Advancing the establishment of Capacity for Vaccine Product Development through the Manufacture of OCV-S for Clinical Development in Africa

Biovac, a South African vaccine manufacturer, is building the capacity to produce oral cholera vaccine for clinical trials in Africa, starting with a technology transfer from the International Vaccine Institute (IVI). The COVID-19 pandemic exposed Africa's near-total dependence on imported vaccines. This project directly addresses that vulnerability by establishing a complete vaccine development and manufacturing pipeline on the continent, from lab-scale demonstration through to World Health Organization prequalification. Cholera remains a persistent threat across Africa, with outbreaks occurring regularly in regions with poor water and sanitation infrastructure. If successful, Biovac will become a licensed supplier of oral cholera vaccine to Gavi and UNICEF, securing a reliable African source for a vaccine that is currently in short supply globally. The project covers the first three stages: demonstrating the IVI technology in the lab, preparing the active pharmaceutical ingredient facility for scale-up, and then scaling up the manufacturing process. Later stages will involve Good Manufacturing Practice production of clinical trial material, clinical studies, South African licensure, and WHO prequalification. The final step will transfer the process to a new large-scale manufacturing facility yet to be built.