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The company in a statement signed on Monday by Gregory M. Glenn, president of Research and Development at Novavax stated that the trial will evaluate the efficacy of a COVID-19 vaccine candidate, according to local media.
He stated that Dr Shabir Madhi, a professor of Vaccinology at Wits University, will lead the clinical trial which is supported in part by a $15 million grant from the Bill & Melinda Gates Foundation.
Gleen said, “South Africa is experiencing a winter surge 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.”
He also stated that the trial would consist of two cohorts, noting that the first cohort would evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults, while second cohort would evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults.
Gleen noted that if the COVID-19 vaccine is approved, it would ultimately be supplied in the country through a recently announced collaboration with the Serum Institute of India.
Madhi, who expressed his excitement and optimism to work as the principal investigator in the clinical trial said COVID-19 vaccine’s positive Phase 1 data will provide strong rationale for moving development forward in a larger subset of adults.
“The major motivation for the Covid-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own,” said Madhi
Gleen, however, appreciated the continued support of the Bill & Melinda Gates Foundation and CEPI, saying that the ongoing collaboration with Wits University will produce and deliver a safe, effective vaccine across the globe.”