South African biopharmaceutical company Biovac and South Korea-based international nonprofit organisation the International Vaccine Institute (IVI) jointly announced in Cape Town on Wednesday that they had concluded a licensing and technology transfer agreement. This agreement, which they described as “ground-breaking”, would allow Biovac to manufacture IVI’s oral cholera vaccine (OCV).

“This initiative will be the beginning of end-to-end vaccine manufacture at Biovac, while at the same time addressing an ongoing and increasing cholera disease burden globally,” highlighted Biovac CEO Dr Morena Makhoana. “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.”

This agreement is, for its first phase, receiving financial support totalling $6.9-million (R120-million) from the Wellcome Trust and the Bill & Melinda Gates Foundation. This will allow Biovac to build a drug substance (the antigens and raw materials necessary to produce vaccines) manufacturing capability. Currently, no facility in Africa has the capability to manufacture these substances. At the moment, Biovac is limited to filling and packaging vaccine vials.

However, the Covid-19 pandemic showed that Africa needed its own vaccine manufacturing capability and African leaders have committed themselves to creating this capability. And recently, there has been an upsurge in cholera outbreaks in both Asia (for example, in Pakistan) and Africa (for example, Malawi and Nigeria).

“OCV is a proven, highly effective preventive measure against a disease that strikes the most vulnerable,” pointed out IVI Cholera Programme director Dr Julia Lynch. “Enthusiastic uptake of the vaccine by countries has resulted in a demand that exceeds current supply, and the supply shortage has been made worse amid an increasing number of cholera outbreaks in 2022. We are thrilled to partner with Biovac to complete a technology transfer of OCV that will add yet another manufacturer to the marketplace and expand production capacity.”

The process of transferring the technology will start in January and the first vaccine batches for clinical trials should be manufactured in 2024. The product licensing process, by the South African Health Products Regulatory Authority (SAHPRA), should be completed in 2026. In parallel, Biovac will seek to achieve pre-qualification status from the World Health Organisation (WHO). It hopes to attain WHO pre-qualification also in 2026, shortly after gaining the product licence from SAHPRA. This would allow it to supply the WHO and other United Nations agencies.