The U.S. Department of Health and Human Services announced Tuesday that it would invest $1.6 billion toward the commercial development of a COVID-19 investigational vaccine by the Maryland-based company Novavax.

HHS also announced that it would provide $450 million to Regeneron to manufacture and supply the company’s antiviral antibody treatment, REGN-COV2.

The clinical trials for both the vaccine and the treatment are still underway.

The funding projects were undertaken as a joint effort between HHS and the Department of Defense as part of Operation Warp Speed, the Trump administration’s initiative to deliver 300 million doses of COVID-19 vaccine by January 2021. 

“Depending on success in clinical trials, today’s $1.6 billion investment supports our latest vaccine candidate, being developed by Novavax, all the way through clinical trials and manufacturing 100 million doses for the American people,” said HHS Secretary Alex Azar.

The $1.6 billion, according to Novavax, will be put toward clinical development and trials, the establishment of large-scale manufacturing, and the delivery of 100 million vaccine doses. As reported by the New York Times, Novavax has not yet brought a product to market. 

The government will own any doses of the vaccine and treatment resulting from the projects, HHS said. 

“If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost,” said the agency in a press release. “As is customary with government-purchased vaccines, healthcare professionals could charge insurers for the cost of administering the vaccine.”

Regeneron said in a press statement that, should the U.S. Food and Drug Administration grant emergency use authorization or product approval for the treatment, “the government has committed to making doses from these lots available to the American people at no cost and would be responsible for their distribution.”

“This agreement with Regeneron is the first of a number of Operation Warp Speed awards to support potential therapeutics all the way through to manufacturing, allowing faster distribution if trials are successful,” said Azar.

HHS announced on May 15 that 14 vaccine candidates had been chosen under Operation Warp Speed with the intention of being narrowed down to about seven. The agency had already allocated hundreds of millions in funds to support the development of Johnson & Johnson, Moderna and AstraZeneca’s candidate vaccines.

The HHS announcement comes on the heels of the FDA’s decision to grant emergency use authorization to a point-of-care 15-minute COVID-19 antigen test produced by Becton Dickinson. 

On Tuesday, however, the FDA also issued a warning about false positive rates from a different Becton Dickinson COVID-19 test, which had been granted an emergency use authorization in April.

Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Healthcare IT News is a HIMSS Media publication.

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