Moderna says FDA will now review its new flu vaccine, reversing earlier decision

February 19, 2026

TL;DR

The FDA will review Moderna's application for its seasonal flu vaccine candidate, mRNA-100.
This decision reverses the FDA's earlier 'refusal to file' letter.
Moderna revised its application to seek approval for adults aged 50-64 and accelerated approval for those 65 and older.
The company also agreed to conduct an additional study for older adults.
A decision from the FDA is expected by August, with potential availability for the 2026-27 flu season.
The vaccine candidate is also under review in Europe, Canada, and Australia.

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