Researchers and scientists in South Africa launched clinical trials for the country's first domestically developed oral cholera vaccine on Tuesday, marking a historic milestone in the nation's pharmaceutical capabilities. The vaccine, developed by Cape Town-based pharmaceutical firm Biovac, represents the first vaccine to be fully developed and produced locally in over 50 years.
The clinical trials are currently assessing the vaccine's safety in adults and will be followed by comparative studies against existing cholera vaccines already on the market. If successful, the vaccine could be approved and ready for use across Africa by 2028, according to Health Minister Aaron Motsoaledi.
Addressing Critical Global Shortages
The development comes at a crucial time when global cholera vaccine shortages have hampered outbreak responses worldwide. According to the World Health Organization, as many as 4 million people around the world are affected by cholera annually, with between 21,000 and 143,000 deaths occurring each year.
"This development addresses a critical, life-saving need, given the ongoing global shortages of the vaccine amid recurring cholera outbreaks," said Biovac CEO Morena Makhoana. The company has received approval from the South African Health Products Regulatory Authority to begin the oral cholera vaccine (OCV) trials.
Unlike other vaccines manufactured in South Africa that rely on imported active pharmaceutical ingredients, Biovac is manufacturing this vaccine from start to finish. "Vaccines manufactured in South Africa usually rely on active pharmaceutical ingredients imported from abroad, with only the final formulation completed locally," Makhoana explained. "But in this case, Biovac is manufacturing the vaccine from start to finish."
Trial Design and Participants
The trials are being conducted in three provinces - Gauteng, Eastern Cape, and KwaZulu-Natal - where cholera cases have previously been reported. The initial phase involves 40 adult participants, with plans to expand to younger age groups in subsequent phases.
Professor Glenda Gray, the South African Medical Research Council's chief scientific officer and distinguished professor at Wits University's Faculty of Health Sciences, explained the trial's objectives: "Through these clinical trials, we measure antibody responses, how much the vaccine induces an immune response, before we can confirm that it works as well as existing vaccines."
The first phase focuses on adult participants, but future stages will include adolescents and young children, the age group most vulnerable to cholera. "Once we establish safety in adults, we'll move to 17-year-olds, then down to children aged one to six," Gray said. Given South Africa's high HIV burden, the trials will also confirm the vaccine's safety and effectiveness for people living with HIV.
Personal Stakes for Participants
Among the trial participants is Shadrack Makutu, 37, a resident from Limpopo province who has previously experienced cholera outbreaks in his village of Bushbuckridge. "When I was told about the trial, I didn't even have to think about it. I know the devastating effects of cholera. I experienced it in my village, where we have to share water with animals," Makutu said.
He recalled the 2009 outbreak in Mpumalanga that left 19 people dead and received his second dose of the vaccine on Tuesday, reporting no side effects from the first dose.
Another participant, Lerato Maleka, 44, from Diepkloof, Soweto, enrolled due to water quality concerns in South Africa. "I haven't had cholera, but we know that sometimes they don't maintain water and people died in Hammanskraal from cholera by drinking water, so I wanted to be safe from that," Maleka said.
Reducing Vaccine Dependence
The vaccine development has been praised as addressing Africa's vulnerability to supply chain disruptions and vaccine nationalism exposed during the COVID-19 pandemic. Motsoaledi emphasized the strategic importance: "When we can research, develop and manufacture vaccines locally, we reduce our vulnerability to supply chain disruptions, geopolitical pressures, international market competition and vaccine nationalism, which was apparent at the height of the COVID-19 pandemic."
While South Africa experiences relatively low levels of cholera, many African countries are frequently hit hard by outbreaks. A 2023 cholera outbreak in South Africa led to 47 deaths and over 1,400 reported cases, while neighboring countries like Malawi, Mozambique, and Zimbabwe have experienced far higher case numbers and fatalities.
Global Impact Potential
Gray noted that approximately one billion people worldwide are at risk of cholera, with floods, droughts, and natural disasters creating conditions that allow the disease to thrive. "Having a vaccine means protecting people from dying of a preventable disease, and that's why this is so important," she said.
If trials prove successful, South Africa will become the first country on the continent to produce a cholera vaccine, potentially transforming vaccine access across Africa. The development represents what Motsoaledi called "reclaiming our capability" to innovate, manufacture, and protect public health independently of wealthier nations' supply chains.
