The U.S. Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR), will provide approximately $176 million to Moderna for development of an mRNA-based pandemic influenza vaccine.
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The award was made through BARDA’s new Rapid Response Partnership Vehicle (RRPV) Consortium, managed by Advanced Technology International (ATI).
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 creates flexible, strategic partnerships with industry that foster innovation and promote collaboration.
“We have successfully taken lessons learned during the COVID-19 pandemic and used them to better prepare for future public health crises. As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities,” said HHS Secretary Xavier Becerra.
“Importantly, we are doing this work in partnership with some of the nation’s leading scientists and clinicians. The Biden-Harris Administration won’t stop until we have everything we need to prepare for pandemics and other public health emergencies that impact the American public.”
This award aids Moderna in ensuring the establishment of additional pandemic influenza vaccine response capability. These efforts will leverage existing U.S. domestic large-scale commercial mRNA-based manufacturing platforms and ongoing seasonal influenza vaccine development.
Additionally, ASPR has secured a fair pricing agreement which will continue ensuring enduring equitable access to vaccines. The U.S. government is committed to leveraging investments now to ensue cost parity for the American taxpayers in the future.
Moderna’s influenza vaccine candidate uses current mRNA technology leveraged successfully during the COVID-19 response, resulting in one of the first two FDA-authorized - and ultimately FDA-licensed - COVID-19 vaccines.
In 2023, BARDA issued a request for proposal to Moderna and other companies to develop mRNA vaccines to prepare for potential public health emergencies (PHEs) caused by influenza viruses, such as avian influenza A(H5N1).
mRNA vaccines have the potential to complement traditional vaccine technologies during a pandemic influenza emergency response. The Centers for Disease Control and Prevention (CDC) has said the risk to general human health from H5N1 is still low and this award is a part of ASPR preparedness efforts.
Moderna will prepare materials and conduct clinical trials to collect safety and immunogenicity data to support FDA licensure and potential commercial scale-up in response to a future PHE.
This award will enable the rapid development of an mRNA vaccine targeted to various influenza virus subtypes, also known as strains, of pandemic potential.
The award also includes the option for large-scale production and pandemic response. The work under this award will allow development and manufacturing to pivot quickly, if needed, to address other threats, such as emerging infectious diseases.
If successfully developed, an mRNA-based licensed pandemic influenza vaccine could further improve response timelines should a new virus strain emerge and cause a pandemic, as happened with H1N1 in 2009.
Since 2005, BARDA has awarded contracts to manufacturers of influenza vaccines licensed in the U.S. to sustain and expand national response capabilities in an influenza pandemic or other public health emergency.
Efforts under this award are intended to establish a fourth platform option to the egg-, cell-, and recombinant protein-based approaches used for production of existing, licensed influenza vaccines. ■
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