FDA Approves Moderna Flu Vaccine for Adults 50+

On August 5, Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA, a new vaccine against seasonal influenza, for use by all adults 50 years and older.

This approval follows unanimous recommendations from the FDA's Vaccines and Related Biological Products Advisory Committee supporting mFLUSIVA for adults 50 years of age and older.

"The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," said Stéphane Bancel, CEO of Moderna. "Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors.

"This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation," she said. "We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible."

The FDA's approval of mFLUSIVA in adults 50 through 64 years of age is based on results from a randomized, observer-blind, active-controlled, Phase 3 clinical trial, which enrolled 40,805 adults aged 50 years and older across 11 countries.

Use in adults 65 years of age and older was granted accelerated approval based on results from a randomized, observer-blind, active-controlled clinical trial, which enrolled 2,992 adults 65 years of age and older in the United States.

Moderna expects to have mFLUSIVA available in the U.S. for the 2026-2027 respiratory virus season.

mRNA-1010 has been accepted for regulatory review in the European Union, Canada and Australia. Regulatory submissions in additional countries are planned during 2026.