SAHPRA gives Biovac go-ahead to start oral cholera vaccine trials
Following the recent opening of its new product development laboratory in Cape Town, the South African Health Products Regulatory Authority (SAHPRA) has given Biovac approval to begin clinical trials for its oral cholera vaccine. This is a significant development that could position South Africa as the only African country to manufacture this life-saving vaccine entirely in-house.
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Minister of Health Dr Aaron Motsoaledi described the start of clinical trials for the country’s first fully manufactured cholera vaccine as a historic milestone, not just for Biovac and South Africa, 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,” said Motsoaledi.
The Deputy Minister of Science, Technology and Innovation, Dr Nomalungelo Gina, said the government is committed to promoting local manufacturing, facilitating technology transfer, and commercialising scientific discoveries.
These efforts are essential 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,” said Gina.
Motsoaledi and Gina addressed the launch of South Africa’s first locally manufactured vaccine in over 50 years.
The event took place at the Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg.
The ministers said 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.
Vaccine development
The Biovac vaccine development project receives support from the Gates Foundation, Open Philanthropy, the Wellcome Trust in the United Kingdom, and the ELMA Vaccines and Immunisation Foundation, among others.
The African Union (AU) 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%.
Phase 1 of Biovac’s oral cholera vaccine clinical trial was initiated at the University of the Witwatersrand’s Perinatal HIV Research Unit (Wits’ PHRU), a renowned and established clinical trial site, in October 2025.
The first phase will focus on safety testing in adults, before proceeding to a further Phase 3 of the clinical trial —i.e. immunogenicity, which assesses whether 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 (SAMRC), this clinical trial also highlights South Africa’s ability to conduct trials for multiple product types.
Euvichol Plus
If the vaccine is deemed safe in the Phase 1 trial, a larger Phase 3 study will compare the Biovac oral cholera vaccine with Euvichol Plus, a cholera vaccine produced by EuBiologics.
Euvichol Plus is one of several oral cholera vaccines that are currently prequalified by the World Health Organisation (WHO).
Depending on the trial outcomes, the vaccine could be approved and ready for use in Africa in 2028 and globally by 2028/29.
Biovac CEO Dr Morena Makhoana said the organisation is proud to be manufacturing this vaccine entirely in South Africa.
“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,” said Makhoana.
Biovac is a biopharmaceutical company based in Cape Town, established in 2003 as a result of a collaboration between the government and private sector aimed at revitalising local vaccine production capabilities.
SAMRC chief scientific officer and distinguished professor at the Faculty of Health Sciences, Wits University, Professor Glenda Gray, 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.”
She said they were 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.