South Africa's Biovac initiates clinical trials for first oral cholera vaccine in over 50 years
SAMRC Chief Scientific Officer and Distinguished Professor at the Faculty of Health Sciences, Wits University, Professor Glenda Gray, during a live vaccine administration demonstration.
Image: Supplied
In a landmark development for the nation’s health sector, South Africa is set to produce its first vaccine from scratch in more than half a century.
This is after Biovac received approval from the South African Health Products Regulatory Authority (Sahpra) to begin clinical trials of its oral cholera vaccine.
The clinical trials for Biovac’s oral cholera vaccine were launched on Tuesday at Chris Hani Baragwanath Academic Hospital, Johannesburg.
Cholera outbreaks are increasing in Africa, exacerbated by vaccine shortages that leave communities vulnerable.
The project is supported by several organisations, including the Gates Foundation, Open Philanthropy, the UK's Wellcome Trust, and the ELMA Vaccines & Immunization Foundation.
Health Minister Dr Aaron Motsoaledi addresses attendees at the launch of Biovac’s Oral Cholera Vaccine clinical trials in Johannesburg.
Image: Supplied
In his keynote address, Health Minister Dr Aaron Motsoaledi said local production of oral cholera vaccines will enable South Africa and the continent to respond swiftly, decisively, and equitably for our citizens and our neighbours.
“We firmly believe that strong local and regional science and innovation ecosystems are vital for being prepared to handle outbreaks such as cholera,” Motsoaledi said.
He said the pivotal clinical trials of the oral cholera vaccine are timely. Cholera is a preventable, severe diarrhoeal illness caused by Vibrio cholerae.
“If we have a locally manufactured oral cholera vaccine, it would mean that we will be better equipped to protect vulnerable populations, respond quickly to outbreaks, and save lives,” Motsoaledi said.
Department of Science, Technology and Innovation (DSTI) Deputy Minister Dr Nomalungelo Gina said: “Today’s launch reaffirms our belief that South Africa’s scientific community stands ready to lead Africa’s health innovation agenda. Together, through partnerships such as this one, we will continue to build a future where every African has equitable access to life-saving vaccines made in Africa, for Africa,” Gina said.
Department of Science, Technology and Innovation (DSTI) Deputy Minister Dr Nomalungelo Gina says the oral cholera vaccine project reflects how government, researchers, and industry are aligning efforts to strengthen Africa’s preparedness against current and future pandemics.
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Biovac Chief Executive Officer Dr Morena Makhoana said cholera is afflicting several African countries.
Makhoana noted that the International Vaccine Institute (IVI) provided the base technology.
However, he said it would not be possible without the supporters.
“Biovac is proud to be manufacturing this vaccine entirely in South Africa, the first time in over 50 years that such a milestone has been achieved. If the trials are successful, South Africa will become the first country on the continent to produce a cholera vaccine. This development addresses a critical, life-saving need, given the ongoing global shortages of the vaccine amid recurring cholera outbreaks,” Makhoana said.
Makhoana highlighted South Africa’s critical vaccine ecosystem, noting existing contributions like research funding allocations, while acknowledging shortcomings.
He added that collaboration with the South African Medical Research Council (SAMRC), universities, and the South African government was essential.
Makhoana stated the locally produced vaccine received SAHPRA approval for clinical trials and its manufacturing facility (drug substance), obtaining a first-ever GMP (Good Manufacturing Practice) certificate for South Africa’s drug substance capability.
SAHPRA also approved the clinical trial design, developed with the SAMRC and IVI. Full licensing is contingent on successful trial completion.
He said that when the product is licensed, they hope to get World Health Organization (WHO) pre-qualification (WHO assesses the quality, safety, and efficacy of medicinal products).
Makhoana stated the product will be licensed and registered locally after completion, and they are willing to supply it to the South African government for outbreaks or stockpiles. Major UN agencies like UNICEF and Gavi are also pushing for increased cholera vaccine manufacturing for the worst-hit countries.
SAMRC Chief Scientific Officer and Distinguished Professor at the Faculty of Health Sciences, Wits University, Professor Glenda Gray, said: “We are honoured to lead the clinical trials for the oral cholera vaccine, a historical landmark for our country and a vital step in strengthening our country’s ability to respond to infectious diseases.
“The SAMRC has extensive experience in designing and conducting clinical trials, and this project aligns with our mandate to drive research and innovation that improves the health and well-being of all South Africans. We are committed to ensuring that these trials are conducted in full compliance with Good Clinical Practice guidelines, with the highest regard for the safety, care, and protection of all participants.”