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Novavax Awarded $1.6B from Operation Warp Speed

Supports late-stage clinical development, large-scale manufacturing of NVX-CoV2373, including production of 100 million doses starting in late 2020.

By: Contract Pharma

Contract Pharma Staff

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 NVXCoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020. NVXCoV2373 consists of a stable, prefusion protein made using its nanoparticle technology and includes Novavax’ MatrixM 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.

 

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