July 31, 2020
HHS, DOD Partner With Sanofi and GSK on Commercial-Scale Manufacturing Demonstration Project to Produce Millions of COVID-19 Investigational Vaccine Doses
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today announced agreements with Sanofi and GlaxoSmithKline (GSK) to support advanced development including clinical trials and large-scale manufacturing of 100 million doses of a COVID-19 investigational adjuvanted vaccine.
By funding the manufacturing effort, the federal government will own the doses that result from the demonstration project. The adjuvanted vaccine doses could be used in clinical trials or, if the U.S. Food and Drug Administration (FDA) authorizes use, as outlined in agency guidance, the doses would be distributed as part of a COVID-19 vaccination campaign.
“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar. “Today’s investment supports our latest vaccine candidate, an adjuvanted product being developed by Sanofi and GSK, all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”
The manufacturing demonstration project will take place while clinical trials are underway. Working in parallel this way expedites the traditional vaccine development timeline. This step builds toward the U.S. government’s Operation Warp Speed goal to begin delivering millions of doses of safe and effective vaccines to the American people by the end of the year.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Army Contracting Command to provide approximately $2 billion to support late-stage development, clinical trials including a large-scale phase 3 efficacy clinical trial, and the manufacturing demonstration project. The U.S. government also has the ability to acquire up to 500 million additional doses.
The project also includes fill-finish manufacturing in the United States so that vaccine doses are packaged and ready to ship immediately if clinical trials are successful and FDA authorizes use. If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
Both companies have long-standing relationships with BARDA. Today’s effort with Sanofi builds on initial vaccine development work undertaken through a flexible agreement between BARDA and Protein Sciences, part of Sanofi, and work with GSK on adjuvant for pandemic influenza vaccines.
The vaccine candidate uses an antigen from Sanofi, which stimulates the body’s immune response against the virus, based on recombinant DNA technology and is being developed using an adjuvant from GSK to enhance the immune response, reduce the amount of antigen required per dose, and improve the chances of delivering an effective vaccine that can be manufactured at scale. GSK’s manufacturing scale is supported through U.S.-based reactivation efforts funded by BARDA since 2018.
About Operation Warp Speed (OWS):
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.