Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA (mRNA-1010), making it the first mRNA-based vaccine approved for seasonal influenza.
The vaccine is indicated for adults aged 50 years and older. FDA approval was based on positive data from a Phase 3 clinical trial that enrolled over 40,800 participants across 11 countries.
The regulatory milestone follows an initial setback earlier this year when the FDA issued a refusal-to-file action over Moderna’s choice of comparator vaccine in its Phase 3 trial a decision that prompted widespread industry debate across the biotechnology and pharmaceutical sectors. With this approval resolved, mFLUSIVA becomes Moderna’s 4th FDA-approved product and 5th approved product globally, signaling the expansion of its mRNA platform into a broader commercial vaccine portfolio.
Moderna plans to make mFLUSIVA available across the United States in time for the 2026–2027 influenza season.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
