The trial for the vaccine candidate, known as NVX-Covey 2373, will evaluate safety, efficacy, and immune response to 30,000 people aged 18 and over. It builds on phase 1/2 studies showing that the vaccine responds immunely and appears to be safe.
The trial is investigating 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 their second injection.
Two-thirds of the participants will be assigned to receive two injections of the vaccine given within 21 days, the remaining one-third will receive a placebo. The publication states that trial sites are located in sites that currently have high transmission rates “to accelerate the accumulation of positive cases that may show effectiveness,” the publication says.
NovavX says that at least 25% of the study population should be 65 years of age or older, at least 15% black, at least 10 to 20% Latino and 1-2% American Indian.
“With the global Covid-19 epidemic, this is a test step in building a global portfolio of safe and effective vaccines to protect the world’s population,” said Stanley C. Ark, president and chief executive officer of NoviVax. “A news release.
The trial is being funded from Operation Operation Warm Speed to 6 6 1.6 billion.
Novavax is currently conducting a Phase 3 clinical study in the United Kingdom, a Phase 2B trial in South Africa and a Phase 1/2 in the US and Australia Australia, with data expected as early as the first quarter of 2021.
Two Pfizer / Biontech and Modernna vaccines have been launched in the US. Emergency use has been approved by the Food and Drug Administration. The two arrived in the U.S. in July. Started Phase 3 trials in and registered more than 30,000 participants. Both are two-dose vaccines and have been shown to have an efficacy of 95% and 94.1%, respectively.
AstraZeneca launched its coronavirus vaccine Phase 3 U.S. in September. The trial began. Johnson, who has tested the single dose vaccine, and Johnson are expecting results from its Phase 3 trial by January or February.
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