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Ana Santos Rutschman, Professor of Law, Villanova University

FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the law

In December 2025, Moderna submitted an application to the FDA to approve the first mRNA-based flu vaccine. Catherine Falls Commercial/Moment via Getty Images

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine.

The agency’s decision, which Moderna announced in a press release on Feb. 10, 2026, is the latest step in efforts by federal health officials under Health and Human Services Secretary Robert F. Kennedy Jr. to disrupt longstanding public health practices relating to vaccine access and approval, as well as to reshape the public’s perception of vaccine safety.

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