Late-stage biotech company Novavax Inc., which develops COVID-19 vaccine candidate NVX-CoV2373, will receive $1.6 billion funding under the U.S. government’s Operation Warp Speed program to speed up development of the vaccine. Continuing yesterday’s momentum, the stock is up 1.4 percent in premarket activity on Nasdaq.
The federal grant is to develop the drug, to establish large-scale manufacturing, and to deliver 100 million doses of NVX-CoV2373 as early as late 2020.
The latest federal funding supports Novavax’ plans to file submissions for licensure with the U.S. Food and Drug Administration.
Maryland Gov. Larry Hogan tweeted that Novavax of Gaithersburg received the largest Operation Warp Speed grant yet to accelerate development of a COVID19 vaccine.
The Maryland-based vaccine maker, which is yet to launch its first product to the market, said in a statement that the grant would allow it to complete late-stage clinical development, including a pivotal Phase 3 clinical trial, necessary to determine the safety and efficacy of NVX-CoV2373. The Phase 3 clinical trial with up to 30,000 subjects will begin in the fall of 2020.
Under the deal, the company will also be allowed for a follow-on agreement with the U.S. government for additional production and procurement to support OWS’ vaccine production goal.
Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 is currently under a phase I/II trial, with preliminary immunogenicity and safety results from the phase I portion of the trial expected in July 2020. The company would begin the Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction thereafter.
The company has already received $388 million in funding from the Coalition for Epidemic Preparedness Innovations to support the phase I/II trial.
Novavax in early June received up to $60 million in funding from the U.S. Department of Defense or DoD to advance clinical development of the vaccine candidate. The agreement includes a 2020 delivery of 10 million doses of the vaccine candidate that could be used in Phase 2/3 clinical trials or under an Emergency Use Authorization if approved by the U.S. FDA.
The Operation Warp Speed or OWS program aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. Under the program, drug makers Moderna, Astrazeneca, Johnson & Johnson, Merck & Co., and Pfizer have received federal grant for the development of their respective Covid-19 vaccine.
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