Novavax, Inc. (NASDAQ: NVAX) announced the initiation of PREVENT-19, pivotal phase 3 study within the United States and Mexico to determinate the efficacy, immunogenicity and safety of NVX-CoV2373, the company’s COVID-19 vaccine candidate. “With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” said Stanley C. Erck, president and chief executive officer, Novavax. “We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the U.S. FDA and the government of Mexico on this program.”
NVX-CoV2373 contains a prefusion spike protein made by using the company’s recombinant nanoparticle technology and its proprietary saponin based Matrix-M adjuvant. PREVENT-19 is conducted with support from Operation Warp Speed partners which include the Department of Defense and the National Institute of Allergy and Infectious Diseases. The Biomedical Advanced Research and Development Authority is providing up to USD 1.6 Billion under a Department of Defense Agreement.
The company is currently conducting a large pivotal Phase 3 clinical study in the United Kingdom, a phase 2b safety and efficacy study in South Africa, including an ongoing phase 1 / 2 trial within the United States and Australia. Data from trials are expected as early as the first quarter of 2021 but may vary due to transmission rates in select regions.