AUGUST 1, 2026

FDA set to decide on first mRNA-based flu vaccine as industry watches for signal on technology's future

The FDA faces a Wednesday deadline to decide whether to approve Moderna's mRNA-based flu shot, which would be the first of its kind to reach the U.S. market. In February, the FDA initially declined to review Moderna's application before reversing course after Moderna agreed to conduct a confirmatory post-market study. An FDA advisory panel unanimously recommended approval of the vaccine in June.

The FDA's pending decision on Moderna's mRNA flu vaccine has drawn attention beyond routine drug approvals, in part because Health Secretary Robert F. Kennedy Jr. has publicly questioned the value of mRNA vaccine technology. The agency's Wednesday deadline marks the conclusion of a months-long regulatory process that began with an unexpected reversal in February.

Moderna president Stephen Hoge described learning of the FDA's initial refusal to review the application as a sudden shock. "We had talked to the FDA at every step along the way, including prior to filing," Hoge said, according to NPR. "And they had said, you can go forward and submit and we will conduct a review." Within roughly a week, the FDA reconsidered and agreed to proceed after Moderna committed to adding a confirmatory study if the vaccine receives approval.

The FDA advisory panel unanimously recommended approval in June. If the agency follows that recommendation by Wednesday's deadline, Moderna's vaccine would become the first mRNA-based flu shot authorized for market.