By Jennifer Doherty

Law360 (October 14, 2020, 8:21 PM EDT) -- The Trump administration announced a deal to fund two Phase 3 clinical trials of AstraZeneca's investigational COVID-19 antibody cocktail Wednesday at a total cost of $486 million as part of the government's Operation Warp Speed program.

The product, known as AZD7442, which has not received approval from the U.S. Food and Drug Administration, has the potential to help treat and prevent infection with SARS-CoV-2, the virus that causes the disease COVID-19, in certain high-risk groups including people receiving other medical treatments that would prevent them from using an eventual vaccine, according to a statement from the U.S. Department of Defense. If approved, the government said it would be distributed at no cost, though medical providers could still charge to administer it.

"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," Secretary of Health and Human Services Alex Azar said in the statement.

The deal follows President Donald Trump's public praise of another monoclonal antibody treatment, which uses laboratory-produced molecules to mimic the body's own immune system response to combat certain diseases, for helping him recover from COVID-19.

One of the government-funded Phase 3 trials will consist of monitoring 5,000 volunteers to see if the lab-created antibodies contained in the cocktail can safely and effectively prevent infection over 12 months. The second trial, consisting of 1,100 volunteers, will study whether the drug works as a post-exposure prophylaxis, meaning it prevents infection in people who have already been exposed to someone with COVID-19.

Along with the trials, the deal also includes funding for a project to demonstrate large-scale manufacturing of AZD7442 and for supplying doses to the U.S.

"The company estimates 100,000 doses of AZD7442 could be available from this project for the nation's high-risk population," the DOD said.

In its own statement, AstraZeneca said it planned to make those doses available by the end of 2020, giving the U.S. the possibility to purchase up to 1 million in 2021 through a separate agreement.

As of Oct. 14, no vaccine has been approved for the prevention of the disease, which has killed more than 210,000 people in the U.S. this year, according to Johns Hopkins University's Coronavirus Resource Center.

The government has invested more than $10 billion in the search for a vaccine since March, including $1.2 billion on AstraZeneca's vaccine candidate, AZD1222, according to information on HHS' Operation Warp Speed fact sheet.

Last month, the British pharmaceutical company paused global trials of AZD1222, citing safety concerns. It announced the resumption of its U.K. trial six days later; the U.S. trial was still on hold as of Wednesday evening.

Funds for the AstraZeneca deal came from HHS' Biomedical Advanced Research and Development Authority and the DOD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense as well as Army Contracting Command.

The announcement came a day after the government announced a $481 million deal with California-based medical diagnostics company Cue Health to increase its production capacity to 100,000 tests per day by March and to produce 6 million rapid COVID-19 tests for the government.

The test, which can detect the presence of genetic material from the virus in about 20 minutes, has received emergency use authorization from the FDA, allowing it to be used under the supervision of a qualified medical professional, the DOD said.

--Editing by Stephen Berg.

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