Introduction
Tuberculosis (TB) continues to be a major global health challenge, with millions of new cases diagnosed each year. The only licensed vaccine, Bacillus Calmette–Guérin (BCG), has been in use for over 100 years. However, its effectiveness in preventing pulmonary TB in adolescents and adults is limited, necessitating the development of more effective vaccines. This review examines the current TB vaccine landscape and highlights leading candidates which might be available as a new TB vaccine in the near future.
History and burden of Tuberculosis
Tuberculosis is an infectious disease caused by a bacterium called Mycobacterium tuberculosis, which has affected humans for millions of years. Robert Koch discovered the TB bacterium in 1882 and earned a Nobel Prize. However, over 1 billion people have died from TB since then, which is more than the mortality from many other infectious diseases 1. In 2024, about 10.7 million people developed TB, and 1.23 million died globally with South East Asia region having the largest number of new cases 2. Myanmar remains among the 30 countries with highest TB prevalence, with an increase incidence rate of 23% and increased total number of death cases of 4.5% between 2015 and 2024 3,4.
History of BCG vaccine
The BCG vaccine, which is currently used for tuberculosis (TB) prevention, was first developed in 1921 by Albert Calmette and Jean-Marie Camille-Guérin, based on bovine strain of Mycobacterium tuberculosis. Even today, BCG remains the only available vaccine for TB and millions of infants receive it every year soon after birth. It became a core component of the Expanded Programme of Immunization (EPI) launched by World Health Organization in 1974 and is widely administered in more than 150 countries recently. In Myanmar, countrywide BCG immunization was first introduced in 1978 as the country’s EPI was launched.
Limitations of the existing BCG vaccine
Although BCG can prevent severe forms of TB such as meningitis and military TB in infants and children, It does not provide effective protection against infectious pulmonary TB in adolescence and adulthood, the age groups which have the highest rates of TB infection and are also the most likely to transmit the disease to others 5. Adverse reactions of BCG like lymphadenitis, localized abscess and rare disseminated TB are important consequences in some patients, especially in those with HIV infection who cannot be vaccinated with BCG 5.
Urgent need for new TB vaccine
Because of the burden of the disease and limitations of the existing BCG vaccine, there is an urgent need for a new TB vaccine. Additionally, the reduction of support from USAID may increase the risk of TB resurgence and drug-resistant TB globally. Combined with the impact of the COVID-19 pandemic, this could reverse decades of progress in TB control. 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. Since 1990, scientists around the world have been working to develop a new TB vaccine that could potentially eliminate the disease. Nowadays, it seems that their efforts may finally bear fruit 1.
Clinical trials and upcoming new TB vaccines
A. diversity in TB vaccine candidates
Several clinical trials for vaccine candidates are currently conducted as the TB vaccine development pipeline has expanded significantly in recent years. Among them, around six new vaccine candidates are now in the final stages of clinical trials. The current candidates in the clinical pipeline shows diversity of the platform indicating advancement in vaccine technology.
(1) Protein subunit vaccines with potent adjuvants: M72/AS01E, H107e/CAF10b, ID93/GLA-SE, AEC/BC02, and GamTBvac;
(2) Viral-vectored approaches: MVA85A, ChAdOx1.85A (ChAdOx1–MVA85A), AdAg85A, and TB/FLU-05E;
(3) Whole-cell inactivated or fragmented mycobacteria based: DAR-901, RUTI® and Immuvac (MIP);
(4) Live mycobacterial candidates: BCG pre-travel vaccination;
(5) Recombinant BCG based: VPM1002;
(6) Attenuated M. tuberculosis based: MTBVAC;
(7) mRNA-based candidates: BNT164a1 and BNT164b2
(8)Aerosol/Inhaled vaccines targeting lung immunity 6
B. Completed clinical trials with disappointing results
Several such studies have been completed in recent years. However, results have been disappointing:
(1)DAR-901 trial did not show effectiveness
(2)BCG revaccination trial showed conflicting results: one suggested benefit, while a larger follow-up study did not.
(3)H56:IC31 did not show protection from recurrence of TB, and may have even increased relapse risk 2
C. Promising new TB vaccine candidates
(1). M72/AS01E is the most advanced candidate. It is a protein subunit vaccine, being developed by the Gates Medical Research Institute and GlaxoSmithKline. M72 showed nearly 50% effectiveness in preventing TB disease during phase 2 trial, in people who were already infected. This is an important milestone because no previous vaccine has reached this level of protection. A large phase 3 trial has now completed enrolling about 20,000 participants, with results expected in 2028. If phase 3 trials confirm efficacy and safety, regulatory approval could follow within a few years and this vaccine candidate could be the first new TB vaccine after BCG.
