Phase 3 clinical trials of the Novavax Covid-19 vaccine are expected to begin in the United States and Mexico, the company announced Monday.
The test for the vaccine candidate, called NVX-CoV2373, assesses safety, efficacy and immune response in up to 30,000 people aged 18 and older. It builds on Phase 1 and 2 studies which showed that the vaccine stimulated an immune response and appeared to be safe.
The test examines whether the vaccine suppresses the moderate symptoms of Covid-19, as well as the very adverse symptoms of Covid-19.
Two-thirds of participants will be assigned to receive two injections of vaccine at random 21 days apart, the other third will receive a placebo. The test sites are in locations that currently have high transmission rates “to accelerate the collection of advanced cases that may demonstrate efficacy,” a statement said.
Novavax states that 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 funded by up to $ 1.6 billion from Operation Warp Speed.
Some background: Novavax is also currently conducting a Phase 3 clinical study in the UK, a Phase 2b trial in South Africa and a Phase 1/2 follow-up in the US and Australia, and data from it is expected as soon as the first quarter 2021.
Two coronavirus vaccines, those made by Pfizer / BioNTech and Moderna, have received emergency use approval from the U.S. Food and Drug Administration. Two other vaccines, those from Johnson & Johnson and AstraZeneca, are in Phase 3 trials in the United States.
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