FDA Advisory Panel Scrutinizes Moderna's mRNA Flu Vaccine

• Moderna seeks traditional approval for ages 50-64 and accelerated approval for 65+, requiring additional studies for the older age group
• FDA reviewers flagged concerns about effectiveness in immunocompromised and very frail elderly patients excluded from trials, though the vaccine outperformed standard-dose shots in the 50-64 age group
• Analysts project $750 million in U.S. flu and COVID-flu combo vaccine sales by 2030, with revenue not expected until 2027; mRNA production avoids egg-based methods for faster strain matching

FDA Advisory Panel Reviews Moderna's mRNA Flu Vaccine

Key Development:

The FDA's Vaccine and Related Biological Products Advisory Committee is voting on Moderna's mFlusiva, which could become the first mRNA-based seasonal flu vaccine in the U.S. The company seeks traditional approval for adults aged 50-64 and accelerated approval for those 65 and older.

Background:

This review follows significant FDA leadership changes, including recent departures of Commissioner Marty Makary and vaccine chief Vinay Prasad amid controversies over vaccine reviews. Acting Commissioner Kyle Diamantas is working to stabilize operations and rebuild biotech sector relations. FDA initially rejected Moderna's application, citing concerns that the company failed to use the preferred higher-dose flu vaccine as a control for patients 65+ in clinical trials.

Clinical Data:

• Moderna's vaccine outperformed standard-dose shots in adults 50-64
• Generated strong immune response versus high-dose vaccines in 65+ age group
• FDA reviewers noted data demonstrating immune response might support approval for older adults
• Concerns remain about effectiveness in immunocompromised and very frail elderly patients excluded from trials

Technology Advantage:

Unlike traditional egg-based vaccines, mFlusiva uses mRNA technology, enabling faster production, better strain matching, and reduced time between strain selection and vaccine availability.

Market Implications:

• FDA decision expected by August 5
• Would compete with Sanofi, GSK, CSL Seqirus, and AstraZeneca
• Jefferies analyst projects no flu revenue until 2027, with $750 million in U.S. flu and COVID-flu combo vaccine sales by 2030
• Moderna has agreed to conduct additional studies if approved for 65+ age group