The FDA is weighing Moderna’s mRNA flu vaccine ahead of an Aug. 5 decision.
Why it matters: An approval would put the first mRNA flu shot on the market and bolster Moderna’s pipeline. A setback would ripple across rival vaccine developers and the broader mRNA platform amid political scrutiny.
- The FDA’s target decision date for Moderna’s mRNA-1010, also called MFLUSIVA, is Aug. 5, 2026.
- An FDA advisory committee unanimously backed the shot on June 18 for adults 50 to 64 and 65 and older.
- Moderna says its BLA includes two Phase 3 studies with 43,808 participants and met all pre-specified primary endpoints.
- The agency initially refused to file the application in February, citing the Phase 3 comparator, before later agreeing to review it.
The FDA’s review of Moderna’s mRNA flu vaccine has become more than a routine approval decision. It is a test of whether the agency will back a first-of-its-kind shot built on a technology that has drawn both support and political attack.
Moderna’s candidate, mRNA-1010 or MFLUSIVA, could become the first mRNA flu vaccine to reach the market if the FDA approves it. The agency’s vaccine advisers met on June 18 and unanimously concluded that the benefits outweigh the risks for adults ages 50 to 64 and 65 and older, according to FDA meeting materials.
Moderna said in a filing with the SEC that its biologics license application includes two Phase 3 studies with 43,808 participants and that the vaccine met all pre-specified primary endpoints. The company also said FDA had previously indicated in April 2024 that a licensed standard-dose influenza vaccine comparator was acceptable for the study, after the agency’s Center for Biologics Evaluation and Research first issued a Refusal-to-File letter in February 2026 over the comparator used in the trial. Moderna’s SEC filing lays out that sequence.
STAT reported that the FDA later reversed course and agreed to review the vaccine, with a split pathway for adults 50 to 64 under standard review and adults over 65 under accelerated approval with a post-marketing study requirement. STAT reported the target decision date as Aug. 5, 2026.
The political backdrop is sharp. AP reported that Health Secretary Robert F. Kennedy Jr. has publicly criticized mRNA vaccines and announced the department was canceling $500 million in mRNA vaccine development funding. At the same time, advisers said the technology could help prepare for emerging strains in the future. AP reported on the funding cut.
Moderna said mRNA-1010 has also been accepted for review in the EU, Canada and Australia, with more submissions planned in 2026. The company has argued that this FDA decision could set the tone for how regulators treat novel vaccine platforms going forward.
By the numbers
- 43,808 - Participants in Moderna’s two Phase 3 studies
- 27% - Approximate reduction in flu cases versus comparator in one study, per AP
- Aug. 5, 2026 - Target FDA decision date
Yes, but: The FDA has not publicly issued a final approval or rejection in the materials provided, so the outcome remains pending.
What's next: The FDA’s target decision date is Aug. 5, 2026.