Johannesburg – South Africa has launched an Oral Cholera Vaccine clinical trial.
“For the first time in history, a vaccine ready for a pivotal clinical trial has been developed and produced from start to finish right here on South African soil,” Health Minister Aaron Motsoaledi said on Tuesday, 11 November 2025.
“This milestone is about reclaiming our country’s capability to innovate, to manufacture vaccines, and to protect the health of our own people, the people of Africa, and global recipients through global procurement processes.”
“In the past, South Africa had limited capacity to produce vaccines locally, and this still continues, with our country relying on imports from other nations.“
However, Minister Motsoaledi said the Covid-19 pandemic exposed the dangers of this dependence, where access to lifesaving vaccines was often determined not by need, but by geography and global inequities.
“Today, we take a decisive step towards changing that story,” he said.
“Building local vaccine manufacturing capability is not a luxury; it is a national necessity.
“It strengthens our sovereignty, enhances our health security, and ensures that our people are not left behind when the next global health crisis strikes.”
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 has 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 a 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.
Commenting on the development, CEO of Biovac, Dr. Morena Makhoana, said: “Biovac is proud to be manufacturing this vaccine entirely in South Africa, the first time in over 50 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.”
According to the World Health Organization, an estimated 1.3 to 4 million people around the world get cholera each year, and 21,000 to 143,000 people die from it.
Cholera outbreaks in South Africa date back to the 1970s, often linked to natural disasters and poor sanitation.
The first confirmed case was reported in 1974, followed by annual outbreaks from 1980 to 1987, leading to over 25,000 cases and 348 deaths.
After the 2023 deadly cholera outbreak in South Africa, the Department of Science, Technology, and Innovation reviewed the 2014 version of the National Cholera Guidelines to align them with the Global Task Force on Cholera Treatment (GFTCC).
The Department’s Decadal Plan (2022–2032) places health innovation at the very centre of South Africa’s science and technology agenda.
Dr. Nomalungelo Gina, Deputy Minister of Science, Technology, and Innovation, said: “This oral cholera vaccine project adds to that growing pipeline of innovation and reflects how government, researchers, and industry are aligning efforts to strengthen Africa’s preparedness against current and future pandemics”.
