Aug 17 (Reuters) – US drug developer Novavax Inc said on Monday that it is launching a mid-term study of its experimental COVID-19 vaccine in South Africa as the country experiences an increase in coronavirus cases.
The Phase 2b trial of NVX-CoV2373 will be performed on approximately 2,665 healthy adults and will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults, the company said in a statement reut.rs/3g0sRzb.
“As South Africa experiences a winter uprising of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373,” said Gregory Vice President Novavax Glenn.
South Africa is the fifth worst country with 583,653 cases of coronavirus and 11,677 deaths, according to a Reuters census.
The Bill & Melinda Gates Foundation is providing a $ 15 million grant for the clinical trial, the company said.
Novavax said it intends to initiate the Phase 2 part of this trial in the near future and that it would include around 1,500 candidates.
Earlier this month, Glenn told Reuters that the company would soon begin much larger clinical trials in the late stages and could potentially take over enough data to get regulatory approvals by December.
The U.S. government had allocated Novavax $ 1.6 billion in July to test and manufacture a potential vaccine for the novel coronavirus in the United States, with the goal of delivering 100 million doses by January.
Last month, AstraZeneca said that late-stage tests of its experimental drug AZD1222, developed by AstraZeneca and Oxford University, are taking place in Brazil and South Africa and are due to begin in the United States, where the prevalence is higher. (Report by Sabahatjahan Contractor in Bengaluru; Edited by Amy Caren Daniel)
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