Credit ACIP/CDC
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In the final days of the Biden-Harris administration we are seeing a flurry of pandemic preparedness steps ordered, including Thursday's HHS Intends to Provide $211 Million to Accelerate, Enhance Platform Capability for Emerging Infectious Diseases - new regulatory steps (see US FDA Issues New Requirements For Pet Food Manufacturers - APHIS Updates Turkey Surveillance Policies) - and the following HHS contract for pandemic vaccine development.
HHS Provides $590 Million to Accelerate Pandemic Influenza mRNA-based Vaccine Development, Enhance Platform Capability for Other Emerging Infectious Disease
Award bolsters pandemic preparedness by leveraging flexible platforms
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 that the U.S. is better prepared to respond to other emerging infectious diseases.
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).
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.
“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,” said HHS Secretary Xavier Becerra. “Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”
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.
“The award made today is part of the ASPR’s commitment to strengthening pandemic preparedness through investments in innovative technology such as mRNA vaccines,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “mRNA technology will complement existing vaccine technology, allowing us to move faster and better target emerging viruses to protect Americans’ against future pandemics.”
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).
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.
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.
This award is the latest component of the BARDA Influenza and Emerging Infectious Diseases Division’s medical countermeasure portfolio.
