Biovac and IVI sign ground breaking deal for the manufacturing of OCV

Biovac, South Africa, has concluded a ground-breaking licensing and technology transfer agreement with the International Vaccine Institute (IVI), South Korea, for the manufacture of an oral cholera vaccine (OCV).

The agreement comes at a time of a cholera outbreak, placing additional demand on already limited supply of cholera vaccines globally. The extent of cholera outbreaks in recent years has escalated, while there has been an increasing gap between supply and demand for cholera vaccines.

The partnership with IVI aims to license and transfer technology to increase production volumes in order to reduce the critical shortage of vaccines needed to prevent cholera globally.

The transfer of technology will also establish and demonstrate capacity for Good Manufacturing Process (GMP) scale-up; local manufacture of clinical trial product and end-to-end production of vaccines in Africa. This is a critical step forward for vaccine production on the continent.

The project is significant for Biovac as it enables the production of the antigen/raw material needed to manufacture actual vaccines. This is one of the remaining steps in the vaccine manufacturing value chain that is currently missing across the African vaccine manufacturing landscape.

The agreement is underpinned by collective support of R120 million ($6.9 million) from Wellcome and the Bill & Melinda Gates Foundation for the first phase of the project. It will allow Biovac to expand its capabilities from filling and packaging of vaccine vials to end-to-end vaccine product development and drug substance manufacture.

Biovac CEO, Dr Morena Makhoana, said “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…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.”

The technology transfer will commence in January 2023, with the first clinical trial batches expected to be produced in 2024 and licensing of the product by the South African National Regulatory Authority (SAHPRA) to be concluded in 2026 alongside WHO Prequalification certification which will follow shortly thereafter.

Makhoana highlighted the importance of achieving pre-qualification from the World Health Organization (WHO). “Through this and other projects, Biovac plans to attain WHO pre-qualification. We will then be well placed to supply UN agencies such as WHO and UNICEF/GAVI as many African countries and other least developed countries source their vaccines through this mechanism.

Director of IVI’s Cholera Program, Dr Julia Lynch, says IVI’s technical know-how and required materials to produce OCV have been transferred to four different manufacturers to date.

“OCV is a proven, highly effective preventive measure against a disease that strikes the most vulnerable. 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 another manufacturer to the marketplace and expand production capacity. With Biovac and the support of the Gates Foundation and Wellcome, we aim to expand the global supply of OCV and prevent cholera worldwide.”

We are proud to be funding this project to build capacity to manufacture this much-needed vaccine and generate a sustainable vaccine supply within the countries that need them most. For the first time in recent history, an affordable life-saving oral cholera vaccine will be made on the African continent, for the African people,” concluded Professor Gordon Dougan, Director of Infectious Diseases at Wellcome Trust.