February 18, 2026
NPR recently published an article featuring Rena Conti, Associate Professor of Markets, Public Policy, and Law, discussing how the FDA has reversed its initial decision to reject Moderna’s application for a first-of-its-kind mRNA flu vaccine, agreeing instead to review the submission after the company amended its proposal.
The agency had previously declined to review the application, citing concerns that Moderna did not compare its vaccine to a high-dose flu shot for older adults in its primary clinical trials. Moderna disputed this, noting the FDA had earlier agreed to its study design and that additional comparative data had been included.
Following discussions, Moderna agreed to conduct a post-market confirmatory study in older adults using a high-dose flu vaccine comparator. With this adjustment, the FDA has now accepted the application for review.
“This type of chaotic decision-making is the opposite of what the regulator should be doing to regulate medicines in the U.S.,” Conti adds.
Moderna, which successfully deployed mRNA technology in its COVID-19 vaccine, has invested over $1 billion in developing the flu shot and aims to have it ready for the next flu season, pending regulatory approval.
