The only tuberculosis vaccine we have is a century old and offers only limited efficacy in children. With leading South African researchers involved in the pivotal clinical trials of three new tuberculosis vaccine candidates, we are on the verge of a major breakthrough, writes Associate Professor Angelique Kany Kany Luabeya.
My uncle died of abdominal TB a few days ago, after facing repeated challenges in getting an accurate diagnosis. For him, the treatment started much too late. To many in his community, my uncle was a respected teacher, a breadwinner, a pillar of support and strength.
In 2026, why are people still dying from a preventable disease that continues to cause unnecessary deaths and hardship?
Why we urgently need a new TB vaccine should be obvious. For the millions who are sick, and for families living with the catastrophic loss of a loved one, the need is painfully clear.
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Prior to the emergence of the SARS-CoV-2 virus, TB was the world’s deadliest infectious disease, killing more than 1.5 million people every year. While COVID-19 has since shown an epidemic downturn, TB’s toll remains devastatingly high.
Globally, an estimated 2 billion people are infected with the Mycobacterium tuberculosis that causes TB in humans. In this state, also known as latent TB infection, they do not have TB symptoms and are non-infectious, but the bacteria remain dormant in their bodies. Of these people, about 5 to 10% will go on to develop active TB when their immune system is no longer able to contain the bacteria. This means that they now have TB disease, sometimes without noticeable symptoms, and risks passing it to others. This could be a family member, a friend, or a stranger who happens to be nearby.
TINY BUT PERSISTENT | What do ancient Egyptian mummies, George Orwell, and over 10 million people around the world have in common? Surprisingly, the answer is TB. Find out more: shorturl.at/xuHfB
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TB bacteria have coexisted with humans for millions of years. There is a cure, but treatment alone is not enough to stop transmission. TB mostly affects countries with limited resources because patients struggle to access care or are unable to complete treatment due to side effects or a lack of food to support the rigorous regimen of drugs they must take to cure them. In addition, the rise of multidrug-resistant tuberculosis is now fueling a global health crisis.
In South Africa, recent data from the World Health Organization’s (WHO) Global TB Report indicate progress, with a 57% reduction in new TB cases since 2015. However, TB mortality is still high and is concentrated mainly in poor and vulnerable communities. According to the WHO, TB still claims over 50 000 lives in South Africa every year. The burden is also unevenly distributed, with some geographic areas affected more than others.
A vaccine which prevents TB
Our hopes are now pinned on developing an efficacious vaccine which prevents people from developing TB disease. WHO modelling suggests that a vaccine which prevents most people with latent TB infection from progressing to active disease would have the most rapid impact on the epidemic in high-burden countries.
The most urgent priorities for protection would be people living with HIV, healthcare workers at risk of workplace exposure, adolescents and young adults who are driving transmission, as well as those with comorbidities such as diabetes that increase their risk of TB diseases and negatively affect treatment outcomes.
The COVID-19 pandemic proved that when human survival is threatened, the scientific community can respond with breathtaking speed, developing multiple effective vaccines in under a year. Sadly, the urgency and resources allocated to finding an effective TB vaccine do not match the scale of its devastation.
For more than a century (since 1921), we have had only one licensed TB jab, which is the bacillus Calmette-Guérin (BCG) vaccine that is given at birth. Despite its limitations in preventing TB that infects the lungs – the main route of transmission – BCG remains a critical tool because it protects millions of babies from more serious forms of TB that can spread through the blood to the brain. But, clearly, the BCG vaccine is not enough.
Hope is on the horizon though, with several novel TB vaccines now in late-stage clinical trials. New vaccines or drugs are evaluated clinically in humans in steps, or phases, for safety, immunogenicity, and efficacy.
The most advanced is M72/AS01E (M72 for short), which is an adjuvanted subunit vaccine under development by the Gates Medical Research Institute and GlaxoSmithKline. In a phase 2 trial, this vaccine showed close to 50% efficacy in preventing TB disease in TB-infected people–the first time a vaccine has achieved this level of efficacy. A pivotal phase 3 trial of this vaccine has now completed enrolment of 20 000 volunteers, including 13 000 people in South Africa, with results expected in 2028. Developers typically apply for registration with regulatory authorities after successful phase 3 trials – so this study is the last big hurdle for this vaccine.
Another promising candidate is the MTBVAC vaccine, a live, whole, attenuated Mycobacterium tuberculosis vaccine developed by Biofabri, in partnership with the University of Zaragoza and sponsored by the International AIDS Vaccine Initiative. It is in a multi-country phase 2b trial in adults and adolescents and a phase 3 trial in newborns, including in South Africa.
BioNTech’s mRNA TB vaccine is also being evaluated in a phase 2a study in South Africa. Funded by BioNTech, this vaccine candidate harnesses mRNA technology, which has proved successful in the COVID-19 response.
Paving the way for acceptance and use
South African researchers are at the forefront of these TB vaccine efforts. Our strengths lie in our robust clinical trial capacity, world-class institutions, commitment to equitable solutions, and regulatory expertise, all of which help accelerate vaccine licensure. As a global policy leader, South Africa co-chairs the Finance and Access Working Group at the WHO TB Vaccine Accelerator Council, advocating for fair distribution and sustainable financing, and has recently co-hosted a vaccine preparedness workshop to position the country for the emergence of late-stage TB vaccines.
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But the most important aspect to consider is the vaccine’s acceptability and uptake by a myriad of population groups at risk of TB. We learned from COVID-19 how misinformation can devastate vaccine uptake, leading to unnecessary morbidity and mortality. Confidence in new TB vaccines must be built to maximise impact. The context may be different–TB is an old, well-known enemy that affects people close to us. By involving South African communities in the early stages of vaccine trials, we can ensure their priorities are part of the development agenda.
While we continue to improve TB diagnosis and treatment, the hunt for an effective vaccine continues. After a century of fighting TB with only one vaccine and several antibiotics, we might be on the verge of a breakthrough that could finally shift the trajectory of this ancient and deadly disease.
*Associate Professor Angelique Kany Kany Luabeya is the clinical investigator on the M72 TB vaccine trials being conducted at the South African Tuberculosis Vaccine Initiative based at the University of Cape Town.
Disclosure: 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.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
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