Why did the FDA reject Moderna's mRNA flu vaccine?

The FDA rejected Moderna's mRNA flu vaccine application because it cited patient risks associated with the clinical trial design used by the company.

What was the dispute over Moderna's flu vaccine trial design?

The dispute centered on Moderna's choice of a comparison flu shot in its clinical trial, which the FDA deemed not to be the best standard of care, particularly for patients aged 65 and older.

What was Moderna's response to the FDA's rejection?

Moderna expressed surprise at the FDA's decision, stating that the agency had reviewed and cleared the trial design 18 months prior to the study's commencement.

Home / Health / FDA Defends Moderna Flu Shot Rejection

FDA Defends Moderna Flu Shot Rejection

12 Feb

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Summary

FDA rejected Moderna's mRNA flu vaccine application.
Agency cited patient risk due to trial design.
Moderna surprised by FDA's decision, questions guidance.

The Food and Drug Administration (FDA) on Wednesday defended its recent rejection of Moderna's mRNA-based flu vaccine application, asserting that the company's clinical trial design placed patients at risk. This unusual defense followed Moderna's statement that it was caught off guard by the regulatory decision.

The core of the disagreement lies in the comparison vaccine used by Moderna in its trial. The FDA contends that Moderna did not use the best standard of care, specifically for patients aged 65 and older, a group at higher risk for severe flu complications. Moderna used GSK's Fluarix Quadrivalent, which, while FDA-approved, is not the CDC-recommended high-dose flu shot for this demographic.

An unnamed senior FDA official suggested Moderna's choice of a "substandard" comparison vaccine was a deliberate attempt to make its own product appear more effective. This official denied incorrect guidance was given by the FDA and stated Health Secretary Robert F. Kennedy Jr. was not directly involved. The FDA indicated Moderna might resubmit its application for a narrower group if it acknowledges the agency's recommendations.