The U.S. Food and Drug Administration (FDA) has reversed its earlier stance and will now proceed with the regulatory review of Moderna’s mRNA-based influenza vaccine, known as mRNA-1010. This development follows a “Type A” meeting between the manufacturer and the agency. Just last week, the application had been dismissed due to concerns regarding the clinical trial’s control group.
The agency has established August 5 as the deadline for its decision. Moderna is currently seeking standard licensure for individuals aged 50 to 64 and accelerated authorization for those 65 and older. As part of the agreement, the company will conduct a post-market safety and efficacy study. If cleared, the vaccine is expected to be available for the 2026-2027 flu season.
Industry observers noted that the speed of this reversal is unusual, as such meetings typically take much longer to arrange. This shift comes at a time of heightened scrutiny regarding mRNA technology and changing federal health policies. Following the announcement, Moderna’s market valuation saw a positive impact, with shares rising by over 8% during Wednesday morning trading.