State-backed vaccine manufacturer Biovac and the SA Medical Research Council (MRC) have launched a cholera vaccine clinical trial, with hopes running high that it will help reduce Africa’s reliance on imported pharmaceuticals and shore up limited global supplies.
Cholera vaccine stocks ran so low during a resurgence of the disease in 2022 that the World Health Organisation recommended halving the two-dose regimen to try to protect more people. At that stage the only company manufacturing cholera vaccines for outbreaks was EuBiologics, which was unable to meet demand.
If Biovac’s candidate oral cholera vaccine proves safe and effective, it will be the first product it manufactures from start to finish, including the active pharmaceutical ingredients. It marks an important milestone for the organisation, which was launched in 2003 to re-establish SA’s human vaccine manufacturing capacity. It began with distribution and packaging, and then progressed to formulating, filling and finishing vaccines for other pharmaceutical manufacturers, such as Sanofi and Pfizer.
Biovac’s latest achievement stems from a licensing and technology transfer agreement signed with the South Korean International Vaccine Initiative in 2022.
If the candidate vaccine proves successful, SA will become the first country in Africa to manufacture a cholera vaccine, said Biovac CEO Morena Makhoana. “This development addresses a critical, life-saving need, given the ongoing global shortages of the vaccine amid recurring cholera outbreaks.”
The candidate vaccine is a clear liquid administered with a dropper, he said.
This development addresses a critical, life-saving need, given the ongoing global shortages of the vaccine amid recurring cholera outbreaks.
— Morena Makhoana, Biovac CEO.
Cholera is a bacterial disease contracted by ingesting contaminated water or food, or from direct contact with someone who is infected. While most cases are mild, cholera can quickly progress to a serious illness that can cause severe dehydration and lead to death within hours.
SA has recorded intermittent cholera outbreaks since the 1970s, triggered by imported cases. In 2023, a cholera outbreak in Hammanskraal resulted in more than 100 hospitalisations and more than 30 deaths.
Researchers will begin with a phase 1 trial to test the safety of the candidate vaccine in 40 adult volunteers. If all goes well, the next step will be a phase 3 trial comparing the immune system response it elicits with that generated by EuBiologics’ vaccine, Euvichol Plus. The pool of volunteers will be gradually expanded to include younger people, with the ultimate aim to provide it to children as young as one, said principal investigator Glenda Gray, chief scientific officer at the MRC.
The trial is expected to enrol about 3,000 volunteers, including people living with HIV, she said.
“We are hoping that once we have the results and submit the dossier to the SA Health Products Regulatory Authority for approval, it will be a priority review, which means we could get it registered by the end of next year,” said Gray.
The vaccine will be affordable for the countries that need it most, she said.
Biovac is expected to make use of the $1bn package announced by the global vaccine alliance Gavi last year to support African vaccine manufacturers. The African Vaccine Manufacturing Accelerator will provide milestone payments and pay a premium per dose to help emerging African vaccine manufacturers compete with well-established players such as the Serum Institute of India.
Health minister Aaron Motsoaledi said the development strengthened SA’s capacity to respond swiftly to potential outbreaks and enhanced Africa’s self-reliance in vaccine production. “This milestone aligns with the government’s vision of ensuring health security and universal access to essential medicines,” he said.
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