The test for the vaccine candidate, known as NVX-CoV2373, will evaluate the safety, efficacy and immune response in up to 30,000 people aged 18 years and older. This builds on phase 1/2 studies that have shown that the vaccine elicits an immune response and appears to be safe.
The trial examines whether the vaccine Covid-19 symptoms occur, as well as moderate or severe Covid-19 symptoms. All participants will be followed for 24 months after their second injection.
Two-thirds of participants will be assigned to receive two random injections of vaccine 21 days apart, and the remaining one-third will receive a placebo. The test sites are in places with ‘high transmission speeds’ to accelerate the accumulation of positive cases that can be effective’, reads the release.
According to Novavax, it is aimed at at least 25% of the study population being 65 years or older, at least 15% black, at least 10 to 20% Latinx and 1-2% American.
“With the COVID-19 pandemic raging worldwide, 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 CEO of Novavax, said in a news release.
The trial is being funded with Operation Warp Speed up to $ 1.6 billion.
Novavax is also currently conducting a Phase 3 clinical trial in the United Kingdom, a Phase 2b trial in South Africa and a Phase 1/2 continuation in the US and Australia, data as early as the first quarter of 2021 expected.
Two vaccines, from Pfizer / BioNTech and Moderna, have been approved for emergency use by the US Food and Drug Administration. Both began Phase 3 trials in the U.S. in July and more than 30,000 participants entered. Both are two doses of vaccines and have been shown to be 95% and 94.1% effective, respectively.
AstraZeneca launched the US Phase 3 trial of its coronavirus vaccine in September. Johnson & Johnson, which is testing a single-dose vaccine, expects efficacy results by January or February of its Phase 3 trial.