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

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.