South African-based bio-pharmaceutical company, Biovac, has concluded a ground-breaking licensing and technology transfer agreement to manufacture an oral cholera vaccine (OCV).

According to a statement released on Wednesday, this is a partnership with the International Vaccine Institute (IVI), a non-profit international organisation headquartered in South Korea.

“The project is significant for Biovac as it enables drug substance manufacturing capability to be built, that is, production of the antigen or raw material needed to manufacture actual vaccines,” the company said.

“This is one of the remaining steps in the vaccine manufacturing value chain that is currently missing, not only at Biovac but across the African vaccine manufacturing landscape.”

The company, which is partly owned by the South African government, said the agreement comes at a time when cholera outbreaks are wreaking havoc on fragile health systems in Pakistan, Nigeria and Malawi.

“This places additional demand on already-limited supply of cholera vaccines globally.”

According to Biovac, the extent of recent cholera outbreaks has escalated while there has been an increasing gap between supply and demand for cholera vaccines.

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

Biovac believes that after many decades, this will be a critical step forward for vaccine production in Africa.  

“This is in a market in Africa where less than 1% of vaccines are locally manufactured and where infectious diseases are still the leading cause of death, especially in children under five years.”

The agreement is underpinned by collective support of R120 million ($6.9 million) from Wellcome Trust and the Bill & Melinda Gates Foundation for the first phase of the project.

This 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 the COVID-19 pandemic exposed Africa’s lack of local production capacity.

“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.”

For African vaccine manufacture to be sustainable, Makhoana said the continent needs to ensure that research and development, technology transfers, scale-up, drug substance manufacture and licensing all take place on African soil.

“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 process will commence in January 2023, with the first clinical trial batches expected to be produced in 2024.

Meanwhile, the licensing of the product by the South African National Regulatory Authority (SAHPRA) is expected to be concluded in 2026 alongside World Health Organisation (WHO) prequalification certification.

“Through this and other projects, Biovac plans to attain WHO pre-qualification. We will then be well placed to supply United Nations agencies such as WHO and UNICEF/GAVI as many African countries and other least developed countries source their vaccines through this mechanism.”

The Director of IVI’s Cholera Program, Dr Julia Lynch, said the 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. 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.”

IVI Director-General, Jerome Kim, believes that maintaining a global supply of the cholera vaccine is critical for preventing cholera and controlling outbreaks.

President of the Bill & Melinda Gates Foundation’s Global Health Program, Trevor Mundel, said the foundation is excited to support this important project to increase access to lifesaving oral cholera vaccines.

Director of Infectious Diseases at Wellcome Trust, Professor Gordon Dougan, said the tools needed to control cholera exist, a combination of good epidemiology, water management and vaccines.

However, what is urgently needed, according to Dougan, is to increase access to an affordable, effective vaccine to meet the growing demand.