Science, Technology and Innovation on start of trials of life-saving oral cholera vaccine

Cape Town based Biovac has received approval from the South African Health Regulatory Products Authority (SAHPRA) to begin clinical trials of its Oral Cholera Vaccine, a breakthrough that could make South Africa, the only African country to manufacture this life-saving vaccine from end to end.

The Oral Cholera Vaccine development highlights Biovac’s evolution from a vaccine distributor to a full-scale manufacturing hub and showcases South Africa’s growing capability to produce life-saving medical innovations and vaccines. Vaccines manufactured in South Africa usually receive the active pharmaceutical ingredient from abroad with the final vaccine being completed in South Africa (often referred to as ‘fill and finish’), but in this case, the vaccine candidate is being manufactured from start to end by Biovac. The end-to-end process refers to the innovation of developing the vaccine from the initial bacterial strains all the way through to the manufacturing process and then undergoing clinical trials and regulatory approval.

The number of cholera outbreaks have been growing in Africa, coinciding with repeated shortages of cholera vaccines, leaving exposed communities vulnerable to unnecessary disease and deaths. Cholera, a preventable disease, can be fatal during outbreaks if treatments, such as oral rehydration therapy, antibiotics and vaccines to curb the spread, are unavailable. 

Biovac’s innovation marks a milestone in Africa’s ability to produce vaccines for itself, reducing reliance on limited global supply and ultimately saving lives. 

The Biovac vaccine development project is supported by the Gates Foundation, Open Philanthropy, the UK’s Wellcome Trust, and the ELMA Vaccines & Immunization Foundation, among others. 

The African Union has set a target for 60% of all routine vaccines used in Africa to be manufactured on the continent by 2030, a major advancement from today’s level of less than 1%. Biovac’s achievement represents tangible progress towards this goal.   

Phase 1 of Biovac’s Oral Cholera Vaccine clinical trial was launched at the University of the Witwatersrand's (Wits) PHRU, awell-known and established clinical trial site, in October 2025, and will focus on testing safety in adults, before proceeding to a further Phase 3 of the clinical trial, assessing the immunogenicity (which indicates that the vaccine can prevent cholera through antibodies developed in patients who receive the vaccine).  

The Phase 3 trial will be conducted at five sites, two in Johannesburg, two in Durban, and one in East London. Coordinated by the South African Medical Research Council, this clinical trial also highlights South Africa’s ability to conduct trials for multiple types of products. This is a critically important component of being able to develop and manufacture such products locally.   

If the vaccine is deemed safe in the first phase of the trial, in the larger Phase 3 study, the Biovac Oral Cholera Vaccine will be compared to Euvichol Plus, a cholera vaccine from EuBiologics, which is one of several oral cholera vaccines currently prequalified by the World Health Organisation. Depending on the trial outcomes, the Oral Cholera Vaccine could be approved and ready for use in Africa in 2028 and globally by 2028/2029.    

Gavi, the Vaccine Alliance, a private-public partnership, that supplies half the world’s childhood vaccines, has put incentives in place for African-made vaccines, putting Biovac in a strong position to secure market share and making it a front runner in the bid to sell the vaccine to African countries and those who need it.   

Biovac successfully received and implemented the technology to manufacture the Oral Cholera Vaccine after it entered into a technology transfer partnership in 2022 with the International Vaccine Institute in South Korea.

Founded initially as an innovative and forward-looking public–private partnership with the South African government, Biovac has steadily expanded its capabilities over two decades. It supplies and produces some vaccines used in South Africa’s Expanded Programme on Immunisation, protecting children against deadly and serious diseases such as measles, polio, and hepatitis B, amongst others.

Minister of Health, Dr Aaron Motsoaledi said: “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. The ability to manufacture a life-saving vaccine from start to finish right here at home strengthens our national capacity to respond swiftly to potential outbreaks and enhances Africa’s self-reliance in vaccine production. This milestone aligns with the government’s vision of ensuring health security and universal access to essential medicines.”  Minister Motsoaledi added, “I commend Biovac and all partners involved for their contribution to protecting the health and lives of our people.” 

The Deputy Minister of Science, Technology and Innovation, Dr Nomalungelo Gina said government remained committed to advancing local manufacturing, technology transfer, and the commercialisation of scientific discoveries, vital not only for public health but also for job creation, skills development, and industrial growth. Not only for the benefit of South Africa, but for Africa. 
“Guided by the Department of Science, Technology and Innovation’s Decadal Plan (2022–2032), which prioritises health innovation and vaccine manufacturing, 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.”

CEO of Biovac Dr Morena Makhoana said: “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. This development addresses a critical, life-saving need, given the ongoing global shortages of the vaccine amid recurring cholera outbreaks”    

Professor Glenda Gray, SAMRC Chief Scientific Officer and Distinguished Professor at the Faculty of Health Sciences, Wits University 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.” 

Duncan Steele, Deputy Director for Enterics, Diagnostics, Genomics & Epidemiologyat 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.”

Jacob Trefethen, Program Director, Global Health & Wellbeing at Open Philanthropy: "Open Philanthropy is proud to support Biovac's efforts to manufacture an oral cholera vaccine entirely in South Africa — this achievement represents an important step toward ensuring reliable vaccine access on the continent and globally. We commend Biovac's dedication to advancing from technology transfer to end-to-end production and look forward to the clinical trial results that could bring this life-saving vaccine to those who need it most."

Florian von Groote, Head of Clinical Research, Infectious Disease, at Wellcome, said, “This clinical trial could be a major step in strengthening the African vaccine manufacturing landscape, showing that local manufacturers can make vaccines that meet the needs of communities on the continent. Through long-term support and investment, local manufacturing can deliver accessible and affordable vaccines made by Africa, for Africa.”  

Bernadette Moffat, Executive Director, ELMA Philanthropies Services (Africa) said: “This clinical trial and Biovac’s ability to manufacture the vaccine represents an important milestone in Africa’s journey to health security. Critical health products, such as the cholera vaccine, need to be manufactured and stockpiled locally to prevent outbreaks spiralling out of control.”

For media enquiries:
Biovac
Katharine Child kath@resolvecommunications.co.za or 083 5667223

SAMRC  
Tendani Tsedu (SAMRC) at tendani.tsedu@mrc.ac.za or 082 945 1980 

Department of Science and Technology and Innovation
Veronica Mohapeloa (Media liaison officer to the Deputy Minister) at veronica.mohapeloa@dsti.gov.za or 083 400 5750

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