FDA Moderna review sets up pivotal test for mRNA flu jabs

24 February 2026

US biotech Moderna (Nasdaq: MRNA) has won a fresh review from the US regulator for its seasonal influenza shot mRNA-1010, with a PDUFA decision due August 5, 2026, after an earlier refusal-to-file letter stalled the program.

The company has proposed full approval for adults aged 50 to 64 years and accelerated approval for those 65 and older, alongside a post-marketing study in seniors. The regulator has accepted the revised filing.

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