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

Jul 22, 2026

The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.

FDA Reverses Decision, Agrees to Review Moderna's mRNA Flu Vaccine

Feb 10, 2026

The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.