Johannesburg: Biovac has received approval from the South African Health Products Regulatory Authority (SAHPRA) to begin clinical trials for its oral cholera vaccine. This marks a significant advancement for South Africa, potentially positioning it as the only African country with the capability to fully manufacture this crucial vaccine domestically.
According to South African Government News Agency, Minister of Health Dr. Aaron Motsoaledi described the launch of clinical trials for the country’s first fully manufactured cholera vaccine as a historic milestone. He emphasized that this achievement not only benefits Biovac and South Africa but also holds significance for the entire continent. Dr. Motsoaledi highlighted that the ability to produce a life-saving vaccine locally enhances national capacity to respond swiftly to potential outbreaks and strengthens Africa’s self-reliance in vaccine production. This development aligns with the government’s vision of ensuring health security and universal access to essential medicines.
The Deputy Minister of Science, Technology and Innovation, Dr. Nomalungelo Gina, reiterated the government’s commitment to promoting local manufacturing, facilitating technology transfer, and commercializing scientific discoveries. These efforts are essential for public health, job creation, skills development, and industrial growth, benefiting not only South Africa but the entire African continent. Dr. Gina and Dr. Motsoaledi spoke at the launch of South Africa’s first locally manufactured vaccine in over 50 years, held at the Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg.
The Ministers pointed out that cholera outbreaks have been increasing in Africa, coinciding with repeated shortages of cholera vaccines, leaving vulnerable communities exposed to unnecessary disease and fatalities. Cholera, though preventable, 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 Gates Foundation, Open Philanthropy, the Wellcome Trust in the United Kingdom, and the ELMA Vaccines and Immunisation Foundation. 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 significant leap from the current level of less than 1%.
Phase 1 of Biovac’s oral cholera vaccine clinical trial began at the University of the Witwatersrand’s Perinatal HIV Research Unit (Wits’ PHRU) in October 2025. This initial phase focuses on testing the vaccine’s safety in adults before moving to Phase 3, which will assess its immunogenicity. Phase 3 trials will be conducted at five sites, including two in Johannesburg, two in Durban, and one in East London.
Coordinated by the South African Medical Research Council (SAMRC), the trial underscores South Africa’s capability to conduct trials for multiple product types. If deemed safe in the initial phase, a larger Phase 3 study will compare the Biovac oral cholera vaccine with Euvichol Plus, a cholera vaccine by EuBiologics, currently prequalified by the World Health Organisation (WHO). Depending on the trial outcomes, the vaccine could be approved and ready for use in Africa by 2028 and globally by 2028/29.
Dr. Morena Makhoana, CEO of Biovac, expressed pride in manufacturing the vaccine entirely in South Africa. He noted that if trials are successful, South Africa will become the first country on the continent to produce a cholera vaccine, addressing a critical need given global shortages amid recurring outbreaks.
Biovac, established in 2003 as a collaboration between the government and private sector, is a Cape Town-based biopharmaceutical company focused on revitalizing local vaccine production capabilities.
Professor Glenda Gray, SAMRC Chief Scientific Officer and Distinguished Professor at the Faculty of Health Sciences at Wits University, stated, “We are honored 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 affirmed their commitment to conducting trials in full compliance with good clinical practice guidelines, with utmost regard for participant safety and care.