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Coronavirus In Maryland: Biotech Lab Novavax Selected To Receive $1.6B In Federal Funding For COVID-19 Vaccine Clinical Trial

GAITHERSBURG, Md. (WJZ) -- A Maryland biotechnology company will receive $1.6 billion in federal funding to help them to continue to develop and hold a clinical trial for a coronavirus vaccine this year.

Novavax received the funding through Operation Warp Speed, which is a federal program supporting the development of COVID-19 vaccinations and other countermeasures, to support late-stage clinical development -- including a Phase 3 clinical trial -- of NVX-CoV2373.

NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease.
NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

In a tweet, Gov. Larry Hogan thanked the company for their hard work.

"I want to congratulate @Novavax of Gaithersburg for receiving the largest Operation Warp Speed grant yet to accelerate development of a #COVID19 vaccine. Since day one, I've said that Maryland's biohealth institutions would lead the charge to develop treatments and vaccines," Hogan stated. 

The Gaithersburg-based company can also use the funding to help them with large-scale manufacturing of NVX‑CoV2373, including at least 100 million doses starting in late 2020.

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"The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government and funding entities join forces to defeat the novel coronavirus together. We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation's population," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis."

Under the agreement, Novavax will demonstrate it can rapidly manufacture the vaccine and move into ongoing production, which means creating a stockpile of the vaccine.

The clinical trial would include up to 30,000 subjects.

"Adding Novavax' candidate to Operation Warp Speed's diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year," said U.S. Health and Human Services Secretary Alex Azar. "Today's $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people."

This latest federal funding supports Novavax plans to file submissions for licensure with the U.S. Food and Drug Administration (FDA).

A Phase 1/2 clinical trial was administered to 130 health participants ages 18 to 59 in Austrailia in May. Preliminary results are expected in July.

 

 

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