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The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.
The US Department of Health and Human Services (HHS) and Department of Defense (DoD) announced on Oct. 9, 2020 that they are entering into an agreement with AstraZeneca for $486 million for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational long-acting antibody combination product for treatment and prevention of COVID-19.
According to an HHS press release, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, in collaboration with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command will support two Phase III clinical trials of the investigational product, including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the US.
The first Phase III trial will involve 5000 participants and will determine the safety and efficacy of the product to prevent infection for up to 12 months, the press release said. The second study will involve 1100 volunteers. An additional Phase III study will be conducted if it is determined AZD7442 can help prevent infection in people who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting.
"In addition to Operation Warp Speed's historic progress on vaccines, we are supporting promising monoclonal antibodies for prevention and treatment all the way through to supply, allowing faster distribution if trials are successful," said HHS Secretary Alex Azar in the press release.