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Moderna says FDA refuses its application for new mRNA flu vaccine

Associated Press (AP)EN 3 min read 100% complete by By  LAURAN NEERGAARD and MATTHEW PERRONEFebruary 11, 2026 at 12:53 AM
Moderna says FDA refuses its application for new mRNA flu vaccine
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medium article 3 min

The FDA has refused to consider Moderna's application for its new mRNA flu vaccine. The FDA issued a "refusal-to-file" letter objecting to Moderna's 40,000-person clinical trial, which compared the new vaccine to a standard flu shot and found it more effective in adults 50 and older. FDA vaccine director Dr. Vinay Prasad stated the trial was inadequate because it didn't compare the new shot to the best available standard of care in the US at the time of the study. The FDA pointed to advice given to Moderna in 2024 under the Biden administration, which Moderna didn't follow, regarding the use of a specific flu shot for seniors. Moderna claims the FDA initially agreed to the study's design.

Key Entities & Roles

Key Player Opposition Context
Biden administration 30% Washington 40% United States 50% Vinay Prasad 60% Robert F. Kennedy Jr. 70% Moderna ×790% Food and Drug Administration ×795%

Keywords

mrna flu vaccine 100% fda 90% refusal-to-file 80% clinical trial 70% moderna 70% vaccine approval 60% standard of care 50% mrna technology 50%

Sentiment Analysis

Negative
Score: -0.20

Source Transparency

Source
Associated Press (AP)
Classification Confidence
90%
Geographic Perspective
United States

This article was automatically classified using rule-based analysis.

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mrna flu vaccinefdarefusal-to-fileclinical trialmodernavaccine approvalstandard of caremrna technology
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