US FDA approves Moderna’s first mRNA flu vaccine

• A late-stage trial of over 40,000 adults showed mFlusiva was 26.6% more effective than standard-dose flu vaccines, and generated stronger antibody responses than Sanofi's high-dose vaccine in adults 65+
• Moderna missed the 2026 U.S. flu season contracting cycle, with analysts not expecting meaningful revenue until late 2027; Jefferies forecasts $750 million in U.S. sales by 2030 for the flu shot and planned COVID-flu combo vaccine
• The approval follows FDA leadership changes after the agency withdrew Moderna's combo shot application in 2025 amid heightened scrutiny, with the mRNA vaccine now competing against products from Sanofi, GSK, CSL Seqirus, and AstraZeneca

Summary

The U.S. FDA has approved Moderna's mFlusiva, the first mRNA-based seasonal flu vaccine, marking a significant milestone for the company and the technology. The vaccine received traditional approval for adults aged 50-64 and accelerated approval for those 65 and older, with Moderna required to submit additional confirmatory data for the older age group.

Key Data:

• Late-stage trial included over 40,000 adults aged 50+
• mFlusiva showed 26.6% greater effectiveness versus standard-dose flu vaccines
• Demonstrated stronger antibody responses than Sanofi's high-dose vaccine in adults 65+

Market Implications:

The vaccine will compete with existing flu shots from Sanofi, GSK, CSL Seqirus, and AstraZeneca. However, analysts don't expect meaningful revenue until H2 2027, as Moderna missed the 2026 U.S. flu season contracting cycle. Jefferies projects $750 million in combined U.S. sales for the flu vaccine and a COVID-flu combination shot by 2030.

This approval is crucial for Moderna as it seeks to replace declining COVID vaccine revenues and validate mRNA technology's commercial viability. The company's COVID-flu combination application was withdrawn last year after the FDA requested additional evidence, amid heightened regulatory scrutiny under previous leadership.

Technology Advantage:

The mRNA platform allows faster updates to match circulating flu strains compared to conventional egg-based vaccines, potentially offering a competitive edge.

The approval comes as the FDA, under Acting Commissioner Kyle Diamantas, works to rebuild industry confidence following controversies involving former officials and vaccine review processes.