HHS announced an initial agreement with AstraZeneca in May 2020 to rapidly undertake development of an investigational vaccine in the United States with the mutual understanding that some of the specific terms and conditions would be determined as more became known about the vaccine candidate, manufacturing, and regulatory requirements.
Responding to President Trump’s call to develop 300 million doses of SARS-CoV-2 vaccine by January under Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and AstraZeneca are collaborating to make available at least 300 million doses of a coronavirus vaccine called AZD1222, with the first doses delivered as early as October 2020.
The agreement between AstraZeneca and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS office of the Assistant Secretary for Preparedness and Response, will accelerate the development and manufacturing of the company’s investigational vaccine to begin Phase 3 clinical studies this summer with approximately 30,000 volunteers in the United States.
Under this public-private partnership, BARDA can provide up to $1.2 billion to support, in parallel, advanced clinical studies, vaccine manufacturing technology transfer, process development, scaled-up manufacturing, and other development activities. Emergency use authorization or licensure of this vaccine from the U.S. Food and Drug Administration (FDA) would be required to make the vaccine available. Early milestones enable BARDA and AstraZeneca to determine how the program progresses forward.
“This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021,” said HHS Secretary Alex Azar. “Getting a vaccine to the American public as soon as possible is one part of President Trump’s multi-faceted strategy for safely reopening our country and bringing life back to normal, which is essential to Americans’ physical and mental well-being in so many ways. The Trump Administration is making multiple major investments in developing and manufacturing promising vaccines long before they’re approved so that a successful vaccine will reach the American people without a day wasted.”
The AZD1222 vaccine candidate, which was developed by the University of Oxford in the United Kingdom and licensed to AstraZeneca, uses a vaccine platform technology which supports large-scale production. To speed vaccine development, AstraZeneca will advance its vaccine candidate into late-stage clinical studies in parallel with scaled manufacturing at BARDA’s Centers for Innovation and Advanced Development in Manufacturing (CIADM) in the United States. Working with the CIADMs enables development, technology transfer, and scaled-up manufacturing of the vaccine in the United States.
A Phase 1/Phase 2 clinical study has been underway using the proposed technology in the United Kingdom since the end of April.
AZD1222 is the fourth vaccine candidate to receive BARDA support for late-state development and manufacturing. BARDA continues to collaborate through Operation Warp Speed with other federal agencies and private industry to develop and make available vaccines, treatments and diagnostic tests to combat COVID-19. To date, BARDA is supporting 31 medical products for the pandemic response; in addition to the four vaccine candidates, these products include seven treatments, 17 diagnostic tests, a test to screen donated blood for the virus, and two rapidly deployable technologies to aid health providers with early detection of sepsis in COVID-19 patients.
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, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. To learn more about the whole-of-America response to the coronavirus pandemic, visit www.coronavirus.gov and for more information about BARDA’s COVID-19 portfolio, visit www.medicalcountermeasures.gov.