Novavax, Inc. has been selected to participate in Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a Phase III trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020. NVX‑CoV2373 consists of a stable, prefusion protein made using its nanoparticle technology and includes Novavax’ Matrix‑M adjuvant.
Novavax will work to rapidly scale up large-scale manufacturing and transition into ongoing production, including to stockpile and distribute large quantities of NVX-CoV2373 when needed. The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a Phase III trial with up to 30,000 subjects beginning in the fall of 2020.
This agreement also allows for a follow-on agreement with the U.S. government for additional production and procurement to support OWS’ vaccine production goal. This latest federal funding supports Novavax plans to file submissions with the U.S. FDA.