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FDA Reverses Decision, Will Review Moderna's mRNA Flu Vaccine After Amended Application

Feb 18, 2026

The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.

FDA Reverses Decision, Will Review Moderna's mRNA Flu Vaccine Application

Feb 16, 2026

The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.