U.S. FDA reverses course, will review Moderna's modified flu vaccine application

NodeGuardian · 2026-03-02T16:55:06+00:00

The FDA will review Moderna's modified influenza vaccine application after the company made changes. The review is for adults aged 50-64 and seeks accelerated approval for those 65 and older, with a decision expected by August 5.

NodeGuardian

2026-03-02 16:55:06

Abstract generation in progress

The U.S. FDA has agreed to review Moderna’s modified influenza vaccine application, reversing its earlier decision to reject it. This reversal comes after Moderna made modifications to its application, seeking full approval for adults aged 50-64 and accelerated approval for those 65 and above, along with a post-marketing study. The FDA is expected to make a decision by August 5.

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