The trial for the candidate vaccine, known as NVX-CoV2373, will assess the safety, efficacy and immune response in up to 30,000 people aged 18 and over. It is based on phase 1/2 studies that showed that the vaccine elicited an immune response and appeared to be safe.
The study is examining whether the vaccine prevents Covid-19 symptoms, as well as moderate or severe Covid-19 symptoms. All participants will be followed for 24 months after the second injection.
Two-thirds of the participants will be assigned to randomly receive two injections of vaccine administered 21 days apart, the remaining third will receive a placebo. The test sites are in locations that currently have high transmission rates “to accelerate the buildup of positive cases that can show effectiveness,” the statement said.
Novavax says it wants at least 25% of the study population to be 65 years or older, at least 15% to be black, at least 10 to 20% Latin and 1-2% American Indian.
“With the COVID-19 pandemic growing 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, a press release.
The test is being funded with up to $ 1.6 billion from Operation Warp Speed.
Novavax is also conducting a Phase 3 clinical study in the United Kingdom, a Phase 2b study in South Africa and a Phase 1/2 continuation in the USA and Australia, whose data is expected as early as the first quarter of 2021.
Two vaccines, from Pfizer / BioNTech and Moderna, have received emergency use authorization from the US Food and Drug Administration. Both started Phase 3 testing in the United States in July and registered more than 30,000 participants. Both are two-dose vaccines and have been shown to be 95% and 94.1% effective, respectively.
AstraZeneca started Phase 3 testing in the United States of its coronavirus vaccine in September. Johnson & Johnson, which is testing single-dose vaccines, is expecting results of effectiveness from its Phase 3 trial in January or February.