The Biomedical Advanced Research and Development Authority (BARDA) will award up to $1.2 billion in funding to AstraZeneca to accelerate the development of a coronavirus vaccine called AZD1222, according to press releases from AstraZeneca and the U.S. Department of Health and Human Services.
The goal is to make at least 300 million doses of the vaccine available in the United States, beginning as early as October 2020.
AstraZeneca plans to begin Phase 3 clinical studies this summer with approximately 30,000 volunteers in the United States.
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 that supports large-scale production. A Phase 1/Phase 2 clinical study with 1,000 healthy volunteers aged 18 to 55 years has been underway in the United Kingdom since the end of April.
Financial support from BARDA, part of the HHS ’s office of the Assistant Secretary for Preparedness and Response, can be used for 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, according to HHS.
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.
AZD1222 is the fourth vaccine candidate to receive BARDA support for late-state development and manufacturing.
AstraZeneca said it has sourced total capacity for 1 billion doses through 2020 and into 2021; and is continuing to increase capacity further. In addition to the United States, AstraZeneca has been working with the United Kingdom and plans to supply 100 million vaccine doses to that country.
The company also said it is working with the Coalition for Epidemic Preparedness Innovations (CEPI); Gavi, the Vaccine Alliance; the World Health Organization (WHO) and other groups “in parallel to ensure broad and equitable supply of the vaccine throughout the world.”
