FDA Reverses Course to Review Moderna mRNA Flu Vaccine
- Feb 18
- 2 min read
In a sudden shift that has revitalized investor confidence, the U.S. Food and Drug Administration (FDA) has agreed to review Moderna’s experimental mRNA influenza vaccine, overturning a surprising rejection issued only two weeks ago. The reversal follows a "constructive" meeting between the regulator and the pharmaceutical giant, ending a public dispute that had briefly clouded the future of mRNA technology in the U.S..
The initial friction began when the FDA refused to even accept Moderna’s application, an "extraordinary move" usually reserved for obvious filing deficiencies. The regulator argued that the company’s clinical trials were not rigorous enough because they compared the experimental shot to a standard flu vaccine rather than the "best-available standard of care"—typically higher-dose vaccines—recommended for older adults. Moderna countered that the trial design had been previously signed off by agency leadership.
To break the deadlock, Moderna proposed a revised regulatory approach that splits the approval pathways by age. Under the new plan, the company is seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. As a condition for the accelerated path, Moderna will conduct a post-marketing study using real-world evidence to confirm the vaccine's efficacy in the eldest population, avoiding the need for a new, massive clinical trial.
This regulatory breakthrough is a critical milestone for Moderna as it seeks to diversify its business beyond COVID-19 immunizations, with hopes to break even by 2028. The decision also arrives amidst a shifting political landscape, as Health Secretary Robert F. Kennedy Jr. has been a vocal critic of the mRNA technology used in these shots.
Despite the previous tension, FDA Commissioner Marty Makary recently characterized the initial rejection as part of a standard "dialogue" between the agency and the developer. Moderna CEO Stéphane Bancel expressed optimism, stating that pending approval, the company looks forward to providing "America’s seniors access to a new option to protect themselves against flu" later this year.
The FDA is expected to reach a final decision by August 5, 2026, which would allow the vaccine to be available in time for the 2026-2027 flu season. Following the announcement, Moderna’s shares rose as much as 7.2%.
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Keywords: Moderna mRNA Flu Vaccine
Moderna mRNA Flu Vaccine
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