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 traditional platforms, says GlobalData.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments, “The potential FDA approval of mRNA-1010 will be the first seasonal influenza mRNA vaccine and a great advancement for the market, as the utilization of mRNA technology in influenza vaccines will improve vaccine effectiveness.”

Influenza vaccines produced via mRNA technology will have a shorter production time than egg-based vaccines, cell-based vaccines, or recombinant vaccines, which are the seasonal influenza vaccines currently on the market. This decrease in production time means that the vaccines can be made closer to the start of flu season, thereby allowing for a better match to that season’s circulating influenza strains.

Likewise, Moderna has announced that pending the FDA’s approval of mRNA-1010, it will be available for a subset of patients in time for the 2026/2027 influenza season.

Kurdach continues, “In addition to advancing the seasonal influenza vaccines market, the potential FDA approval of mRNA-1010 will also stake Moderna’s claim in the market. As the uptake of the mRNA vaccine increases, the market share of the existing influenza vaccines will decrease, revealing Moderna’s role as a key player in the seasonal influenza vaccines space.” 

Following the FDA’s refusal-to-file (RTF) letter, Moderna proposed a revised regulatory pathway for mRNA-1010, including full approval for adults 50-64 years of age, accelerated approval for adults 65 and older, and a post-marketing study in older adults. The FDA accepted this revised application, after originally refusing to review Moderna’s application due to the choice in vaccine comparator in the Phase III study. Moderna reported Phase III data demonstrating statistical superiority of mRNA-1010 over the comparator vaccines.

Kurdach concludes, “One of the most prominent unmet needs for the prevention of seasonal influenza infections is enhanced vaccine effectiveness, and the utilisation of mRNA technology has the potential to fulfil this unmet need. According to GlobalData, the seasonal influenza vaccines development pipeline contains several mRNA vaccine candidates, including Pfizer’s PF-07252220 and GSK’s GSK4382276, both of which are in Phase II development.”