The pharma maker aims to make the treatment available to the most vulnerable populations by December.
The United States government and AstraZeneca are teaming up to develop and produce the pharma maker’s preventive COVID-19 treatment.
U.S. Department of Health and Human Services (HHS) and the Department of Defense is partnering with AstraZeneca for late-stage development and large-scale manufacturing of the pharma maker’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies that may help treat or prevent infection with SARS-CoV-2, HHS said in a press release.
“An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups,” HHS said. “This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine.”
Notably, If FDA authorizes use of AZD7442 for prevention of SARS-CoV-2, the federal government will distribute the doses at no cost. Howerver, “as is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product,” HHS said.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, and the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command will provide around $486 million to AstraZeneca for clinical trials and related development activities, including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the U.S.
AstraZeneca estimates 100,000 doses of AZD 7442 could be available for the high-risk population that may not benefit from a vaccine by December 2020.
"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.
One of the Phase 3 clinical trials of AZD7442 will evaluate safety and efficacy of the product to prevent infection for up to 12 months in approximately 5,000 volunteers. An additional Phase 3 clinical study will evaluate if AZD7442 can help prevent infection in people who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting.