WASHINGTON — The U.S. Food and Drug Administration on Wednesday approved the nation's first messenger RNA-based flu vaccine, clearing Moderna's mFlusiva for adults 50 and older.
The approval, which came Aug. 5, 2026, introduces a flu shot that uses mRNA technology to allow faster adaptation to circulating virus strains — an advantage over conventional vaccine manufacturing.
The regulatory pathway drew initial pushback, according to news reports, a pattern common for novel vaccine platforms. The FDA did not detail specific aspects of its review process.
Adults 50 and older face higher risk of severe flu complications, hospitalizations and death, making them a priority target for updated vaccine options.
The clearance opens Moderna to the established seasonal flu market, where it will compete with traditional manufacturers. The company built its mRNA platform through its COVID-19 vaccine program.
Other pharmaceutical companies investing in mRNA research will be watching the pathway Moderna and the FDA established for similar vaccines targeting other pathogens.
Questions remain about public uptake and whether mFlusiva will lift overall flu vaccination rates among older Americans.
