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FDA Defends Rare Refusal of Moderna Vaccine Application

Agency says trial used substandard comparator shot for seniors
Posted Feb 12, 2026 1:30 AM CST
FDA Says Moderna Skewed Trial for Its mRNA Flu Shot
FILE - A sign marks an entrance to a Moderna building in Cambridge, Mass., May 18, 2020.   (AP Photo/Bill Sikes, File)

Moderna's surprise stumble with its experimental mRNA flu shot is turning into a very public spat with its regulator, NBC News reports. One day after the company said it was blindsided by the Food and Drug Administration's refusal to review its vaccine application, the agency fired back, accusing Moderna of designing a trial that shortchanged older adults and could have put them at greater risk. At issue: Moderna tested its shot against GSK's Fluarix in people 65 and up, rather than the higher-dose vaccines the CDC prefers for that age group, Reuters reports. A senior FDA official, speaking anonymously, suggested the choice "rigged" the comparison to make Moderna's product look better, and rejected claims that Health Secretary Robert F. Kennedy Jr. influenced the call.

Moderna counters that FDA staff signed off on the trial plan 18 months ago and says shifting expectations without clear notice undermines industry trust. Outside experts are split; some say the FDA is right on the science but wrong to move the goalposts midstream. The anonymous FDA official says Moderna could narrow the age group for its application and "show some humility," but even if the company resubmits, one expert warns, it's unclear whether the FDA will give it a genuinely open-minded review.

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