Moderna announced on Aug. 6 that it has received approval from the Food and Drug Administration for its mRNA-based flu vaccine, mFLUVISA. The decision grants traditional approval for use in patients aged 50 through 64 years and accelerated approval for those 65 years and older.
According to Moderna, mFLUVISA is the first mRNA-based flu shot available in the United States. The company said it expects to make the vaccine available in the coming weeks, ahead of the 2026-2027 respiratory virus season. Pricing details were not disclosed.
Jefferies told investors that this approval adds another commercial growth driver for Moderna beyond its COVID-related revenues. Analysts expect sales of mFLUVISA to primarily occur in 2027 due to seasonal patterns of influenza infection.
The path to approval followed a refusal-to-file letter from the FDA earlier this year, signed by Vinay Prasad, former director of the Center for Biologics Evaluation and Research (CBER). Prasad said that Moderna’s pivotal study did not qualify as an "adequate and well-controlled trial," and questioned whether the control group reflected best-available care standards. Moderna disputed these claims, stating that FDA guidance does not require such controls and noting prior agency agreement with its Phase 3 plans.
After industry criticism, a revised application was accepted by the FDA. In June, an advisory committee voted unanimously in favor of approving mFLUVISA. The company reported results from a late-stage study showing that mFLUVISA was 26.6% more effective than a standard-dose commercial flu vaccine at preventing influenza among adults aged 50 years and older.
A post-marketing trial is underway to confirm clinical benefit in adults over age 65.
