By Hailey Konnath

Law360 (August 11, 2020, 10:58 PM EDT) -- Moderna Inc. landed a $1.5 billion supply agreement Tuesday with the U.S. Departments of Defense and Health and Human Services to manufacture 100 million doses of its COVID-19 vaccine candidate, a move the government billed as part of its efforts to make a vaccine available by the end of 2020.

The government has already poured hundreds of millions of dollars into developing the vaccine, called mRNA-1273, according to a statement from Moderna. The latest contribution comes from HHS' Biomedical Advanced Research and Development Authority and the DOD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, and the government has now committed a total of $2.48 billion to helping Moderna get the potential vaccine off the ground, Moderna said.

According to the White House, the federal government has invested more than $12 billion in six vaccine candidates. The government has also made similar deals with Sanofi, GlaxoSmithKline and, earlier this month, Johnson & Johnson.

Moderna will manufacture the mRNA-1273 doses while clinical trials are still underway, the DOD said in a statement Tuesday, expediting the traditional vaccine development timeline. Under the deal, the doses will be delivered to "government-designated locations" around the country, and the government can also acquire up to 400 million additional doses of the vaccine, the agency said.

If the vaccine is successful in clinical trials and garners the approval of the U.S. Food and Drug Administration, it would be free to Americans, the DOD said. However, the agency added that health care providers could still charge for administering the vaccine.

Moderna CEO Stéphane Bancel said in Tuesday's statement that the company is advancing the clinical development of mRNA-1273 with an ongoing study conducted in collaboration with the National Institute of Allergy and Infectious Diseases and BARDA.

"In parallel, we are scaling up our manufacturing capability ... to address this global health emergency with a safe and effective vaccine," Bancel said.

HHS Secretary Alex Azar said the investment in Moderna's vaccine candidate is the next step toward getting hundreds of millions of safe and effective doses to Americans. The government's vaccine portfolio "is increasing the likelihood that the United States will have at least one safe, effective vaccine by 2021," Azar said in the statement.

Moderna's said its vaccine was developed with scientists from the NIAID and the National Institutes of Health. The first clinical batch was completed in February, the company said, and the FDA granted mRNA-1273 fast-track designation in May. The third phase of clinical study is set to be complete next month, Moderna said.

However, Moderna revealed last week that it was uncertain about its patent rights for the vaccine. Specifically, the company said in U.S. Securities and Exchange filings that it "cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications."

The White House touted the Moderna deal, along with the government's other vaccine development agreements, at a press conference Tuesday. President Donald Trump said the agreement is part of the government's "Operation Warp Speed," which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.

"We've shaved years off of the time that it takes to develop a vaccine and we've done it while maintaining the FDA gold standard for safety," Trump said.

--Additional reporting by Jeannie O'Sullivan. Editing by Breda Lund.

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