Monday, July 15, 2024

Influenza Vaccine Development Receives $176 Million from HHS for Moderna’s mRNA-Based Research

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Influenza vaccine development will receive approximately $176 million in funding from 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). This funding is allocated to Moderna for creating an mRNA-based pandemic influenza vaccine.

This initiative is part of 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, including vaccines, therapeutics, and diagnostics. The consortium fosters innovation and promotes collaboration by creating flexible, strategic partnerships with industry.

HHS Secretary Xavier Becerra emphasized the importance of learning from the COVID-19 pandemic to better prepare for future public health crises. “We continue to develop new vaccines and other tools to address influenza and bolster our pandemic response capabilities,” said 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.”

Influenza Vaccine Funding Boosts Moderna’s mRNA Capabilities for Pandemic Preparedness

This funding will help Moderna establish additional pandemic influenza vaccine response capability, leveraging existing U.S. domestic large-scale commercial mRNA-based manufacturing platforms and ongoing seasonal influenza vaccine development. ASPR has also secured a fair pricing agreement to ensure enduring equitable access to vaccines, demonstrating the U.S. government’s commitment to leveraging current investments to ensure cost parity for American taxpayers in the future.

Moderna’s influenza vaccine candidate utilizes current mRNA technology, which was successfully leveraged 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). The Centers for Disease Control and Prevention (CDC) has stated that the risk to general human health from H5N1 is still low, and this award is part of ASPR’s preparedness efforts.

Assistant Secretary for Preparedness and Response Dawn O’Connell highlighted the significance of this award in enhancing pandemic influenza preparedness. “Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants,” said O’Connell.

Influenza Vaccine

Moderna Secures Funding for mRNA Influenza Vaccine Development and Rapid Pandemic Response

The funding will enable Moderna to 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 facilitate the rapid development of an mRNA vaccine targeted at various influenza virus subtypes of pandemic potential. The award also includes the option for large-scale production and pandemic response, allowing development and manufacturing to pivot quickly to address other threats, such as emerging infectious diseases.

If successfully developed, an mRNA-based licensed pandemic influenza vaccine could significantly improve response timelines should a new virus strain emerge and cause a pandemic, similar to the H1N1 outbreak 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. This award aims to establish a fourth platform option to the egg-, cell-, and recombinant protein-based approaches used for the production of existing, licensed influenza vaccines.

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This award is the latest component of the BARDA Influenza and Emerging Infectious Diseases Division’s medical countermeasure portfolio. The division continues to work on enhancing the preparedness and response capabilities of the U.S. by developing advanced technologies and forming strategic partnerships to address various public health threats. Through these efforts, BARDA aims to ensure the safety and health of the American public in the face of emerging infectious diseases and potential pandemics.

 

Resource: Health and Human Services, July 02, 2024

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