Homegrown cholera vaccine trials bring hope to rural communities

In Shadrack Makutu’s village in Bushbuckridge, Mpumalanga, residents still share water sources with livestock, a daily risk that leaves them vulnerable to waterborne diseases such as cholera.

So when Makutu was approached to take part in South Africa’s first oral cholera vaccine (OCV) clinical trials, he didn’t hesitate. For him, it was a chance to protect his community from a disease that has claimed too many lives.

Makutu, 37, now living in Johannesburg, is one of 40 participants in the country’s first clinical trials for a locally manufactured oral cholera vaccine, developed by Biovac and launched on Tuesday at Chris Hani Baragwanath Academic Hospital.

According to Biovac, cholera outbreaks have been increasing across Africa, often coinciding with repeated global shortages of vaccines, leaving already exposed communities even more vulnerable to preventable disease and death.

The launch marks a major milestone for South Africa: it is the first time in more than 50 years that a vaccine has been fully developed and produced locally. It also represents a crucial step towards vaccine self-reliance and a stronger, faster response to infectious disease outbreaks that continue to affect vulnerable communities.

In 2023, a cholera outbreak claimed more than 40 lives, mainly in Hammanskraal and the surrounding areas of Tshwane. For Makutu, the memory of cholera’s devastation is personal.

“When I was told about the trial, I didn’t even have to think about it. I know the devastating effects of cholera. I experienced it in my village, where we have to share water with animals,” he said.

He recalled the 2009 outbreak in Mpumalanga that left 19 people dead. On Tuesday, he received his second dose of the vaccine.

“I had no side effects from the first dose. We just have to stay healthy because they monitor our vitals every time we come in,” he said.

Makutu was joined by another participant, Lerato Maleka, 44, from Diepkloof, who said she volunteered because she wanted to protect herself and her family in case of another outbreak.

“I saw how people died from cholera two years ago, and it scared me. Sometimes our water isn’t clean, and I can’t take chances with my life,” she said.

Testing for safety and immunity

Professor Glenda Gray, the South African Medical Research Council’s (SAMRC) chief scientific officer and a distinguished professor at Wits University’s Faculty of Health Sciences, explained that the trial is assessing the vaccine’s safety and immune response.

“Through these clinical trials, we measure antibody responses, how much the vaccine induces an immune response, before we can confirm that it works as well as existing vaccines,” she said.

“This data is what’s required for registration. When we apply for market authorisation, we must show that the vaccine performs just as well as others already in use.”

The first phase of the trial involves adult participants, but Gray said future stages will include adolescents and young children, the age group most vulnerable to cholera.

“Once we establish safety in adults, we’ll move to 17-year-olds, then down to children aged one to six. We also have a high HIV burden in our country, so it’s important to confirm that the vaccine is safe and effective for people living with HIV,” she said.

A homegrown solution to a global problem

Gray said the vaccine’s development was driven by global need.

“About a billion people worldwide are at risk of cholera,” she noted.

“Floods, droughts and natural disasters displace people and disrupt access to clean water, conditions that allow cholera to thrive. Having a vaccine means protecting people from dying of a preventable disease, and that’s why this is so important.”

She added that clinical sites have already been established in KwaZulu-Natal and the Eastern Cape to ensure a representative sample across the country.

“We are testing both the safety and the immunogenicity of the vaccine, in other words, how well it triggers protective immunity,” Gray said.

A milestone for Biovac and South Africa

Biovac CEO Dr Morena Makhoana said the company has received approval from the South African Health Products Regulatory Authority to begin the OCV trials.

“Vaccines manufactured in South Africa usually rely on active pharmaceutical ingredients imported from abroad, with only the final formulation completed locally,” he explained. “But in this case, Biovac is manufacturing the vaccine from start to finish.”

Vaccine resistance has existed since the first vaccines were developed. Some people oppose them on religious grounds, while others simply seek attention by spreading misinformation.

—  Dr Aaron Motsoaledi, health minister

If the trials prove successful, South Africa will become the first country on the continent to produce a cholera vaccine.

“This development addresses a critical, life-saving need,” Makhoana said. “Global shortages have hampered outbreak response in recent years, and local production will help ensure Africa’s access to vaccines when they’re needed most.”

‘Reclaiming our capability’

Health minister Dr Aaron Motsoaledi hailed the launch as a historic achievement.

“For the first time in our history, a vaccine ready for pivotal clinical trials has been developed and produced from start to finish right here on South African soil,” he said.

Motsoaledi said the milestone was about reclaiming the country’s capability to innovate, manufacture and protect the health of our people and of Africa more broadly.

He added that for too long, South Africa had been reliant on imports from wealthier nations.

“The Covid-19 pandemic exposed the dangers of this dependence, where access to life-saving vaccines was often determined not by need but by geography and global inequality,” he said.

He added that every country must be prepared to handle disease outbreaks through strong local ecosystems.

“To be truly ready, every country must have access to three critical tools, diagnostics, therapeutics and vaccines,” he said.

“Diagnostics allow for early detection and containment, therapeutics save lives by reducing disease severity, and vaccines prevent outbreaks before they spread.”

Addressing vaccine hesitancy

Motsoaledi also acknowledged that vaccine hesitancy remains a global challenge.

“Vaccine resistance has existed since the first vaccines were developed. Some people oppose them on religious grounds, while others simply seek attention by spreading misinformation,” he said.

He recalled how, during earlier polio campaigns, resistance in four countries, Pakistan, Afghanistan, India and Nigeria, had been so strong that the World Health Organization coined the acronym ‘PAIN’.

“But that pain is gone,” he said.

“Even during Covid-19 we faced similar resistance, and yet vaccines saved millions of lives. Some people are still waiting for those of us who were vaccinated to drop dead, but the reality is that vaccines helped bring us to where we are today.”

For South Africa, the launch of locally made cholera vaccine trials is more than a scientific milestone; it’s a statement of intent. It signals the country’s readiness to take ownership of its public health future and to ensure that lifesaving tools are accessible to all, not just to those who can afford them.

And for participants like Shadrack Makutu, it’s a moment of pride and hope.

“If this vaccine can help save lives, especially back home where people still share water with animals, then it’s worth it,” he said.