).
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Overview

  • Moderna’s amended filing seeks full approval for adults 50–64 and accelerated approval for those 65 and older, with a required post‑marketing study in seniors.
  • The FDA’s initial refusal-to-file, signed by CBER director Vinay Prasad, said the Phase 3 control did not reflect the best available standard for older adults; no safety or efficacy issues were cited by the company.
  • The agency has accepted the revised application and set a target decision date of August 5, 2026, positioning the shot for potential use in the 2026–2027 flu season if approved.
  • Moderna reported its vaccine was more effective than a standard comparator in adults 50 and older, and the program remains under review by regulators in Europe, Canada and Australia.
  • The high-profile dispute unfolded as HHS under Secretary Robert F. Kennedy Jr. scaled back mRNA initiatives, including canceling roughly $500 million in federal contracts, drawing industry attention to vaccine policy shifts.