Gianna is an associate editor of The American Journal of Managed Care® (AJMC®). She has been working on AJMC® since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey.
The Trump administration signed a $486 million agreement with AstraZeneca to develop a coronavirus disease 2019 (COVID-19) antibody treatment.
The Trump administration signed a $486 million agreement with AstraZeneca to develop a coronavirus disease 2019 (COVID-19) antibody treatment. Both HHS and the Department of Defense will partner with the company to roll out late-stage development and large-scale manufacturing of AZD7442, a cocktail of 2 monoclonal antibodies that holds potential as a treatment or a preventive of COVID-19, according to a HHS statement.
Specifically, the money will fund 2 phase 3 clinical trials and related development activities. One clinical trial will evaluate the cocktail’s safety and efficacy to prevent infection for up to 12 months in around 5000 volunteers, while the second trial will evaluate if AZD7442 can prevent infection in around 1100 volunteers who have come in contact with someone with COVID-19 in a post-exposure prophylaxis setting.
Part of Operation Warp Speed, the partnership aims to develop a cocktail that is of particular use in individuals with compromised immune function, those over the age of 80, or individuals undergoing medical treatment that precludes them from receiving a COVID-19 vaccine.
If the FDA grants Emergency Use Authorization of AZD7442, doses will be distributed by the federal government at no cost. However, “As is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product.”
AstraZeneca estimates 100,000 doses of the monoclonal antibody treatment could be available for the nation’s high-risk populations which may not benefit from a vaccine by December 2020.
Concurrent development and manufacturing “will accelerate the traditional product development timeline, should clinical trials prove successful and the FDA authorize use of the medicine,” the press release reads.
Discovered by Vanderbilt University, AZD7442 is a combination of 2 monoclonal antibodies modified using AstraZeneca’s proprietary half-life extension technology to extend their duration of action. The antibodies, synthesized in a laboratory, aim to mimic natural antibodies, and are administered via intramuscular injection.