By Blessing Nweke
Moderna said Wednesday that the U.S. Food and Drug Administration has agreed to review an amended application for its new flu vaccine, reversing course just a week after rejecting the company’s original submission and triggering concern among investors and industry observers.
Shares of Moderna rose about 6% following the announcement, recovering from an earlier decline of as much as 12% after news of the FDA’s initial refusal became public. The regulator is now expected to decide on the vaccine by August 5.
The reversal could pave the way for the first mRNA-based influenza vaccine in the United States and highlights ongoing volatility within the agency, which has experienced leadership changes under Health Secretary Robert F. Kennedy Jr..
In a rare public dispute, Moderna previously disclosed details of the FDA’s rejection letter, arguing that the agency had already approved the trial design when the study began 18 months earlier. FDA Commissioner Marty Makary defended the decision, saying officials were concerned that older participants in the trial’s control group did not receive a higher-strength vaccine.
Following a meeting between the company and regulators, the FDA accepted a revised application seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, contingent on a post-approval confirmatory study.
The policy shift comes amid broader changes to vaccine oversight during the administration of Donald Trump, with critics warning that evolving regulatory standards may affect vaccination rates and the development of new shots.
Analysts said the agency’s about-face could restore a potential revenue stream for Moderna that had been uncertain. Pending approval, the company expects to launch the flu shot in time for the 2026–2027 influenza season.
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