FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine mRNA-1010
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010, with a Prescription Drug User Fee Act (PDUFA) date set for August 5, 2026. 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.
The FDA's reversal followed a "Type A" meeting with agency officials in which the FDA agreed to set aside its earlier refusal to file letter and instead evaluate mRNA-1010. In return, Moderna proposed a revised regulatory pathway based on age, agreeing to seek full approval for adults ages 50–64 and accelerated approval for adults ages 65 and older, with the accelerated approval subject to a post-marketing requirement that Moderna conduct an additional study in older adults.
If approved, mRNA-1010 will be the first seasonal influenza mRNA vaccine on the market. 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.
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. The utilization of mRNA technology in influenza vaccines will improve vaccine effectiveness.
Moderna reported Phase III data demonstrating statistical superiority of mRNA-1010 over the comparator vaccines. Approval of the seasonal flu vaccine would also help Moderna by paving the way for approval of a combined COVID/flu vaccine, also being developed by Moderna, mRNA-1083.
Investors responded to the FDA's about-face with a buying surge that sent the company's stocks rising 6% from $43.93 to $46.60. The shares rose another 7% to $49.70, then finished the week inching up 0.3% Friday, closing at $49.87. Moderna shares have climbed 66% year to date and have more than doubled, soaring 123% since reaching their 52-week low of $22.28 on November 21, 2025.
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.