Novavax is one of the U.S. biotech companies working on a vaccine against COVID-19. Its vaccine candidate, NVX-CoV2373, began Phase I testing in Australia in April. Last week, only two weeks after receiving $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI), the Maryland-based company enrolled and dosed the first patients in a Phase I/II study and hopes for preliminary immunogenicity and safety data in July.
Now Novavax has received $60 million in funding from the U.S. Department of Defense (DoD) to manufacture the vaccine candidate. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CRBND-EB), with funding from the Defense Health Program, is supporting Novavax’s manufacture of several components of the vaccine in the U.S. The deal includes a plan to deliver 10 million doses of NVX-C0V2373 to the DoD in 2020 that can be used in a Phase II/III clinical trial or under an Emergency Use Authorization (EUA) if the U.S. Food and Drug Administration (FDA) grants it.
“We are genuinely honored at the opportunity to protect our military personnel and their families who have devoted themselves to the needs of U.S. citizens and others worldwide,” said Stanley C. Erck, president and chief executive officer of Novavax. “Importantly, this award will allow Novavax to significantly expand its U.S. production capacity of NVX-CoV2373, a critical step in our ability to provide vaccine support to the COVID-19 pandemic.”
Novavax’s vaccine leverages its Matrix-M adjuvant, which improves the immunogenicity, allowing for lower doses of the vaccine. The vaccine candidate is made up of a stable, prefusion protein antigen. It was developed using the company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein.
According to the World Health Organization (WHO) there are more than 133 COVID-19 vaccines in development around the world. Many of the companies, particularly with the most promising vaccines, are beginning wide-scale manufacturing ahead of approval in hopes that, once approved, distribution can begin immediately.
On June 2, the U.S. government’s Operation Warp Speed signed a $628 million contract with contract development and manufacturing organization (CDMO) Emergent BioSolutions to accelerate domestic production of leading COVID-19 vaccine candidates through 2021.
Many of the smaller biotech companies working on COVID-19 vaccines have partnered with larger biopharma companies to handle distribution and manufacturing. These include Pfizer and BioNTech, Moderna and Switzerland’s Lonza, as well as individual efforts by GlaxoSmithKline, Johnson & Johnson, and Sanofi. There is a recognition that with a need to vaccinate most of the world, no one company or product is likely to be sufficient.
Jun 05, 2020