FDA Commissioner Says Agency Not Against mRNA Vaccines

FDA Commissioner Says Agency Not Against mRNA Vaccines

The Food and Drug Administration commissioner said on Feb. 23 that the agency is not opposed to vaccines using messenger ribonucleic acid (mRNA) technology, shortly after the agency agreed to consider an mRNA influenza vaccine from Moderna following an initial rejection of the company’s application. “I think that would be quite a stretch, to say we’re not embracing mRNA vaccines. We’ve approved two mRNA vaccines at the beginning of my time,” Dr.…

FDA reverses decision and agrees to review Moderna’s flu vaccine – PR informa

A flu vaccine is prepared in Mountain Lakes, N.J., Sept. 16, 2025. (Laila Stevens/The New York Times) By CHRISTINA JEWETT and REBECCA ROBBINS The Food and Drug Administration reversed its decision on Moderna’s flu vaccine and has agreed to review it for possible approval. On Feb. 10, Moderna announced that the agency had rejected its application for review of a new flu vaccine. The FDA said the company’s research design had been flawed. But in s…

FDA reversal on Moderna’s mRNA-1010 can transform the seasonal influenza vaccines market: GlobalData

The US Food and Drug Administration’s (FDA) decision to review Moderna’s mRNA-1010, with a Prescription Drug User Fee Act (PDUFA) date set for 05 August 2026, signals a pivotal inflection point for the seasonal influenza vaccines market. If approved, the candidate will introduce the first mRNA-based flu vaccine, potentially redefining production timelines, strain matching precision, and competitive dynamics across a market long dominated by trad…