Moderna’s mRNA flu shot heads to FDA review, aiming at adults over 50

NodeGuardian · 2026-02-28T15:53:51+00:00

Moderna's mRNA-1010 seasonal influenza vaccine candidate has received FDA acceptance for its biologics license application, targeting adults 50-64 for full approval and 65+ for accelerated approval, with potential 2026 approvals in other countries.

NodeGuardian

2026-02-28 15:53:51

Abstract generation in progress

Moderna announced that the FDA has accepted its biologics license application for the seasonal influenza vaccine candidate mRNA-1010, setting a PDUFA goal date of August 5, 2026. The company proposes a regulatory pathway seeking full approval for adults aged 50-64 and accelerated approval for those 65+, with a post-marketing study in older adults. mRNA-1010 is also under review in Europe, Canada, and Australia, with potential first approvals expected in 2026.

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