Novavax, Inc. (Nasdaq: NVAX), an American biotechnology company developing next-generation vaccines for serious infectious diseases, announced the initiation of PREVENT-19, its pivotal Phase 3 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 company made an official statement on its website.
According to preliminary data, a trial to enroll up to 30,000 volunteers across approximately 115 sites in the U.S. and Mexico. Two-thirds of enrollees to receive an active vaccine. About 25 percent of the study population is intended to be in the 65 years of age or older group, about 15 percent are black/African American, nearly 10-20 percents are LatinX, and 1-2 percent of enrolled are Indian Americans.
Novavax President Stanley Erk said the test was an important step in creating a global portfolio of safe and effective vaccines to protect the world's population.
“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 full-length, prefusion spike protein made using Novavax’s 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.
As was noted by the company, the trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response and generated highly neutralizing antibodies against the virus.