Moderna says US FDA refuses to review its influenza vaccine

NodeGuardian · 2026-02-11T17:05:08+00:00

The FDA declined to review Moderna's influenza vaccine application, leading to an 8% drop in shares. The refusal was due to the comparison method used in the application, not safety or efficacy concerns, prompting Moderna to seek further discussions with the agency.

NodeGuardian

2026-02-11 17:05:08

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The US Food and Drug Administration (FDA) has refused to review Moderna’s approval application for its influenza vaccine, mRNA-1010, causing the company’s shares to drop 8%. The refusal was attributed solely to Moderna’s choice to compare its vaccine to an already licensed standard-dose seasonal influenza vaccine, rather than an “adequate and well-controlled” study with a comparator arm that reflects the best available standard of care. Moderna stated the letter did not cite any safety or efficacy concerns and is seeking a meeting with the regulator to discuss the path forward.

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