SOUTH AFRICA – State-backed vaccine manufacturer Biovac Institute has signed a licensing and technology transfer deal with the International Vaccine Institute (IVI) to develop and make oral cholera vaccine for African and global markets.
The deal with the South Korean non-profit organisation comes as a surge in cholera outbreaks around the world has heightened awareness of a long-standing global constraint on the supply of vaccines.
The partnership with non-profit IVI aims to boost output and reduce vaccine shortages amid a spate of global outbreaks that spurred the World Health Organization (WHO) to temporarily change its dosage regime.
Cholera is a potentially deadly disease spread by eating or drinking food or water contaminated with the faeces of those infected person. Outbreaks often happen in disaster-hit areas or poorer communities lacking proper water and sanitation services.
In the African context, less than 1% of vaccines are locally manufactured and infectious diseases are still the leading cause of death, especially in children under five years.
Notably, African leaders have committed to creating an indigenous vaccine industry, with the goal of boosting the share of vaccines manufactured in Africa from 1% in 2021 to 60% in 2040.
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.
“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,” its Chief Executive Morena Makhoana said in a statement.
He said technology transfer would start in January next year, with the first clinical trial batches expected in 2024, ahead of licensing by domestic regulators and WHO pre-qualification certification.
“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,” he said, regarding the WHO certification.
The deal is supported by 120 million rands (US$7 million) from the Wellcome Trust and the Bill and Melinda Gates Foundation for the first phase of the project.
It will allow Biovac to expand its capabilities beyond filling and packaging of vials to end-to-end vaccine product development and drug substance manufacture.
“We are thrilled to partner with Biovac to complete a technology transfer of oral cholera vaccine (OCV) that will add another manufacturer to the marketplace and expand production capacity,” said Julia Lynch, director of IVI’s cholera program.
Climate change, armed conflict and displacements have added to the risk of cholera outbreaks including in Haiti, Pakistan, Nigeria and Malawi.
Biovac has been ramping up its ability to make vaccines and in September produced its first batch of Covid-19 shots.
This was part of an arrangement to fill and package as many as 100 million doses a year of Pfizer and BioNtech’s inoculation.