Spring 2025 - Safety

Grant Awarded to Accelerate Pandemic Influenza mRNA Vaccine Development

The U.S. Department of Health and Human Services (HHS) will provide approximately $590 million to Moderna to accelerate the development of mRNA based pandemic influenza vaccines and enhance mRNA platform capabilities so the U.S. is better prepared to respond to other emerging infectious diseases. This funding allows Moderna to accelerate development of an H5N1 mRNA influenza vaccine that is well matched to strains currently circulating in cows and birds and expands the clinical data supporting the use of mRNA vaccines that may be needed if other influenza strains emerge with pandemic potential.

Moderna’s influenza vaccine candidate uses conventional mRNA technology that was leveraged successfully during the COVID-19 response, resulting in one of the first two FDA-authorized — and ultimately FDA-licensed — COVID-19 vaccines.

In addition, Moderna will design and test an H7N9 mRNA pandemic influenza vaccine in a Phase III clinical study. If successful, this vaccine potentially could become the first licensed for H7N9. Moderna also will design up to four additional novel pandemic influenza vaccines and test preliminary safety and immunogenicity (generating an immune system response) in Phase I clinical studies. This work will create the necessary background data to enable accelerated development of an mRNA vaccine targeted to various influenza virus subtypes of pandemic potential. This approach takes advantage of the versatility of Moderna’s mRNA platform, leveraging an existing manufacturing platform capability to support product development across multiple health threats.

References

HHS Provides $590 Million to Accelerate Pandemic Influenza mRNAbased Vaccine Development, Enhance Platform Capability for Other Emerging Infectious Disease. U.S. Department of Health and Human Services press release, Jan. 17, 2025. Accessed at www.hhs.gov/about/ news/2025/01/17/hhs-provides-590-million-accelerate-pandemicinfluenza-mrna-based-vaccine-development-enhance-platform-capability-other-emerging-infectious-disease.html.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.