Moderna Launches Late-Stage Bird Flu Vaccine Trial in US and UK

• The trial involves about 4,000 healthy adults aged 18 and older across the U.S. and UK, funded by $54 million from CEPI following the U.S. decision to cancel prior Moderna contracts for bird flu vaccine development
• Moderna has committed to reserving 20% of manufacturing capacity for low- and middle-income countries at affordable prices if the vaccine is approved and a flu pandemic is declared
• Regulatory approval will be supported by data from Moderna's separate seasonal flu vaccine candidate (mRNA-1010), currently under review in the U.S., EU, Canada, and Australia

Moderna Launches Late-Stage Bird Flu Vaccine Trial in US and UK

Key Development:

Moderna announced on April 21 it has initiated a late-stage clinical trial for its experimental bird flu vaccine (mRNA-1018) in the United States and United Kingdom. This marks the first time a pandemic bird flu vaccine using mRNA technology has reached late-stage trials.

Trial Details:

• Approximately 4,000 healthy adults aged 18 and older will participate
• The trial is supported by a $54 million investment from the Coalition for Epidemic Preparedness Innovations (CEPI)
• This follows U.S. Health Secretary Robert F. Kennedy Jr.'s decision last May to cut contracts with Moderna for bird flu vaccine development

Technology and Strategy:

The vaccine utilizes the same mRNA technology deployed in COVID-19 vaccines, offering a faster development method for emerging pandemic threats. CEO Stephane Bancel emphasized that bird flu remains a significant pandemic threat, positioning this trial as crucial for future outbreak preparedness.

Regulatory Pathway:

Any future regulatory approval application for mRNA-1018 will be supported by data from Moderna's separate seasonal flu vaccine candidate (mRNA-1010), currently under review in the U.S., EU, Canada, and Australia.

Global Access Commitment:

Under its CEPI agreement, Moderna has committed to reserving 20% of manufacturing capacity for low- and middle-income countries at affordable prices if the vaccine is approved and a flu pandemic is declared.

Market Implications:

This development positions Moderna at the forefront of pandemic preparedness efforts and demonstrates the expanding applications of mRNA vaccine technology beyond COVID-19, potentially strengthening the company's long-term vaccine portfolio.