The U.S. Department of Health and Human Services (HHS) will provide approximately $590 million to Moderna to speed up the development of mRNA-based pandemic influenza vaccines and enhance mRNA platform capabilities so that the U.S. is better prepared to respond to emerging infectious diseases.
In 2023, BARDA began working with Moderna to help develop mRNA vaccine to prepare for potential public health emergencies (PHEs) caused by influenza viruses, such as avian influenza A(H5N1). Moderna initiated a Phase 1/2 study that same year to generate safety and immunogenicity data of an investigational pandemic influenza vaccine (mRNA-1018) in healthy adults aged 18 years and older. The study included vaccine candidates against H5 and H7 avian influenza viruses. Based on the positive preliminary data from the Phase 1/2 study, Moderna is preparing to advance mRNA-1018 into Phase 3.
Matching H5N1 Vaccine to Strains Currently Circulating in Dairy Cows, Cats
The new funding allows Moderna to accelerate development of a H5N1 mRNA influenza vaccine that is well matched to strains currently circulating and expands the clinical data supporting the use of mRNA vaccines that may be needed if other influenza strains emerge with pandemic potential.
“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past. That is why this response has been a top priority for the Biden-Harris Administration and HHS. Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”
HHS Secretary Xavier Becerra
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.
H7N9 Influenza Phase 3 Study
In addition, Moderna will design and test an H7N9 mRNA pandemic influenza vaccine in a phase 3 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 1 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.
Rapid Response Partnership Vehicle (RRPV) Consortium
The award was made through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR).
The RRPV is a 10-year, multi-purpose acquisition vehicle and consortium partnership designed to support advanced research and development of medical countermeasures, such as vaccines, therapeutics, and diagnostics. The consortium leverages BARDA’s authority to create flexible, strategic partnerships between government and industry that foster innovation and promote collaboration. BARDA also is providing funding to the RRPV for development of additional mRNA platform capacities.