Xavier Becerra, Secretary and Deputy Secretary & Andrea Palm, Deputy Secretary | https://www.hhs.gov/about/leadership/xavier-becerra.html https://www.hhs.gov/about/leadership/andrea-palm.html
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), has announced an allocation of approximately $176 million to Moderna for the development of an mRNA-based pandemic influenza vaccine.
This funding is provided via 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 aims to foster innovation and promote collaboration through strategic partnerships with industry.
“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.”
The award will enable Moderna to enhance its pandemic influenza vaccine response capability by leveraging existing U.S. domestic large-scale commercial mRNA-based manufacturing platforms alongside ongoing seasonal influenza vaccine development efforts. Additionally, ASPR has secured a fair pricing agreement aimed at ensuring equitable access to vaccines.
Moderna’s influenza vaccine candidate utilizes current mRNA technology that was successfully employed during the COVID-19 response. In 2023, BARDA issued a request for proposals from Moderna and other companies to develop mRNA vaccines in preparation for potential public health emergencies caused by influenza viruses such as avian influenza A(H5N1). According to the Centers for Disease Control and Prevention (CDC), while the risk from H5N1 remains low, this award is part of broader preparedness efforts by ASPR.
“The award made today is part of our longstanding commitment to strengthen our preparedness for pandemic influenza,” stated Assistant Secretary for Preparedness and Response Dawn O’Connell. “Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against circulating strains and their potential variants.”
Under this award, Moderna will prepare materials and conduct clinical trials aimed at collecting safety and immunogenicity data necessary for FDA licensure. This initiative also includes options for large-scale production should there be a need in response to future public health emergencies.
If successful, an mRNA-based licensed pandemic influenza vaccine could significantly improve response timelines in case a new virus strain emerges causing a pandemic similar to H1N1 in 2009. Since 2005, BARDA has been awarding contracts to manufacturers of licensed influenza vaccines in the U.S., aiming at sustaining national response capabilities during an influenza pandemic or other public health emergency.
This latest funding represents another component within BARDA's Influenza and Emerging Infectious Diseases Division's medical countermeasure portfolio.
