The U.S. Food and Drug Administration approved Moderna’s flu vaccine for people aged 50 and older, the company announced on Wednesday, August 5, 2026. This marks the first approval of a messenger RNA vaccine for seasonal influenza.
The product, mFlusiva, received traditional approval for adults 50 to 64 and accelerated approval for those 65 and older. Moderna agreed to conduct an additional study and submit further data for the older group to confirm benefits.
The firm stated that flu remains a major public health issue and the vaccine offers an important new option for seniors.
Approval was based on a late-stage trial with more than 40,000 adults aged 50 and older showing the shot was 26.6 percent more effective than a standard-dose vaccine. Separate data showed stronger antibody responses than Sanofi’s high-dose version in adults 65 and older.
mFlusiva will compete with vaccines from Sanofi, GSK, CSL Seqirus and AstraZeneca. It uses mRNA technology to prompt production of influenza antigens and trigger immunity, potentially allowing faster strain updates. Conventional shots are mostly egg-based and contain viral proteins.
Analysts expect limited revenue until the second half of 2027, as the company missed the 2026 contracting cycle. Moderna hopes the vaccine and a future COVID-flu combination will offset lost COVID revenue and demonstrate mRNA potential amid some official resistance.
Jefferies analysts forecast 750 million dollars in U.S. sales by 2030. The combo application was withdrawn last year after the agency requested more evidence on the flu component. The withdrawal occurred during heightened FDA scrutiny under previous leadership, which led to resignations of former Commissioner Marty Makary and vaccine chief Vinay Prasad. Acting Commissioner Kyle Diamantas is now working to stabilize the agency and rebuild industry confidence.
