Novavax announced Tuesday that it has been awarded $1.6 billion by the US government to progress development of NVX CoV2373 and potentially deliver 100 million doses of the COVID-19 vaccine as early as late 2020. Shares in the company jumped as much as 44% on the news.
NVX‑CoV2373 consists of a stable, prefusion protein made using Novavax's nanoparticle technology and includes the company's Matrix‑M adjuvant. A Phase I/II study of the vaccine began in May, with preliminary immunogenicity and safety results expected at the end of this month, after which the Phase II portion to assess immunity and COVID-19 disease reduction will start. The trial is being supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), including an investment of up to $384 million made in May.
Pivotal study, manufacturing
The latest funding, which comes via the Operation Warp Speed initiative, will be used to conduct late-stage studies of NVX-CoV2373, including a pivotal Phase III trial with up to 30,000 subjects beginning as early as October. Novavax noted that the funding will also be used to demonstrate that it can rapidly establish large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed.
"What this Warp Speed award does is it pays for production of 100 million doses, which would be delivered starting in the fourth quarter of this year, and may be completed by January or February of next year," Novavax CEO Stanley Erck said. The executive added that by early next year the company expects to be able to make 50 million doses a month in the US.
Novavax previously suggested that the CEPI funding would potentially enable it to manufacture up to 100 million doses by the end of 2020, with a goal of potentially producing over 1 billion doses during 2021. Novavax said Tuesday that the latest deal also allows for a follow-on agreement with the US government for additional production and procurement to support Operation Warp Speed's vaccine production goal. "It's a big scale up in a few different manufacturing sites in the US," Erck said, adding "what it leaves us with is the capacity of making many more doses in the US in 2021."
"Adding Novavax's 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," remarked US Health and Human Services Secretary Alex Azar. Other vaccine candidates that are part of the programme include those being developed by AstraZeneca, Johnson & Johnson, Merck & Co., Moderna and Pfizer, and more recently Vaxart.
Global production sites
Meanwhile, Erck noted that Novavax also has a manufacturing plant in the Czech Republic and hopes to have two other plants in Europe, as well as one in Asia. In addition, the company is working with a manufacturer in India, with the aim there being to make more than 100 million doses a month, Erck said.
Separately on Tuesday, Regeneron Pharmaceuticals received a contract worth $450 million as part of Operation Warp Speed to manufacture and supply its investigational double antibody cocktail REGN-COV2 for the treatment and prevention of COVID-19.
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