In a race to find drugs and vaccine that can cure the coronavirus and treat patients with COVID-19, the U.S. government announced it is partnering with drugmaker AstraZeneca for at least 300 million doses of a coronavirus vaccine developed by the University of Oxford and committing up to $1.2 billion to the effort.
In response to response 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) said in a press release today that it’s collaborating with pharmaceutical giant AstraZeneca to make available at least 300 million doses of a coronavirus vaccine called AZD1222, with the first doses delivered as early as October 2020.
Under the public-private partnership, the Biomedical Advanced Research and Development Authority (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.
“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,” he said. The AZD1222 vaccine candidate was developed by Oxford in the United Kingdom and licensed to AstraZeneca, headquartered in Cambridge, England.
The deal between the drugmaker and the Biomedical Advanced Research and Development Authority (BARDA), a component of the Department of Health and Human Services, supports a Phase 3 clinical trial with 30,000 participants and a pediatric trial. AstraZeneca said it has concluded agreements for at least 400 million doses of the coronavirus vaccine and secured manufacturing capacity for 1 billion doses.
