New Tuberculosis Vaccines: Where Research Stands
For the first time in many decades, the world is closer to the development of new tuberculosis vaccines. The most advanced of these, M72/AS01E, is currently in Phase 3 clinical trials. At the same time, scientists are evaluating the live-attenuated vaccine MTBVAC, improved versions of BCG, as well as protein, vector, and mRNA vaccine candidates.
However, it is important to understand this progress correctly. Currently, BCG remains the only widely used vaccine against TB. None of the new candidates has yet received all the necessary regulatory approvals for widespread use.
Why the World Needs New Vaccines
BCG has been in use since 1921 and remains a vital tool for protecting children against severe forms of tuberculosis. At the same time, it provides limited protection for adolescents and adults against pulmonary TB, which is the most common form of the disease and the primary source of transmission.
According to data from the Gates Medical Research Institute, in 2024, approximately 10.7 million people contracted TB, and 1.25 million died. Therefore, a vaccine capable of protecting adolescents and adults against pulmonary TB could have a significant impact on the spread of the infection.
M72/AS01E: The Most Advanced Candidate
M72/AS01E is a protein subunit vaccine. It consists of the M72 antigen, which helps the immune system recognize Mycobacterium tuberculosis, and the AS01E adjuvant, which enhances and broadens the immune response.
The vaccine was originally developed by GSK. Its further clinical development is now led by the Gates Medical Research Institute with financial support from the Gates Foundation and Wellcome.
In a Phase 2b trial involving 3,575 participants, M72/AS01E demonstrated approximately 50% protection against progression to active pulmonary TB over three years among HIV-negative adults infected with Mycobacterium tuberculosis.
This result represents an important scientific breakthrough, but it is not sufficient for vaccine approval. Efficacy and safety must be confirmed in a much larger and more diverse trial.
What’s Happening in Phase 3
Phase 3 of the M72/AS01E trial began in March 2024. In April 2025, recruitment of 20,000 participants across 54 study sites in South Africa, Kenya, Malawi, Zambia, and Indonesia was completed.
Participants aged 15–44 received either the vaccine candidate or a placebo. The trial is double-blind: neither the participants nor the researchers know who received M72/AS01E. Participants will be followed for up to four years to assess the vaccine’s safety and its ability to prevent the development of pulmonary TB.
The study includes people with and without TB infection, as well as a separate group of people living with HIV. This is important because the future vaccine must be safe and effective for different population groups.
Production preparations are underway
In July 2026, the Gates Medical Research Institute and the Serum Institute of India announced an agreement to prepare for the production of M72/AS01E.
The Serum Institute of India plans to invest more than $100 million in production readiness and capacity expansion. GSK will supply the AS01E adjuvant. The partners also plan to involve local manufacturers in Indonesia and South Africa in specific parts of the future supply chain.
These preparations will help reduce the time between potential vaccine approval and the start of its distribution. However, the manufacturing agreement does not guarantee positive trial results and does not replace regulatory review.
MTBVAC: Another Promising Approach
MTBVAC is a live-attenuated vaccine based on the human tuberculosis pathogen. To reduce its virulence, researchers removed two genes associated with the bacterium’s ability to cause disease.
This fundamentally distinguishes MTBVAC from BCG, which is based on Mycobacterium bovis. The developers hypothesize that a broader range of antigens may elicit a stronger immune response, but this hypothesis must be definitively tested in clinical trials.
MTBVAC is being studied as a potential vaccine for newborns, as well as for adolescents and adults. It is among the most promising candidates after M72/AS01E, but is at an earlier stage of efficacy evaluation.
The Next Generation: mRNA and Other Platforms
The portfolio of TB vaccines is not limited to these two candidates. Protein subunit, live-attenuated, viral vector, and mRNA vaccines are currently in clinical trials.
In particular, BioNTech is developing the mRNA candidates BNT164a1 and BNT164b1 with support from the Gates Foundation. They are in the early stages of clinical development, so there is currently no data on their ability to prevent the disease.
Research into different technologies increases the chances of finding vaccines for various population groups. One vaccine may be optimal for newborns, another for adolescents and adults, and a third for people who are already infected with Mycobacterium tuberculosis.
What This Means for Communities
Vaccine development should not proceed without the involvement of people and communities affected by TB. They must be involved in planning research, developing accessible information, determining an affordable price, and establishing equitable distribution mechanisms.
Early production planning is a positive sign, but accessibility will be determined by more than just the number of doses produced. Price, World Health Organization recommendations, national vaccination programs, the readiness of health care systems, and public trust will all play a role.
What’s important to remember
M72/AS01E, MTBVAC, and mRNA candidates are not yet available vaccines for mass use. They are undergoing clinical trials designed to confirm their safety and efficacy.
At the same time, current progress gives cause for cautious optimism. If the Phase 3 trial of M72/AS01E is successful, the world could gain its first new TB vaccine in over a century—and the first specifically designed to protect adolescents and adults.
A vaccine alone will not be enough to defeat tuberculosis. It must reinforce—not replace—early diagnosis, accessible treatment, prevention, social support, and the fight against stigma.
TB People will continue to monitor the results of clinical trials and explain what new scientific developments mean for people and communities affected by TB.