“Novavax, Inc. … today announced 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 said in a news release.
Almost 30,000 volunteers in more than 100 cities in both countries will enroll the trial, and two-thirds of the participants will receive an active vaccine, it added.
Two initial phases of the trial demonstrated that the vaccine produces a robust immune response, generating a good amount of antibodies against the virus, the company noted.
“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”, Novavax president and chief executive officer Stanley Erck said.
Novavax is currently conducting different phases of scientific trials in such countries as the United Kingdom, South Africa, Australia.
The company said it plans to enroll people from different groups, including those intended to be in the 65 years of age or older, African Americans, Latin Americans and American Indians.
Novavax is the fifth company to launch a Phase 3 trial of a coronavirus vaccine in the US, following similar moves by Pfizer-BioNTech, Moderna, AstraZenca and Johnson & Johnson.
