Why did the FDA initially refuse Moderna's flu vaccine application?

The FDA initially refused to file Moderna's flu vaccine application because the clinical trial data did not include another brand specifically recommended for people aged 65 and older.

What is Moderna's flu vaccine candidate and its status?

Moderna's flu vaccine candidate is named mRNA-100, and the FDA has reversed its decision to review the application for its approval.

When might Moderna's flu vaccine be available?

Pending FDA approval, Moderna aims to make its flu vaccine available to adults aged 50 and up for the 2026-27 flu season.

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FDA Reverses Decision on Moderna Flu Vaccine

18 Feb

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Summary

FDA will review Moderna's application for a seasonal flu vaccine.
The initial rejection was due to trial data not including a specific age group.
Moderna aims for availability to adults 50 and up for the 2026-27 season.

FDA Reverses Decision on Moderna Flu Vaccine

The U.S. Food and Drug Administration will now review Moderna's application for a seasonal flu vaccine, reversing a previous refusal. The initial rejection by the FDA's Center for Biologics Evaluation and Research centered on clinical trial data that excluded a specific age group. Moderna's candidate, mRNA-100, had demonstrated superior efficacy in adults aged 50 and older compared to existing standard flu shots.

Following a high-priority meeting, Moderna revised its application to seek approval for adults aged 50 to 64 and accelerated approval for those 65 and older. The company also committed to an additional study for older adults. The FDA is expected to make a decision by August, with Moderna targeting availability for the 2026-27 flu season. The vaccine candidate is also under review in Europe, Canada, and Australia.

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