The candidate vaccine trial named NVX-CoV2373 will evaluate the safety, efficacy and immune response of up to 30,000 people 18 years and older. It is based on a Phase 1/2 study, which showed that the vaccine caused an immune response and appeared to be safe.
The trial is investigating whether the vaccine can prevent Covid-19 symptoms and moderate or severe Covid-19 symptoms. After the second injection, all participants will be followed up for 24 months.
Two-thirds of the participants will be randomly assigned two injections of the vaccine, 21 days apart, and the remaining third will receive a placebo. The press release stated that these test sites are located in locations that currently have high transmission rates to “accelerate the accumulation of positive cases that may show efficacy.”
Novavax said its goal is to have at least 25% of the study population aged 65 years or older, at least 15% black, at least 10% to 20% Latino and 1-2% American Indian.
Stanley C. Erck, President and CEO of Novavax, said in an interview: “As the COV-19-19 pandemic rages on a global scale, this trial is to establish a safe and effective global vaccine portfolio. A key step to protect the world’s population.” Press release.
The experiment received up to $1.6 billion in funding from Operation Warp Speed.
Novavax is currently conducting Phase 3 clinical trials in the UK, Phase 2b clinical trials in South Africa, and Phase 1/2 clinical trials in the United States and Australia. The data is expected to be released in the first quarter of 2021.
Both Pfizer/BioNTech and Moderna vaccines have received emergency use authorization from the U.S. Food and Drug Administration. Both companies started Phase 3 trials in the United States in July and recruited more than 30,000 participants. Both are vaccines in two doses and have been shown to have 95% and 94.1% efficacy, respectively.
AstraZeneca began a phase 3 trial of its coronavirus vaccine in the United States in September. Johnson & Johnson is testing a single-dose vaccine, and it is expected that its Phase I or Phase III trial in February will produce efficacy.