Phase 3 clinical trials of the Novavax Covid-19 vaccine are set to start in the United States and Mexico, the company announced on Monday.
The trial for the vaccine candidate, known as NVX-CoV2373, will evaluate safety, efficacy and immune response in up to 30,000 people age 18 and older. It builds on Phase 1 and 2 studies that demonstrated the vaccine provoked an immune response and appeared to be safe.
The trial is examining whether the vaccine prevents moderate Covid-19 symptoms, as well as severe Covid-19 symptoms.
Two-thirds of participants will be assigned to randomly receive two injections of vaccine administered 21 days apart, the remaining one-third will receive a placebo. The trials sites are in locations that currently have high transmission rates "to accelerate the accumulation of positive cases that could show efficacy," a statement said.
Novavax says it aims for at least 25% of the study population to be age 65 or older, at least 15% to be Black, at least 10 to 20% Latinx and 1-2% American Indian.
The trial is being funded with up to $1.6 billion from Operation Warp Speed.
Some background: Novavax is also currently conducting a Phase 3 clinical study in the United Kingdom, a Phase 2b trial in South Africa and a Phase 1/2 continuation in the US and Australia, data from which are expected as soon as early first quarter 2021.
Two coronavirus vaccines, those made by Pfizer/BioNTech and Moderna, have received emergency use authorization from the US Food and Drug Administration. Two more vaccines, those from Johnson & Johnson and AstraZeneca, are in Phase 3 trials in the United States.
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