By VETTAPHARMA reporter, February 19, 2026: Cambridge, Massachusetts — Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has initiated a formal review of its investigational seasonal influenza vaccine, mRNA-1010, marking a regulatory step forward after a previous setback.
According to the company’s news release, the FDA has accepted Moderna’s resubmitted Biologics License Application (BLA) for mRNA-1010 and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. If approved, the vaccine would be indicated for adults 50 years of age and older, including those aged 65 years and above, and could potentially be available for the 2026–2027 U.S. flu season.
The regulatory progress follows an earlier Refusal-to-File (RTF) letter issued by the FDA regarding the original submission, for more details Read Here. Moderna stated that after engaging with the agency, including a Type A meeting, it aligned on a revised regulatory pathway. Under the updated strategy, the company is seeking full approval for adults aged 50–64 years and accelerated approval for adults aged 65 years and older, with a post-marketing study commitment for the older population.
Moderna noted that mRNA-1010 has also been accepted for review in Europe, Canada, and Australia, with additional regulatory submissions planned in other markets during 2026.
The acceptance of the BLA for review represents a positive shift for the company’s influenza program and suggests that regulatory momentum is improving after earlier challenges. If approved, mRNA-1010 would expand Moderna’s respiratory vaccine portfolio and offer another seasonal influenza prevention option for older adults in the United States.
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This development follows earlier reporting highlighting regulatory challenges faced by Moderna’s flu vaccine program, including the FDA’s prior rejection of the initial submission. The latest acceptance for review indicates that things appear to be improving in the regulatory outlook for mRNA-1010.
Source credit:
- Moderna, Inc. (2026). Moderna announces the U.S. Food and Drug Administration will initiate the review of its investigational seasonal influenza vaccine submission. Click here
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