WITS University launched its second vaccine trial on Monday.
The Phase 2 trial in South Africa will evaluate if the nanoparticle S-protein, in the COVID-19 vaccine known as NVX-CoV2373, protects against the virus in adults aged 18-64-years-old.
South Africa is the fifth worst affected country with more than 583 000 coronavirus cases and just under 12 000 deaths.
US drug developer Novavax expects its vaccine, once approved, would be supplied to South Africa through a deal signed earlier this year with the Serum Institute of India to develop and commercialize NVX-CoV2373.
“NVX-CoV2373 is produced by the biotech company, Novavax (Maryland, U.S.A). Novavax is a late-stage biotechnology company that develops next-generation vaccines for serious infectious diseases,” said Wits Professor of Vaccinology, Shabir Madhi.
Madhi is leading the clinical trial in South Africa after having engaged personally with Novavax to motivate for clinical development of the vaccine.
“The major motivation for 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.
The Phase 2 trial in the country is set to enrol about 2 900 volunteers aged 18 to 64-years-old.
Madhi said this would enable informed decision-making when advocating for the adoption of this [NVX-CoV2373 vaccine candidate] or other COVID-19 vaccines in African countries once they are shown to be safe and effective.
“Participating in the clinical development of these vaccines at the outset will assist in advocating for South Africans to be amongst the first in line to access these life-saving vaccines, once they become available.”
President and CEO of Novavax, Stanley Erck, said: “This important Phase 2 clinical trial will not only provide additional data on safety and immunogenicity of NVX-CoV2373, it also has the potential to provide an early indication of efficacy, as South Africa is experiencing a surge of COVID-19.”
The Bill & Melinda Gates Foundation awarded Novavax a $15 million grant towards the COVID-19 vaccine efficacy trial in South Africa.
The South African study is part of a larger, global clinical programme to evaluate NVX-CoV2373, including larger Phase 3 studies with approximately 30 000 participants, to be launched throughout the world.
According to REUTERS, Novavax intends to begin Phase 2 of the small clinical trial in the United States and Australia in the near future and said it would include about 1,500 candidates. It also aims to begin Phase III as soon as late September.
The US government in July awarded Novavax valued over R27bn to cover testing its potential coronavirus vaccine in the United States and manufacturing with the aim of delivering a 100 million doses by January.
(COMPILED BY INSIDE EDUCATION STAFF)