FDA Grants Approval to Moderna's mRNA Flu Vaccine for Adults 50+
The U.S. Food and Drug Administration has approved Moderna's mRNA-based seasonal flu shot, mFLU-SIVA, for people aged 50 and older, marking the first flu vaccine using mRNA technology.
The Food and Drug Administration approved Moderna's mRNA-based seasonal influenza vaccine, mFLU-SIVA, for adults 50 years and older, the company announced on Wednesday. The approval makes it the first flu shot to use the same messenger RNA platform employed in COVID-19 vaccines and is expected to be available within weeks for the 2026-2027 flu season in the United States.
"The FDA approval of mFLU-SIVA demonstrates the continued strength and versatility of our mRNA platform," Moderna chief executive Stéphane Bancel said in a statement. "Flu remains a significant public health challenge, and mFLU-SIVA provides an important new option for America's seniors."
Clinical studies involving more than 40,000 participants indicated that the vaccine is safe and may offer stronger protection than conventional flu vaccines. An independent advisory panel that met in June voted unanimously to recommend approval.
Public health experts highlighted the potential advantages of mRNA technology, noting its faster development and easier updating when new flu strains emerge. Infectious disease specialist Michael Osterholm described the decision as "a critical step forward in advancing influenza vaccine technology," while Dr. Jeanne Marrazzo, chief executive of the Infectious Disease Society of America, said the approval signals openness to the platform and could improve responses to future flu seasons and other biological threats.