FDA to Review Moderna Flu Shot; PDUFA Goal Date August 5, 2026
FDA's Center for Biologics Evaluation and Research accepted Moderna's biologics license application for its mRNA-1010 seasonal influenza vaccine after a Type A meeting, setting a PDUFA goal date of August 5, 2026. Moderna's regulatory strategy targets full approval for ages 50–64 and accelerated approval for adults 65 and older.
1. FDA Acceptance and PDUFA Date
Moderna engaged with FDA's Center for Biologics Evaluation and Research in a Type A meeting after an initial refusal-to-file letter, leading to acceptance of its biologics license application for mRNA-1010 and establishment of an August 5, 2026 PDUFA goal date.
2. Regulatory Pathway Proposal
The company proposed full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, accompanied by a post-marketing requirement to conduct an additional study in the older cohort.
3. Vaccine Candidate and Potential Market Impact
mRNA-1010 is designed to leverage mRNA technology for broader seasonal influenza protection, and if approved it could enter the 2026-27 flu season market, potentially boosting Moderna's vaccine revenue.