Despite the progress made, tuberculosis (TB) continues to claim thousands of lives annually in South Africa, but hope is emerging with the development of a new vaccine.
According to data from Gavi, the Vaccine Alliance, a new vaccine with a projected 50% efficacy could prevent up to 7.3 million deaths worldwide. The first versions of these vaccines are expected to receive regulatory approval and licensing between 2029 and 2030.
This vaccine is specifically designed for adults and adolescents, which helps fill a critical protection gap left by the old BCG vaccine, which is over a century old.
The M72/AS01E vaccine, developed by the Gates Medical Research Institute, demonstrated 50% efficacy in Phase 2b trials, with Phase 3 results expected in mid-2028. The African continent will also receive priority status for new TB vaccines under Gavi's African Vaccine Manufacturing Accelerator (AVMA) to stimulate production on the continent.
Why are new TB vaccines urgently needed?
Tuberculosis remains the deadliest infectious disease globally, causing staggering 10.7 million cases and 1.2 million deaths in 2024, with 77% of deaths occurring in Gavi-supported countries. The only existing vaccine, Bacillus Calmette-Guérin (BCG), was used in approximately 250 million doses in 2023.
Although BCG provides up to 90% protection against severe childhood TB, its protective properties weaken over time, and it offers limited protection in adolescents and adults. Since adolescents and adults are the main carriers of ongoing community transmission, World Health Organization (WHO) product standards prioritize vaccines designed to prevent pulmonary TB in these populations.
What will be the impact on healthcare?
Estimates from the London School of Hygiene & Tropical Medicine (LSHTM) suggest that TB vaccines for adolescents and adults will become among the most significant interventions in global health history. Under a high-demand scenario targeting high-prevalence regions and high-risk groups, a 50% effective vaccine could prevent between 5.8 and 20.8 deaths per 1,000 fully vaccinated individuals, equivalent to saving up to 7.3 million lives by 2050. Furthermore, the vaccine will play a vital role in slowing the spread of drug-resistant TB strains.
Leading candidates
Currently, seven candidate vaccines are undergoing Phase 1, 2, and 3 clinical trials aimed at preventing the disease in adults and adolescents using adjuvant protein, live attenuated, and mRNA platforms. M72/AS01E (Gates Medical Research Institute) is an adjuvant protein-based candidate, showing 50% efficacy in Phase 2b trials and an acceptable safety profile for people living with HIV in Phase 2a trials. Phase 3 results are expected in mid-2028, with potential licensing by 2029–2030.
GamTBvac (Gamaleya Federal Research Centre) is an adjuvant protein-based candidate undergoing Phase 3 trials to assess efficacy against non-HIV respiratory TB; trial completion is expected in 2026.
Delivery strategy and demand scale
Global health partners recommend a dual approach to implementation. This includes routine immunization, where vaccinating adolescents builds long-term population immunity, as well as targeted catch-up campaigns initially focused on high-risk groups (such as people living with HIV) and high-burden geographic areas.
Demand is projected to average 86 million doses annually in low- and middle-income countries, with the peak demand occurring in the early years when high-incidence countries begin catch-up campaigns. Procuring doses to meet global demand between 2030 and 2040 will require funding of $5–8 billion.
Production in Africa and Gavi's Global Roadmap
The central goal of Gavi's market shaping strategy is to create a geographically diverse supply chain to prevent initial supply bottlenecks. New TB vaccines have received priority status under the African Vaccine Manufacturing Accelerator (AVMA).
Gavi is expected to utilize AVMA financial incentives and is also exploring potential future adjustments to encourage vaccine production in Africa, thereby diversifying the future supply base and strengthening regional access. Strategic plans aim to develop a competitive portfolio of candidates that align with country preferences regarding dosing schedules, storage requirements, and accessibility.
Gavi is also coordinating with the Global Fund and working with the WHO Working Group on Accelerating Access and Financing for TB Vaccines to prepare high-burden countries for rapid deployment.
Statistics
Recent estimates from the World Health Organization (WHO) show that approximately 249,000 people contracted TB in South Africa in 2024, and about 54,000 died from the disease. It should be noted that these figures are approximate, as not every TB case is diagnosed and registered.
TB incidence in the country has significantly decreased over the last decade. In 2023, WHO estimated the incidence in South Africa at 427 cases per 100,000 people, compared to 988 cases per 100,000 people in 2015. The annual WHO report on South Africa described this as a 57% reduction compared to the 2015 baseline.
Thousands of cases remain undetected
Despite improvements in identifying and treating people with TB, a significant gap remains between the number of people estimated to have TB and those who have been diagnosed. WHO previously estimated that the number of 'missed' TB cases in South Africa decreased from approximately 150,000 in 2019 to 66,000 in 2022—a 56% reduction.
The National TB Control Plan states that treatment coverage increased to 79% in 2023, although concerns persist regarding undiagnosed or untreated individuals.
TB and HIV remain closely linked
HIV remains a major factor in the TB epidemic in South Africa. WHO reports that people living with HIV are 12 times more likely to contract TB than people without HIV. TB is also one of the leading causes of death among people living with HIV.
Even more alarming is that, according to the WHO Global TB Report for 2025, children aged 0 to 14 accounted for about 7% of the TB burden in the country. This is below the expected share of 10–15% in high-burden countries. South Africa is also among the countries with a high burden of multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB).
The latest WHO report indicates that South Africa was among the countries with the largest global gaps between the estimated number of people infected with MDR/RR-TB and those who started treatment in 2024. South Africa accounted for about 3% of this global gap. Nevertheless, the country became one of the first to implement shorter oral treatment regimens for drug-resistant TB.
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