Biovac Begins Clinical Trials for First Locally Oral Cholera Vaccine

This marks a pivotal step in positioning South Africa as the only country in Africa capable of producing this life-saving vaccine entirely in-house — from research and development to production.

South Africa has achieved a groundbreaking milestone in public health and biotechnology as the South African Health Products Regulatory Authority (SAHPRA) granted approval to Biovac to commence clinical trials for the nation’s first fully locally manufactured oral cholera vaccine. This marks a pivotal step in positioning South Africa as the only country in Africa capable of producing this life-saving vaccine entirely in-house — from research and development to production.

A Historic Milestone for Africa’s Vaccine Independence

Health Minister Dr Aaron Motsoaledi hailed the development as a defining moment for South Africa and the continent. Speaking at the launch event held at the Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg, Motsoaledi emphasized the broader implications of this achievement for African health sovereignty.

“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,” he stated.

The minister added that this initiative directly aligns with the government’s vision to ensure universal access to essential medicines and bolster health security in the region.

Government Commitment to Science, Innovation, and Industrial Growth

Deputy Minister of Science, Technology and Innovation, Dr Nomalungelo Gina, reaffirmed the government’s dedication to promoting domestic pharmaceutical manufacturing and supporting scientific innovation through technology transfer and commercialization.

“This effort is not only for South Africa but for the benefit of Africa,” she said, highlighting how the initiative will contribute to job creation, skills development, and the growth of the local biotech industry.

Addressing Cholera Outbreaks and Vaccine Shortages

The initiative comes at a critical time when Africa has been facing repeated cholera outbreaks alongside global vaccine shortages. Cholera, a preventable waterborne disease, remains deadly when treatments and vaccines are unavailable. Motsoaledi emphasized that this vaccine could drastically reduce deaths in vulnerable communities and help prevent future epidemics.

The Biovac project enjoys robust international support from global partners including the Bill & Melinda Gates Foundation, Open Philanthropy, the Wellcome Trust (UK), and the ELMA Vaccines and Immunisation Foundation. This collaboration underscores the shared global goal of strengthening Africa’s health resilience.

Africa’s 2030 Vision for Vaccine Manufacturing

The African Union (AU) has set an ambitious target for 60% of all routine vaccines used across the continent to be manufactured locally by 2030 — a significant leap from the current level of less than 1%. Biovac’s progress marks an essential step toward realizing this vision and making Africa a major contributor to global vaccine production.

Clinical Trials: A Multi-Phase Process

The clinical trial process began in October 2025 at the University of the Witwatersrand’s Perinatal HIV Research Unit (PHRU), one of South Africa’s leading clinical research centers.

• Phase 1 focuses on testing the vaccine’s safety among adult volunteers.

• Phase 3, to be coordinated by the South African Medical Research Council (SAMRC), will assess immunogenicity — determining whether the vaccine effectively triggers protective antibodies against cholera.

This phase will take place at five sites: two in Johannesburg, two in Durban, and one in East London. If the vaccine is proven safe and effective, it will be compared against Euvichol Plus, a WHO-prequalified cholera vaccine developed by EuBiologics, during larger-scale testing.

Toward 2028: A Vision for African Vaccine Readiness

Should the trials yield positive outcomes, Biovac’s oral cholera vaccine could be ready for African deployment by 2028 and for global distribution by 2029. Biovac CEO Dr Morena Makhoana expressed optimism about the potential impact of this milestone:

“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 amid recurring global shortages.”

Leadership and Scientific Excellence

Founded in 2003 as a public-private partnership, Biovac was established to rebuild South Africa’s vaccine production capabilities after decades of decline. The company’s achievements reflect a resurgence of local expertise in advanced biotechnology and pharmaceutical manufacturing.

Professor Glenda Gray, Chief Scientific Officer at SAMRC and Distinguished Professor at Wits University, highlighted the significance of the project for medical science and national pride:

“We are honoured to lead the clinical trials for the oral cholera vaccine, a historic landmark for our country and a vital step in strengthening our ability to respond to infectious diseases.”

She affirmed that the trials would adhere to the highest international ethical and scientific standards, ensuring safety and integrity throughout every stage.

A Step Toward Health Security and Economic Empowerment

Beyond its immediate public health benefits, the initiative promises long-term socioeconomic advantages. Local vaccine manufacturing reduces dependency on international suppliers, ensures faster response during epidemics, and creates a sustainable ecosystem for scientific innovation.

This achievement symbolizes more than just scientific progress—it represents Africa’s determination to reclaim agency in global health, transforming its role from vaccine importer to producer.