11 February 2026 - Moderna said on Tuesday that the FDA has refused to review its application for an mRNA flu vaccine, with the company claiming this decision is inconsistent with previous communications from the agency.

In a press release Tuesday, Moderna said the FDA’s Center for Biologics Evaluation and Research (CBER) told the company it would not be initiating a review of its investigational mRNA vaccine. The company has requested a Type A meeting, a high-priority discussion with the FDA, to “understand” a path forward.

CBER Director Vinayak Prasad said the reason for the refusal was because Moderna chose a standard dose seasonal flu vaccine that has already been licensed as a comparison, according to the company. Moderna argued relevant regulations and guidance don’t reflect this reasoning.

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