(2). MTBVAC is another promising candidate. It is a live-attenuated vaccine based on human strain of Mycobacterium tuberculosis, being developed by Biofabri in collaboration with the University of Zaragoza and supported by the International AIDS Vaccine Initiative. MTBVAC is currently being tested in a phase 2b trial involving adults and adolescents across multiple countries, as well as in a phase 3 trial in newborns.
(3) VPM1002 and Immuvac: Recent results published in April 2026 from a large-scale trial in India provided a mixed but hopeful outlook. Although neither vaccine showed general protection against TB or prevented latent TB infection, both demonstrated prevention against the progression to active TB in people with latent TB. VPM1002 showed significant effectiveness (50.4%) against extrapulmonary TB, both in children and older adults and this is a critical finding, as extrapulmonary TB often carries a higher mortality risk. In children, VPM1002 provided protection against both Pulmonary and Extrapulmonary TB in 6 -14 year age group, while Immuvac provided protection against Extrapulmonary TB only in 6-10 year age group 7.
(4). GamTBvac is a protein adjuvant vaccine, undergoing Phase III trials.
(5). BNT164a1 and BNT164b2 are mRNA vaccines which use the same approach that proved effective in COVID-19 vaccines, being developed by BioNTech. These vaccines are currently being studied in an early phase 2a trial in South Africa 2,6.
Are we close to the goal and how soon?
The World TB Day theme for 2026, “Yes! We can End TB! Led by Countries, Powered by People”, gives a message of hope to end the world’s deadliest infectious disease and It can be achievable soon. If the current phase III trials for M72/AS01E and MTBVAC maintain their schedules without safety interruptions, the first regulatory process can be seen as early as 2027 or 2028.
What are the challenges?
The TB Vaccine Accelerator Council established in 2023 by the World Health Organization (WHO) estimates that global procurement will cost between $5 billion and $8 billion through 2040 8. Regulatory alignment is important to ensure that the vaccines approved in one region should be quickly adopted in high-burden countries. New TB vaccines could be available soon under decisive leadership of the countries, increase global investment and strong multisectoral collaboration 9.
Conclusion
The development of a new tuberculosis vaccine is closer than at any point in the past century. While BCG remains the only licensed vaccine, some vaccine candidates such as M72/AS01E are advancing through late stage clinical trials. Although there are uncertainties, current conditions strongly suggest that new TB vaccines, which are more effective and adult focused, could become available at the end of this decade, marking a major breakthrough in global health.
References
- Are new TB vaccines finally within reach? – VaccinesToday. https://www.vaccinestoday.eu/stories/are-new-tb-vaccines-finally-within-reach/.
- Van Riet, E. et al. Accelerating research and development of new vaccines against tuberculosis: 5-year progress on the global roadmap. Lancet Infect. Dis. S1473309926000198 (2026) doi:10.1016/S1473-3099(26)00019-8.
- Myanmar marks World TB Day 2026; Dy Minister outlines fight against high TB rates | Ministry Of Information. http://www.moi.gov.mm/moi:eng/index.php/news/20574.
- Tuberculosis profile: Myanmar. https://worldhealthorg.shinyapps.io/tb_profiles/_w_66b3daa9841b4f559aec2be50f315059/?_inputs_&tab=%22tables%22&lan=%22EN%22&iso3=%22MMR%22&entity_type=%22country%22.
- Ari, M. M., Beig, M., Sholeh, M. & Khoshmirsafa, M. The BCG vaccine, advantages, and disadvantages of introducing new generation vaccines against Mycobacterium tuberculosis. Clin. Exp. Vaccine Res. 13, 184 (2024).
- Martín, C., Gonzalo-Asensio, J., Aguiló, N. & Arbués, A. Toward tuberculosis elimination: An update on tuberculosis vaccines in clinical trials. Int. J. Infect. Dis. 0, (2026).
- Two new TB vaccines show safety but limited protection. https://www.news-medical.net/news/20260409/Two-new-TB-vaccines-show-safety-but-limited-protection.aspx.
- New WHO report urges bold steps for equitable access to novel TB vaccines. https://www.who.int/news/item/06-11-2025-new-who-report-urges-bold-steps-for-equitable-access-to-novel-tb-vaccines.
- World TB Day 2026 – Yes! We can End TB! Led by countries. Powered by people. https://www.who.int/campaigns/world-tb-day/2026.
Author Information
Win Lai May1, Saw Win2
- MBBS, MMedSc (Paediatrics), PhD(Clinical Tropical Medicine), DipRMRE, Department of Medical Research
- Consultant Paediatrician, Parami General Hospital
