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Thursday, May 11, 2023

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Fact Sheet: HHS Details $5 Billion ‘Project NextGen’ Initiative to Stay Ahead of COVID-19

Thanks to the Biden-Harris Administration’s whole-of-government approach to combatting COVID-19, we are now in a better place in our response than at any point of the pandemic. However, we need to continue to support the development of a new generation of tools to stay ahead of COVID-19.

An initial investment of $5 billion, collectively referred to as Project NextGen, will accelerate and streamline the rapid development of the next generation of vaccines and treatments through public-private collaborations.

Based at the U.S. Department of Health and Human Services (HHS) and led by the Administration for Strategic Preparedness and Response (ASPR’s) Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH’s) National Institute of Allergy and Infectious Diseases (NIAID), Project NextGen will coordinate across the federal government and the private sector to advance the pipeline of new, innovative vaccines and therapeutics into clinical trials and potential review by the U.S. Food and Drug Administration (FDA) for authorization or approval, and commercial availability for the American people.

The program will focus on several areas, including:

  • Mucosal vaccines such as those delivered intranasally, which could have the potential to dramatically reduce infection and transmission, in addition to preventing serious illness and death.
  • Vaccines that provide broader protection against variants of concern and a longer duration of protection.
  • Pan-Coronavirus vaccines which would protect against several different coronaviruses.
  • New, and more durable monoclonal antibodies that are resilient against new variants as they arise.
  • Advancing new technologies that will improve access and enable faster, cheaper, rapid, and more flexible production of vaccines and therapeutics.

Announced on April 10, the program has already started the activities necessary to bring next generation vaccines and treatments to Americans, including but not limited to:

  • Advanced development efforts at BARDA to examine immune responses across vaccines, including furthering our understanding of what correlates of immunity can predict the success of next-generation vaccines.
  • Leveraging NIAID clinical trial networks to evaluate multiple early candidate vaccines.
  • Public-private partnerships between BARDA and vaccine and therapeutic developers to de-risk product development.  
  • BARDA’s support of innovative manufacturing and platform approaches that will improve yields and will accelerate the availability of vaccines and therapeutics.

Building on experiences from HHS’s COVID-19 response efforts over the past 3-plus years, the Biden-Harris Administration will continue to address the ongoing threat of COVID-19 and to protect us against future epidemics from this same family of viruses.

To learn more, read BARDA’s latest Request for Information (RFI) and Areas of Interest under BARDA’s Broad Agency Announcement (BAAs) and easy broad agency announcement (EZ-BAA).