South Africa begins trials for first fully manufactured oral cholera vaccine
Biovac has received approval from the South African Health Products Regulatory Authority (SAHPRA) to begin clinical trials of its Oral Cholera Vaccine, making South Africa the first African country to manufacture the vaccine entirely from start to finish.
Minister of Health Dr Aaron Motsoaledi described the milestone as historic, saying it strengthens the country’s capacity to respond to outbreaks and enhances Africa’s self-reliance in vaccine production.
“The commencement of clinical trials for South Africa’s first fully manufactured Oral Cholera Vaccine is a historic milestone, not only for Biovac and our nation, but for the entire continent,” he said.
Phase 1 of the clinical trial was launched at the University of the Witwatersrand’s (Wits) PHRU in October 2025 and will focus on testing safety in adults.
If successful, a Phase 3 study will assess the vaccine’s ability to trigger protective antibodies at five sites across Johannesburg, Durban, and East London, coordinated by the South African Medical Research Council.
Unlike most vaccines manufactured locally, which rely on imported ingredients for the final “fill and finish,” Biovac’s vaccine is being developed end-to-end, from initial bacterial strains through to manufacturing and clinical trials.
Biovac CEO Dr Morena Makhoana said the vaccine addresses a critical, life-saving need amid global shortages.
“Biovac is proud to be manufacturing this vaccine entirely in South Africa, the first time in over fifty 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,” she said.
Professor Glenda Gray of SAMRC said the trials represent a vital step in strengthening the country’s ability to respond to infectious diseases.
“We are honoured to lead the clinical trials for the Oral Cholera Vaccine, a historical landmark for our country.
”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,” she said.
Deputy Minister of Science, Technology and Innovation Dr Nomalungelo Gina, said government remained committed to advancing local manufacturing and technology transfer.
”Projects like the oral cholera vaccine exemplify how government, researchers, and industry are working together to strengthen Africa’s ability to respond to health threats.”
International partners supporting the project include the Gates Foundation, Open Philanthropy, Wellcome Trust, and ELMA Vaccines & Immunization Foundation.
Duncan Steele from the Gates Foundation said, “At a time of unprecedented cholera outbreaks and suffering, particularly in Africa, the Gates Foundation is extremely pleased to be partnering with Biovac to produce a vaccine for use in Africa to ameliorate the suffering we are seeing across the continent.”
If trials succeed, the vaccine could be approved for use in Africa by 2028 and globally by 2028/2029.
The Phase 3 study will compare Biovac’s vaccine to Euvichol Plus, a WHO-prequalified oral cholera vaccine.
Biovac’s ability to manufacture the Oral Cholera Vaccine follows a 2022 technology transfer agreement with the International Vaccine Institute in South Korea.
The project reflects two decades of growth for Biovac and aligns with the African Union’s target of producing 60% of routine vaccines on the continent by 2030, a major leap from today’s level of less than 1%.
hope.ntanzi@iol.co.za
IOL News