FDA refuses Moderna's application for new mRNA flu vaccine, company says

Feb 11, 2026 - 18:00
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FDA refuses Moderna's application for new mRNA flu vaccine, company says
 close up of a needle held in blue-gloved hands, extracting the solution into the syringe

Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how the company conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. Its a rare move by the FDA, which is under the control of Health Secretary Robert F. Kennedy Jr.

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