Clinical trials testing the efficacy of the first locally manufactured oral cholera vaccine, developed by Biovac, were officially launched on Tuesday, reports TimesLIVE – which if successful, will make South Africa the first country on the continent to manufacture the vaccine entirely from start to finish.
Co-ordinated by the South African Medical Research Council (SAMRC), the trials will take place across various sites, including KwaZulu-Natal and the Eastern Cape.
Phase 1 of was launched at the University of the Witwatersrand’s PHRU in October and will focus on testing safety in adults.
If successful, a phase 3 study will assess the vaccine’s ability to trigger protective antibodies at five sites across Johannesburg, Durban and East London.
SAMRC chief scientific officer and distinguished Professor at Wits University Professor Glenda Gray emphasised the urgent global need for an oral cholera vaccine.
“Today, about a billion people worldwide are at risk of cholera. With floods, droughts and other natural disasters disrupting access to clean water, the risk only increases. Having a vaccine will protect people from dying of cholera of the disease,” she said.
Gray added that the trials represent a vital step in strengthening the country’s ability to respond to infectious diseases.
“We are honoured to lead the clinical trials for the Oral Cholera Vaccine, a historical landmark for our country.”
Welcoming the initiative, Health Minister Aaron Motsoaledi said: “Building local vaccine manufacturing is not a luxury; it is a mission of necessity. It strengthens our sovereignty, enhances our health security and ensures that our people are never left behind.”
He described the launch as a powerful statement of intent, one that seeks to restore South Africa’s vaccine manufacturing capacity.
“In the past, South Africa had limited capacity to produce vaccines locally, relying heavily on imports from other nations.
“The Covid-19 pandemic exposed the dangers of this dependence, where access to life-saving vaccines was determined not by need but by geography and global inequities. We are changing that story.”
Unlike most vaccines manufactured locally, which rely on imported ingredients for the final “fill and finish,” Biovac’s vaccine is being developed end-to-end, from initial bacterial strains through to manufacturing and clinical trials.
Biovac CEO Dr Morena Makhoana said the vaccine addresses a critical, life-saving need amid global shortages, reports IOL.
“Biovac is proud to be manufacturing this vaccine entirely in South Africa, the first time in more than 50 years that such a milestone has been achieved. If the trials are successful, South Africa will become the first country on the continent to produce a cholera vaccine,” she said.
Deputy Minister of Science, Technology & Innovation Dr Nomalungelo Gina said the government remained committed to advancing local manufacturing and technology transfer.
"Projects like this exemplify how government, researchers, and industry are working together to strengthen Africa’s ability to respond to health threats.”
The news comes as state-backed Biovac has launched a new product development laboratory at its Cape Town facility to expand the company’s ability to develop vaccines and other therapeutics, and to strengthen its capacity to produce shots from start to finish.
The country’s key distributor of childhood vaccines has, over the past 20 years, gradually stepped up its manufacturing capacity, working back along the value chain from packaging to formulating and filling syringes, reports Business Day.
It now plans to develop the active ingredients for novel vaccines at its new facility in Pinelands, where scientists will conduct research and development on potential shots for disease-causing bacteria, viruses and parasites, said CEO Dr Morena Makhoana.
“No other facilities in Africa have this capacity,’ he told Business Day. He declined to disclose the scale of the investment in the new facility, which is backed by the Gates Foundation.
The lab represented a leap forward for vaccine innovation and manufacturing in Africa, said Gates Foundation CEO Mark Suzman, and for millions of people, heralds the promise of “faster, more reliable access to lifesaving vaccines, developed and produced in Africa, for Africa”.
African vaccines
Biovac is among a handful of vaccine manufacturers in Africa still relying on imports for 99% of its needs. In 2022, the AU set a target of ensuring that 60% of vaccines used in Africa were manufactured on the continent by 2040. Biovac’s new laboratory will enable multiple products to be developed at the same time, and will initially target diseases prevalent in Africa, said Makhoana.
The facility includes infrastructure for mRNA drug substance development, screening, evaluation and manufacturing. It contains a specialised suite to formulate nanoparticles to encapsulate mRNA, along with dedicated areas for bacterial and cell culture, cell bank storage, and handling sensitive materials.
Makhoana added that the goal is to develop vaccines used in routine immunisation programmes as well as those used to combat disease outbreaks.
In addition to the oral cholera vaccine, it last year signed deals with pharmaceutical giant Sanofi and South Korean firm EuBiologics to produce their shots for polio and meningitis.
These deals built on its long-standing import and distribution agreement with the national Health Department for childhood vaccines, and a prior manufacturing agreement with Sanofi to make its six-in-one jab Hexaxim and Pfizer’s anti-pneumonia shot Prevnar.
BusinessLIVE – Biovac launches product development lab in Cape Town
See more from MedicalBrief archives:
Desperate countries face world shortage of 50m cholera vaccines
Oral cholera vaccine to be produced by SA’s Biovac
African-made vaccines vital to help develop pandemic resilience