By Russell Rensburg
In March 2024, a pivotal clinical trial was launched to evaluate what might well become the first new tuberculosis vaccine on the market in more than a century. As anticipation mounts for the trial to deliver results, Russell Rensburg argues that we need to start preparing for a rollout of the jab, but that we should think of preparation more widely than just the technicalities of regulatory approval and drug supply.
Over the past few weeks, there have been ongoing discussions about a potential new TB vaccine coming to South Africa.
The leading new vaccine candidate M72/AS01E TB or M72 for short is currently being evaluated in a large phase three clinical trial that started in March 2024. The trial has been running ahead of schedule and it is possible that results might be ready in the next year. If those results are positive, registration with the South African Health Products Regulatory Authority should follow quite soon after.
As all this happens, preparations for possible future manufacturing of the jab are already underway. In July, the Serum Institute of India announced an agreement with the Gates Medical Research Institute to prepare for large-scale production should the trial be successful and the vaccine approved.
And at the same time South Africa’s National Department of Health has started to engage in discussions about the roadmap for a possible vaccine rollout.
The optimism is high, and rightly so. It’s the first time in more than 100 years that we have reached this point with a new TB vaccine. Given the size of South Africa’s population at approximately 63 million people, its share of TB deaths worldwide is striking. WHO data shows that of the over 1.2 million TB deaths, around 54 000 were reported in South Africa. The idea that a new jab can arrest the alarming death rate of this curable disease and change the trajectory of TB in the country is exciting.
But the point that we are at should also prompt an urgent question. If a new TB vaccine proves successful, will South Africa actually be ready to use it?
For a country carrying one of the world’s highest TB burdens, a successful vaccine could fundamentally change our response to the disease. But the regulatory approvals that we will hopefully see next year or the year after would only be the beginning.
Getting community buy-in
To effectively roll out this vaccine, South Africa would need the buy-in of communities who trust that this vaccine could help them and are willing to encourage their fellow community members to take it up.
This negotiation could be harder than we think.
The country does not have to wait for the vaccine to be approved to begin this work. The opportunity to start building the community trust already exists. How? With the current rollout of a new TB test.
The National Department of Health is implementing a demonstration project to assess the health system’s readiness to introduce a new near point-of-care TB diagnostic test into the public healthcare system. The test would mean that people can get TB tests done at the clinic and get a result virtually immediately.
Many of South Africa’s TB deaths are due to late diagnosis. The new test presents the opportunity to shorten the gap between testing and diagnosis (samples don’t have to be sent off to labs) and could result in earlier initiation into care, which will potentially contribute to reduced mortality.
The near point-of-care testing sites are being deployed across the country in district hospitals, community health centres and primary healthcare clinics.
But a very important part of that work is not simply understanding whether the health system is ready for this diagnostic approach, it’s how communities are engaged and mobilised to understand and use it.
Testing community engagement
The community mobilisation and demand-creation component allows us to work directly with communities to understand what it takes to introduce a new TB intervention in a way that does not simply place a new technology into the health system and assume that people will use it.
Alongside measuring diagnostic performance, we should be deliberately testing models of community engagement: working with community health workers, TB survivors, civil society organisations and trusted local leaders; building people’s understanding of TB; listening to their concerns; identifying misinformation early; and understanding which messages, platforms and messengers people trust.
If we do this well, when a TB vaccine eventually becomes available, we will not be starting the conversation from zero. We will already have communities that have been part of the journey of TB innovation, systems for listening and responding to their concerns, and trusted people who can help communities navigate new information. That is what genuine vaccine preparedness should look like. It is not only preparing the regulatory pathway, procurement systems and cold chain. It is preparing the people and communities for whom the vaccine is ultimately intended.
Yet community engagement is too often treated as something that happens at the end of the process: develop the intervention, approve it, procure it and then ask civil society to persuade people to use it.
Trust cannot be manufactured through a communications campaign launched three months before rollout. Trust in a vaccine is inseparable from trust in the health system delivering it. That is why community investment should be considered part of vaccine preparedness itself—not an optional communications budget added later.
The civil society bridge
Civil society has a particularly important role here. Government develops policy, researchers generate evidence and health workers deliver services. Civil society often provides the bridge between those systems and communities.
Community organisations understand local languages, stigma, misinformation, barriers to accessing care and, importantly, the questions people may be reluctant to ask government or healthcare providers.
We should therefore begin strengthening community systems now: building the capacity of trusted community leaders; developing TB vaccine literacy; establishing mechanisms for community-led monitoring; and integrating conversations about vaccination into existing TB, HIV and primary healthcare services.
This is not about convincing people to take a vaccine that has not yet been approved. It is about creating the conditions in which people can eventually make informed decisions.
Ultimately, the measure of success will not be how quickly South Africa approves or procures a new TB vaccine. It will be whether the people who stand to benefit from it understand it, trust the systems delivering it, and are able and willing to access it.
The scientific breakthrough may happen in a laboratory. But whether it changes the trajectory of TB in South Africa will be decided in our communities.
– Rensburg is divisional director of the Rural Health Advocacy Project, which hosts the TB Accountability Consortium.
Disclosure: This piece was published by Spotlight – health journalism in the public interest. The Gates Medical Research Institute mentioned in this article is a non-profit organisation and subsidiary of the Gates Foundation. Spotlight receives funding from the Gates Foundation but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.
