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Moderna Flu Vaccine FDA Review Reversal
18 Feb
Summary
- FDA has agreed to review Moderna's influenza vaccine application.
- Earlier, the FDA had rejected the application but Moderna made modifications.
- A decision on Moderna's flu vaccine is expected by August 5, 2026.
The U.S. Food and Drug Administration (FDA) has agreed to review Moderna's application for its influenza vaccine, a change from its earlier rejection. This decision came after Moderna implemented modifications to its submission.
The FDA will now review the revised approach for full approval for adults aged 50 to 64, and accelerated approval for individuals aged 65 and older. Moderna has committed to a post-marketing study for older adults.
This reconsideration follows the FDA's initial rejection, which was based on the company not administering a higher-strength vaccine to the control group of older patients. Moderna's CEO, Stéphane Bancel, expressed anticipation for making the flu vaccine available later in 2026.
The regulator is scheduled to make a final decision on Moderna's candidate by August 5, 2026. The vaccine utilizes mRNA technology, the same platform employed in many COVID-19 vaccines.
