Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010. This announcement comes one week after the FDA’s Center for Biologics Evaluation and Research (CBER) notified Moderna that it would not initiate a review of mRNA-1010, and a Refusal-to-File (RTF) letter was issued, citing concerns over the choice of the vaccine comparator used in the Phase III trial. If approved, mRNA-1010 will be the first seasonal influenza mRNA vaccine on the market. This could transform the seasonal influenza vaccines market, as the utilisation 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. mRNA-1010 has also been accepted for regulatory review in the EU, Canada, and Australia.
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 uptake of the mRNA vaccine increases, due to its increased effectiveness, the market share of existing influenza vaccines will decrease, revealing Moderna’s role as a key player in the seasonal influenza vaccines space.
CBER’s RTF letter cited the choice of a licensed, standard-dose, seasonal influenza vaccine used as a vaccine comparator in the trial (rather than a vaccine specifically recommended for older adults, such as a high-dose or adjuvanted vaccine), as the reason for refusing to initiate a review of Moderna’s biologics licence application (BLA) for mRNA-1010. Previous written communication between Moderna and CBER discussed this point, and Moderna provided additional data from another Phase III trial comparing mRNA-1010 and a licensed, high-dose, seasonal influenza vaccine. All of the Phase III data that Moderna reported demonstrated statistical superiority of mRNA-1010 over the comparator vaccines. It appears that Moderna did not receive any indication that CBER would refuse to review the BLA.
Following CBER’s RTF letter, Moderna proposed a revised regulatory pathway for mRNA-1010, including full approval for adults aged 50–64 years, accelerated approval for adults 65 and older, and a post-marketing study in older adults. The FDA accepted this revised application and assigned a Prescription Drug User Fee Act (PDUFA) target date of 5 August 2026.
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 vaccine development pipeline contains several mRNA vaccine candidates, including Pfizer’s PF-07252220 and GSK’s GSK4382276, both of which are in Phase II development.
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