Moderna says FDA refuses to review its application for experimental flu shot

The FDA has declined to review Moderna's application for its experimental flu shot, mRNA-1010, causing the company's stock to drop about 7%. Moderna argues the decision contradicts earlier feedback from the agency and claims there were no specific safety or efficacy issues cited.

The FDA criticized the study design, stating it compared the vaccine to an inadequate standard, despite having previously approved the design.

Moderna believes the decision will not impact its 2026 financial outlook. The company seeks further discussions with the FDA, though it anticipates approval for the flu shot could come in late 2026 or 2027.

Moderna press release can be found here.