Active Infection & Immunity Public Health & Healthcare

Towards the launch of Biovac’s OCV-S in Africa and beyond

Funder Wellcome Charity-funded
Recipient organisation Biovac Institute Source-published name: The Biovac Institute
Funding £9.0M
Period May 2025 — Jan 2028

In plain English

AI plain-English summary

Biovac is preparing to launch Africa’s first end-to-end manufactured oral cholera vaccine, moving from technology transfer to full production. This matters because the world faces a critical shortage of oral cholera vaccines, and Africa currently has no capacity to produce them from start to finish. Without local manufacturing, the continent depends entirely on partners outside Africa for drug substance manufacture—a cycle this project aims to break. The work addresses both a supply gap and a structural dependency in global health infrastructure. If successful, Biovac’s vaccine will undergo regulatory approval and World Health Organization prequalification, opening access to GAVI-funded markets. The project also builds regulatory capability within Africa’s broader ecosystem, creating a measurable foundation for future vaccine development on the continent. For everyday life, this could mean a reliable, locally produced vaccine reaching communities during cholera outbreaks, rather than waiting on shipments from abroad. For the systems that quietly keep society running—supply chains, manufacturing processes, and regulatory frameworks—this establishes a new node of production and expertise in Africa, reducing vulnerability to global shortages.

View original technical description
Biovac entered a technology transfer partnership with International Vaccine Institute (IVI) in 2022 for the development and manufacture of an oral cholera vaccine (OCV). This transfer addresses the critical global shortage of OCV and establishes the first end-to-end vaccine manufacturing capacity in Africa. The overall OCV project consists of the following stages: 1\. Phase 1 (Complete): Technology transfer from IVI. 2\. Phase 2 (2024-2027): Clinical development, licensure, and product launch, including WHO PQ to access GAVI markets. 3\. Phase 3 (2025 onward): The construction of a large-scale facility to produce 60+ million doses annually. This funding application is an extension of Phase 2 with the goal of preparing for product launch. The funding will support the completion of process optimization, manufacture of validation batches, dossier submission to SAHPRA and WHO PQ, operational readiness for product launch and market shaping activities for successful regulatory launch. Advancing a vaccine candidate from process development through to licensure will provide a measurable basis for building such capacity at Biovac and within the broader ecosystem within Africa, especially with respect to regulatory capability. Ultimately building such capacity will lead to breaking the cycle of dependency on partners outside of Africa for drug substance manufacture.

View the original record at the funder ↗

Researchers

Seanette Wilson (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

Advancing the establishment of Capacity for Vaccine Product Development through the Manufacture of OCV-S for Clinical Development in Africa
Establishing Marburg Vaccine Development and Manufacturing Capability in Africa: Collaboration between Public Health Vaccines (PHV) and Institut Pasteur de Dakar (IPD) for the Technology Transfer of PHV’s Clinical-Stage rVSV Marburg Vaccine Candidate
Molecular farming in African biomanufacturing: A UK-Southern Africa partnership for enhancing vaccine production and biosecurity capacity
Cholera control in endemic regions of Africa: assessing mass preventative OCV campaigns impacts and strategies
Development of a Prophylactic Ebola Vaccine Using an Heterologous Prime-Boost Regimen: Phase II - Sofia ref.: 115861

Original classification

Discretionary Award

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