Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has been awarded $1.6 billion by the US government to participate in Operation Warp Speed (OWS), a US government program that aims to begin delivering millions of doses of a vaccine for COVID-19 in 2021. 

Under the agreement, Novavax will be responsible for: (1) completing late-stage clinical development, including a Phase III clinical trial, for its COVID-19 vaccine candidate, NVX CoV2373; (2) establishing large-scale manufacturing; and (3) delivering 100 million doses of its COVID-19 vaccine candidate as early as late 2020.

NVX‑CoV2373 consists of a stable, prefusion protein made using the company’s proprietary nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate neutralizing antibodies.

Under the agreement, Novavax will be required to demonstrate large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed. The agreement will fund the late-stage clinical studies of NVX-CoV2373, including a Phase III clinical trial with up to 30,000 subjects, beginning in the fall of 2020.

The agreement also allows for a follow-on agreement with the US government for additional production and procurement to support OWS’ vaccine production goal. This latest federal funding supports Novavax plans to file submissions for licensure with the US Food and Drug Administration.

A Phase I/II clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May (May 2020). Preliminary immunogenicity and safety results are expected at the end of July (July 2020), and the Phase II portion to assess immunity, safety, and COVID-19- disease reduction is expected to begin thereafter. The Phase I/II clinical trial is being supported by a funding arrangement worth up to $388 million from the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases.

Source: Novavax