Biovac partnership to increase African vaccine manufacturing capabilities

South African biopharma company Biovac signs a partnership deal with the International Vaccine Institute to develop and manufacture an oral cholera vaccine for both the African and global market. 

Biovac, a biopharmaceutical company created through a partnership with the South African government in 2003, was established in response to a lack of human vaccine manufacturing capabilities on the African continent. The licensing and technology transfer project will fill a crucial step in the vaccine manufacturing value chain in the African vaccine manufacturing sector by providing drug substance manufacturing capabilities and the production of antigens/raw materials required in vaccine manufacturing. In partnership with IVI, Biovac aims to license and transfer technology to increase vaccine production volumes to respond to a shortage of cholera vaccines required not only in the continent of Africa, but globally. The project will also aim to demonstrate a capacity for GMP scale-up, as well as local manufacturing of clinical trial products and end-to-end vaccine production in Africa.  

Cholera remains an ongoing issue for nations such as Pakistan, Nigeria, and Malawi, further aggravated by climate change, armed conflicts, and displacement. With a limited supply of global cholera vaccines, outbreaks in recent years have increased to the point where there remains a significant gap between the supply and demand for vaccines. CEO of Biovac, Morena Makhoana, stated: “It became clear that increasing self-sufficiency is important if Africa is to have better control over its own public health and vaccine supply chains.” Some African leaders have committed to the creation of an indigenous vaccine industry, with hopes of boosting vaccine manufacturing shares to 60% in 2040.  

IVI’s Cholera Program Director Julia Lynch stated: “Oral cholera vaccine is a proven, highly effective measure against a disease that strikes the most vulnerable... We are thrilled to partner with Biovac to complete a technology transfer of [oral cholera vaccine] that will add another manufacturer to the marketplace and expand production capacity.” 

“This initiative will be the beginning of end-to-end manufactur[ing] at Biovac, while at the same time addressing an ongoing and increasing cholera disease burden globally. In addition, this feeds directly into Biovac’s facilities expansion plan to scale up production capacity and will most likely be the first product (drug substance and drug product) to be manufactured in our new facility when it comes on line,” Makhoana commented. 

The project is set to comment in January 2023, with clinical trial batches to be produced in 2024. Licensing is aimed to conclude in 2026 by the South African National Regulatory Authority along with the WHO Prequalification certification. It is collectively supported by the Wellcome Trust and the Bill & Melinda Gates Foundation totalling USD $6.9 million. 

Source: Biovac-IVI-OCV-Technology-Transfer-Press-Release-23-Nov-2022.pdf