A new tuberculosis vaccine designed to protect adolescents and adults could eventually become available in South Africa, with the National Department of Health now preparing for its possible introduction if ongoing international trials prove successful.
Known as M72/AS01E, the vaccine candidate is currently undergoing Phase 3 trials in South Africa, Kenya, Zambia, Malawi and Indonesia.
However, it has not yet been approved, registered or made available to the public.
If successful, it could represent the most significant advance in TB vaccination in more than a century, particularly in a country where an estimated 270,000 people developed TB and approximately 56,000 died from the disease during 2023.
Confirming the development on Sunday, 2 August 2026, the National Department of Health said it was undertaking preparatory work to ensure timely access if the clinical trial produces successful results and the vaccine clears the necessary regulatory processes.
According to the Department, earlier Phase 1 and Phase 2 studies produced promising findings.
Describing its potential importance, the Department said an effective vaccine for adolescents and adults could be a “game-changer for TB control and elimination”.
The proposed vaccine differs from the Bacille Calmette-Guérin vaccine, more commonly known as BCG, which has been used for more than 100 years and is routinely administered to babies.
BCG helps protect young children against severe forms of TB but provides limited protection against pulmonary TB later in life. M72/AS01E is being developed to help prevent pulmonary TB disease among adolescents and adults, addressing a longstanding gap in protection.
A Phase 2b trial found that M72/AS01E demonstrated approximately 50% efficacy against laboratory-confirmed pulmonary TB among participating adults who were infected with the TB bacterium, did not have active TB disease and were HIV-negative.
In practical terms, vaccinated participants were about half as likely to develop active pulmonary TB as those who received the placebo. However, this does not mean that the vaccine would provide complete protection against TB infection or disease.
The larger Phase 3 study must now determine whether those earlier findings can be confirmed while collecting more comprehensive information about the vaccine’s safety, immune response and effectiveness across different groups.
A 2026 scientific paper detailing the Phase 3 trial design explained that its primary objective is to confirm protection among HIV-negative participants who test positive for TB infection.
The study is also assessing safety and immune response among other groups, including people living with HIV.
Researchers modelled a trial involving approximately 18,000 TB-infected participants, divided between the vaccine and control groups. Because the study is event-driven, researchers must wait for a predetermined number of confirmed TB cases before they can reliably determine how much protection the vaccine provides.
The modelling projected that reaching the first principal assessment point could take approximately three-and-a-half to four years.
There is consequently no confirmed date for approval or public rollout.
Even if the Phase 3 trial succeeds, M72/AS01E will still need to undergo regulatory assessment and be registered by the South African Health Products Regulatory Authority before it can be administered outside the clinical-trial environment.
The country’s National TB Recovery Plan 4.0 shows why the development is being watched closely.
According to the plan, an estimated 270,000 people developed TB during 2023, including approximately 13,000 people with drug-resistant TB. More than half of the notified TB patients were also living with HIV, while an estimated 56,000 people died from the disease during the same year.
South Africa remains among the 30 countries carrying the highest burdens of TB, HIV-associated TB and drug-resistant TB.
While the TB incidence rate has declined substantially since 2015 and treatment coverage has improved, deaths have not fallen at the same pace. The Department also reported that more than half of TB-affected households continue to face severe financial pressure when accessing care.
The World Health Organisation places the country’s TB incidence at approximately 427 cases per 100,000 people, underlining the continued scale of the epidemic despite improvements in diagnosis and treatment.
TB is caused by bacteria and most commonly affects the lungs. It spreads through the air when a person with active pulmonary TB coughs, sneezes or speaks, with the risk increasing during prolonged exposure in poorly ventilated spaces.
The disease is preventable and curable.
However, delayed diagnosis can allow it to spread to others and increase the likelihood of severe illness.
The Department’s preparatory work does not mean that M72/AS01E has already passed its clinical trial or that its introduction is guaranteed. Instead, government is developing the plans and systems that would be required if the Phase 3 findings support its approval.
The National TB Recovery Plan includes developing an implementation roadmap, participating in vaccine evidence reviews and preparing for questions involving financing and public access.
Government has also welcomed an agreement between the Gates Medical Research Institute and the Serum Institute of India concerning the future manufacture and global supply of M72/AS01E, subject to successful trial results and regulatory approval.
The Department said the agreement allows for production by pharmaceutical partners in South Africa and Indonesia to increase progressively over time.
According to the World Health Organisation, modelling suggests that a vaccine which is 50% effective at preventing TB disease in adolescents and adults could avert as many as 76 million cases and 8.5 million deaths globally over 25 years if approved and rapidly introduced.
Those projections describe what a vaccine with that level of effectiveness could potentially achieve. They are not a forecast of the final M72/AS01E trial results.
In the meantime, existing TB prevention, testing and treatment services remain essential. The prospect of a future vaccine does not replace the need to investigate possible symptoms such as a persistent cough, unexplained weight loss, fever and night sweats.
The outcome of the Phase 3 trial will determine what happens next.
Only after sufficient evidence has been collected can regulators decide whether M72/AS01E should be approved and which sections of the population should receive it.
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Until then, the country is preparing for the possibility of introducing the first major new TB vaccine in more than a century, while awaiting the scientific evidence required to determine whether that possibility becomes a reality.
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