A vial of a potential COVID-19 vaccine is raised at Novavax laboratories in Gaithersburg, Maryland on March 20. Andrew Caballero-Renyolds / AFP / Getty Images
The phase 3 clinical trials with the Novavax Covid-19 vaccine are scheduled to begin in the United States and Mexico, the company announced on Monday.
In the study for the vaccine candidate NVX-CoV2373, safety, efficacy and immune response are assessed in up to 30,000 people aged 18 and over. It builds on Phase 1 and 2 studies that showed the vaccine elicited an immune response and appeared safe.
The study looks to see if the vaccine prevents moderate Covid-19 symptoms as well as severe Covid-19 symptoms.
Two-thirds of the participants will receive two vaccine injections at random, 21 days apart, the remaining third will receive a placebo. The trial sites are in locations with currently high transmission rates “to accelerate the accumulation of positive cases that could show effectiveness,” it said in a statement.
According to Novavax, at least 25% of the study population should be 65 years or older, at least 15% black, at least 10 to 20% Latinx and 1-2% Indians.
The study is funded with up to $ 1.6 billion from Operation Warp Speed.
Some background information: Novavax is also currently conducting a Phase 3 clinical trial in the UK, a Phase 2b trial in South Africa and a Phase 1/2 sequel in the US and Australia, with data expected as early as the first quarter of 2021.
Two coronavirus vaccines made by Pfizer / BioNTech and Moderna have received emergency 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 US.
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