By Craig Clough

Law360 (October 29, 2020, 11:27 PM EDT) -- The U.S. Department of Defense said Thursday that AstraZeneca Pharmaceuticals LP has been awarded a contract for nearly $287 million to deliver around 200 million doses of AZD1222, which is being developed as a potential vaccine for COVID-19.

The contract with the U.S. Army has an estimated completion date of June 30, 2021, with work on the vaccine to be performed in West Chester Township, Ohio, and Albuquerque, New Mexico, the DOD said.

The government announced in May it was investing at least $1.2 billion in AZD1222, according to information on the fact sheet for the U.S. Department of Health and Human Services' Operation Warp Speed — the official name of the administration's COVID-19 vaccine development initiative. The DOD's announcement Thursday did not clarify what relation the new contract has with the previously announced $1.2 billion investment.

The arrangement announced in May was a "major milestone" in the Trump administration's push to make 300 million doses of a COVID-19 vaccine available by January, HHS Secretary Alex Azar said at the time.

Phase III testing of AZD1222 began in August with approximately 30,000 adult volunteers at 80 sites in the United States, according to HHS. The company, which is developing the vaccine with Oxford University, paused clinical trials in September after a patient became sick, but the trials resumed as of Oct. 23, with the U.S. Food and Drug Administration approving the resumption, the company said.

"The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic," AstraZeneca CEO Pascal Soriot said in a statement Oct. 23. "We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use."

No vaccine has been approved by the FDA for the prevention of COVID-19, which has killed more than 228,000 people in the U.S. this year, according to Johns Hopkins University's Coronavirus Resource Center.

On Oct. 14, the Trump administration announced a deal to fund two Phase 3 clinical trials of AstraZeneca's experimental COVID-19 antibody cocktail AZD7442, at a total cost of $486 million as part of the Operation Warp Speed program.

The antibody treatment, which has not received FDA approval, has the potential to help treat and prevent COVID-19 infection in certain high-risk groups, including people receiving other medical treatments that would prevent them from getting an eventual vaccine, according to a statement from the DOD. If approved, the government said it would be distributed at no cost, though medical providers could still charge to administer it.

The DOD's announcement Thursday on AstraZeneca's vaccine comes not long after two Democratic U.S. senators urged the Senate Armed Services Committee to hold a hearing on the Pentagon's "outsized" role in a program to develop a COVID-19 vaccine, including more than $6 billion in related contracts they said may violate acquisition regulations.

The Armed Services Committee has yet to schedule a hearing dedicated to the DOD's efforts to respond to the pandemic, and recent reports indicate that the agency's role in the Operation Warp Speed vaccine program is much more prominent than it had previously announced, Sens. Elizabeth Warren, D-Mass., and Mazie Hirono, D-Hawaii, said in an Oct. 23 letter to the committee's leaders.

"Given the outsized role DOD appears to be playing in vaccine development and distribution, we request the SASC immediately hold a hearing on this matter," said the senators, both members of the committee.

--Additional reporting by Daniel Wilson and Jennifer Doherty. Editing by Breda Lund.

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