HHS provides $176 million for pandemic flu mRNA vaccine development

Strengthening pandemic preparedness with a flexible platform

The U.S. Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), part of the Agency for Strategic Preparedness and Response (ASPR), will provide approximately $176 million to Moderna for the development of an mRNA-based pandemic influenza vaccine.

The contract was awarded through BARDA's new Rapid Response Partnership Vehicle (RRPV) consortium, managed by Advanced Technology International (ATI). The RRPV is a 10-year, multi-purpose procurement vehicle and consortium partnership designed to support advanced research and development of medical countermeasures, including vaccines, therapeutics and diagnostics. The consortium will create flexible, strategic partnerships with industry that foster innovation and encourage collaboration.

“We have successfully applied lessons learned during the COVID-19 pandemic to prepare for future public health crises, including by addressing influenza and continuing to develop new vaccines and other tools to strengthen our pandemic response capacity,” Health and Human Services Secretary Xavier Becerra said. “Crucially, we are doing this work in partnership with some of the nation's leading scientists and clinicians. The Biden-Harris Administration will not stop until we have everything we need to be prepared for any pandemic or other public health emergency that affects the American people.”

This agreement will help Moderna further establish pandemic influenza vaccine response capabilities. These efforts will leverage its existing large-scale commercial mRNA-based manufacturing platform and ongoing seasonal influenza vaccine development in the United States. Additionally, ASPR has secured a fair pricing agreement, which will ensure equitable access to the vaccine in perpetuity. The U.S. Government is committed to leveraging its investments today to create cost equity for U.S. taxpayers in the future.

Moderna's influenza vaccine candidate uses the latest mRNA technology that was effectively utilized in the COVID-19 response, making it one of the first two COVID-19 vaccines to be FDA approved and ultimately FDA-authorized. In 2023, BARDA issued a request for proposals to Moderna and other companies to develop mRNA vaccines to prepare for a potential public health emergency (PHE) caused by influenza viruses such as avian influenza A (H5N1). mRNA vaccines could complement traditional vaccine technologies during a pandemic influenza emergency response. The U.S. Centers for Disease Control and Prevention (CDC) has stated that the risk to general human health from H5N1 is still low and that the grant is part of ASPR preparedness efforts.

“The awards made today are part of a long-standing commitment to strengthening pandemic influenza preparedness,” said Dawn O'Connell, Under Secretary for Preparedness and Response. “Adding this technology to our pandemic influenza preparedness toolkit will increase our ability to respond nimbly and rapidly to circulating strains and their potential variants.”

Moderna will prepare materials and conduct clinical trials to collect safety and immunogenicity data to support FDA authorization and potential commercial scale-up in response to future PHEs. The grant will enable the rapid development of an mRNA vaccine targeting different influenza virus subtypes (also called strains) with pandemic potential. The grant also includes options for large-scale production and pandemic response. Work under this grant will enable the company to rapidly pivot development and manufacturing, if needed, to address other threats, such as emerging infectious diseases.

If successfully developed, an mRNA-based licensed pandemic influenza vaccine could further shorten response timelines if a new viral strain emerges and causes a pandemic, such as H1N1 in 2009. Since 2005, BARDA has contracted with U.S. licensed influenza vaccine manufacturers to maintain and expand the national response capacity for influenza pandemics and other public health emergencies. Efforts under these contracts are intended to establish a fourth platform option to replace the egg-, cell-, and recombinant protein-based approaches used to manufacture existing licensed influenza vaccines.

This award is the newest component of the BARDA Influenza and Emerging Infectious Diseases Division’s medical preparedness portfolio.