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Law360 (July 7, 2020, 12:23 PM EDT) -- The U.S. government is pouring $1.6 billion into drugmaker Novavax Inc.'s efforts to develop a vaccine for COVID-19, the largest award yet under the Trump administration's campaign to fast-track treatments to fight the novel coronavirus, according to the company's Tuesday announcement.
The award was made under the Trump administration's Operation Warp Speed, a government initiative set on making 300 million doses of a COVID-19 vaccine available by January. In accepting the money, Novavax agreed to deliver 100 million doses of its vaccine candidate as early as late 2020, the company said.
The decision signals a high level of government confidence in a company that has yet to produce a market-ready drug. Novavax currently has nine drugs in development, none of which have been cleared by the U.S. Food and Drug Administration for commercial use, according to the company website.
A senior administration official told Law360 that Operation Warp Speed is taking advantage of all options to develop, manufacture and distribute a viable COVID-19 vaccine, and that Novavax's efforts, alongside other companies' proposed vaccines, are being monitored by the U.S. Department of Health and Human Services.
"Final approval for any promising vaccine candidate will come from an absolutely independent FDA that is solely focused on the scientific data and will not fall victim to political pressures," the official said in the statement.
"We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency," Novavax CEO Stanley C. Erck said in a statement. "We are grateful to the U.S. government for its confidence in our technology platform, and we are working tirelessly to develop a vaccine for this global health crisis."
The company said that its vaccine candidate, NVX-CoVd2373, is currently in late-stage clinical development. The federal funding will support the company's upcoming efforts to stage a Phase 3 clinical trial with up to 30,000 subjects, it said.
According to Novavax, the technology behind its proposed COVID-19 vaccine is the same technology used in the company's proposed flu and RSV F vaccines — drug candidates that have cleared Phase 3 testing and which are the furthest along in the company's development pipeline.
Representatives for Novavax weren't available for comment Tuesday.
The U.S. government has already awarded a total of $2 billion for five other vaccine candidates, including those being developed by AstraZeneca PLC, ModernTX Inc., Janssen Research & Development LLC, Merck & Co. Inc. and Protein Sciences Corp., which is a Sanofi subsidiary.
The AstraZeneca candidate is also in late-stage testing, according to the company's press release.
Novavax said that its candidate drug had previously secured a $388 million investment from the Coalition for Epidemic Preparedness Innovations, a vaccine development center founded by the Bill & Melinda Gates Foundation.
--Editing by Alyssa Miller.
Update: This story has been updated with more details about the award.
For a reprint of this article, please contact reprints@law360.com.
