SA Launches First Locally Made Oral Cholera Vaccine Trials

South Africa has reached a historic milestone in public health, with Biovac receiving approval from the South African Health Products Regulatory Authority (SAHPRA) to begin clinical trials for the country’s first locally manufactured oral cholera vaccine.

This breakthrough positions South Africa as the only country in Africa capable of producing this life-saving vaccine entirely in-house — a significant step towards the continent’s goal of vaccine self-reliance.

Minister of Health Dr Aaron Motsoaledi hailed the development as a moment of national pride.

“The ability to manufacture a life-saving vaccine from start to finish right here at home strengthens our 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,” he said.

Deputy Minister of Science, Technology and Innovation Dr Nomalungelo Gina echoed these sentiments, reaffirming government’s commitment to local manufacturing, technology transfer, and commercialisation of scientific innovation.

“These efforts are vital not only for public health but also for job creation, skills development, and industrial growth — not just for South Africa, but for Africa,” she said.

The launch event, held at Chris Hani Baragwanath Academic Hospital in Soweto, marked the first locally manufactured vaccine in over 50 years. Both ministers highlighted the urgency of the project, noting the increasing frequency of cholera outbreaks across Africa and the shortage of vaccines that has left many communities vulnerable.

Cholera is a preventable disease that can be fatal during outbreaks if treatments such as oral rehydration therapy, antibiotics, and vaccines are unavailable.

The Biovac vaccine development project is supported by the Bill & Melinda Gates Foundation, Open Philanthropy, the Wellcome Trust (UK), and the ELMA Vaccines and Immunisation Foundation.

The African Union (AU) aims for 60% of routine vaccines used in Africa to be manufactured on the continent by 2030, a massive leap from the current figure of less than 1%.

Phase 1 of the Biovac trial began in October 2025 at the University of the Witwatersrand’s Perinatal HIV Research Unit (Wits PHRU). This stage focuses on testing the vaccine’s safety in adults, followed by Phase 3, which will assess its ability to generate immunity against cholera. Trials will take place at five sites — two in Johannesburg, two in Durban, and one in East London — coordinated by the South African Medical Research Council (SAMRC).

If successful, the vaccine will be compared with Euvichol-Plus, a WHO-approved cholera vaccine produced by EuBiologics. Pending positive outcomes, approval for use in Africa could come by 2028, with global availability expected in 2028/29.

Biovac CEO Dr Morena Makhoana expressed pride in the achievement.

“If the trials succeed, 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 global vaccine shortages and recurring outbreaks,” he said.

Founded in 2003 through a public-private partnership, Biovac has been at the forefront of rebuilding South Africa’s vaccine manufacturing capacity.

Professor Glenda Gray, Chief Scientific Officer at SAMRC and a Distinguished Professor at Wits University, described the trial as a landmark moment.

“We are honoured to lead the clinical trials for this vaccine. It represents a vital step in strengthening our national response to infectious diseases, conducted with the highest ethical and safety standards,” she said.