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Tuesday, July 7, 2020

-=Novavax (NVAX) selected to participate in Operation Warp Speed

Novavax has been selected to participate in Operation Warp Speed, 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 pivotal Phase 3 clinical 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 proprietary nanoparticle technology and includes Novavax' proprietary Matrix-Madjuvant. Under the terms of the agreement, Novavax will demonstrate it can rapidly stand up 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 necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.
  • Today's 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 for licensure with the U.S. Food and Drug Administration (FDA).

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