News Related to mRNA-Based Influenza Vaccine

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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 Course, Agrees to Review Moderna's mRNA Flu Vaccine Application

Feb 17, 2026

The FDA agreed to review Moderna's mRNA-based flu vaccine after initially refusing, accepting a split regulatory approach with traditional approval for ages 50-64 and accelerated approval for 65 and older. Decision date set for August 5, 2026.