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South Africa Makes History with Africa’s First Fully Made Oral Cholera Vaccine
A Scientific First for the Continent
South Africa has officially launched clinical trials for the continent’s first fully manufactured oral cholera vaccine, marking a major breakthrough for local science and public health. The vaccine is being developed by Biovac, a Cape Town-based biopharmaceutical company, with full approval from the South African Health Products Regulatory Authority (SAHPRA).
Until now, most vaccines produced in Africa have depended on imported ingredients for the final packaging stages. Biovac’s new project is different; it’s homegrown from start to finish, from the initial bacterial strains to the final dose ready for use.
Health Minister Dr Aaron Motsoaledi called it a historic milestone that strengthens the nation’s capacity to tackle outbreaks and boosts Africa’s self-reliance in vaccine manufacturing. “This is a proud moment for South Africa and the continent. It reflects years of investment, innovation, and commitment to ensuring we can respond to our own health challenges,” he said.
The Trial Begins
The first phase of the trial started in October 2025 at the University of the Witwatersrand’s Perinatal HIV Research Unit (PHRU), focusing on safety testing in adults. If successful, the process will move to Phase 3, assessing how effectively the vaccine produces protective antibodies across multiple sites in Johannesburg, Durban, and East London, coordinated by the South African Medical Research Council (SAMRC).
SAMRC President Professor Glenda Gray described the trials as a landmark in local research capacity. “We are proud to lead these trials with the highest ethical and scientific standards, ensuring the safety and care of all participants,” she said.
A Homegrown Answer to Global Shortages
Cholera remains a serious public health threat across Africa, with outbreaks regularly affecting communities lacking access to clean water and sanitation. Global vaccine shortages have left many countries vulnerable.
Dr Morena Makhoana, CEO of Biovac, said the vaccine represents both a scientific and humanitarian achievement. “It’s been over fifty years since South Africa last achieved something of this magnitude in vaccine development. This project will allow us to address a life-saving need at a time of global scarcity,” she said.
The vaccine’s production follows a 2022 technology transfer agreement between Biovac and the International Vaccine Institute in South Korea, designed to build long-term vaccine manufacturing capability within Africa.
Local Innovation, Global Collaboration
The initiative is supported by international health partners, including the Bill & Melinda Gates Foundation, Open Philanthropy, Wellcome Trust, and ELMA Vaccines & Immunization Foundation.
Duncan Steele, speaking for the Gates Foundation, said, “At a time of unprecedented cholera outbreaks, we are proud to partner with Biovac to produce a vaccine made in Africa, for Africa.”
If the trials are successful, the vaccine could be approved for use in Africa by 2028, with global rollout expected soon after. The Phase 3 study will compare Biovac’s vaccine against Euvichol-Plus, the World Health Organisation-approved oral cholera vaccine currently in use.
A Leap Towards Africa’s Health Independence
Deputy Minister of Science, Technology and Innovation Dr Nomalungelo Gina said the government views the vaccine as proof of what is possible when science and policy align. “Projects like this demonstrate how research, innovation, and local industry can come together to strengthen Africa’s response to future health threats,” she said.
The initiative supports the African Union’s 2030 goal of producing 60% of the continent’s routine vaccines locally, up from less than 1% today.
For South Africa, the start of these clinical trials signals more than scientific progress. It’s a promise that the continent’s next generation of vaccines will not just be used here but made here too.
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Source: IOL
Featured Image: Central News South Africa
