Novavax announces initiation of PREVENT-19 pivotal phase III efficacy trial of COVID-19 vaccine, NVX-CoV2373, in the United States and Mexico.

Novavax, Inc.announced initiation of PREVENT-19, its pivotal Phase III study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company’s COVID-19 vaccine candidate. The trial builds on research from Phase 1/II studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated. NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels. PREVENT-19 is being conducted with support from Operation Warp Speed partners, including the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response. BARDA is also providing up to $1.6 billion under a Department of Defense agreement (identifier MCDC OTA agreement number W15QKN-16-9-1002). The company is also currently conducting a large pivotal Phase III clinical study in the United Kingdom (U.K.), a Phase IIb safety and efficacy study in South Africa, and an ongoing Phase 1/II trial in the U.S. and Australia. Data from these trials are expected as soon as early first quarter 2021, although timing depends on transmission rates in the regions..