Moderna says FDA refuses its application for new mRNA flu vaccine

February 11, 2026

TL;DR

The FDA refused to file Moderna's application for a new mRNA flu vaccine.
Moderna believes the refusal is due to the FDA's heightened scrutiny of mRNA technology under Health Secretary Robert F. Kennedy Jr.
The FDA cited issues with the clinical trial's comparison to the standard of care as the reason for refusal.
Moderna stated the FDA did not identify safety or efficacy concerns and is seeking an urgent meeting.
Moderna has applied for approval of the vaccine in Europe, Canada, and Australia.
Health Secretary Robert F. Kennedy Jr. has previously criticized mRNA technology and reduced funding for its development in certain vaccines.
Senator Patty Murray condemned the FDA's decision, calling it unscientific and politically motivated.

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