Tuberculosis BCG Vaccines
Tuberculosis BCG Vaccines December 2025
According to the World Health Organization (WHO) Global Tuberculosis Report, tuberculosis (TB) is a vaccine-preventable disease. Versions of the BCG vaccine have been used for about 100 years. Since 1921, more than 4 billion Bacille Calmette-Guérin (BCG) vaccinations have been administered worldwide. The WHO states that increasing access to BCG vaccines could save up to 1.9 billion antibiotic doses annually, thereby helping to reduce antimicrobial resistance and the disease burden, which is essential for achieving TB elimination. While BCG has demonstrated significant effectiveness (50%), protection against all TB forms in all age groups has not been consistent. As of November 2025, no universal BCG vaccination policy has been established.
On November 6, 2025, the WHO published the TB Vaccine Accelerator Council report, which estimates that global procurement of TB vaccines for all countries could cost US$5 billion to US$8 billion from 2030 to 2040. On November 6, 2025, the WHO published the report, "Catalysing solutions for equitable global access for sustainable financing for novel tuberculosis vaccines for adults and adolescents," which presents a first-of-its-kind analysis of the anticipated barriers, bottlenecks, and market dynamics that could impact timely, equitable, and sustainable access to novel TB vaccines.
The WHO's Product Development for Vaccines Advisory Committee (PDVAC) has recommended the development of a preferred product characteristic (PPC) for new TB vaccines. Several BCG vaccines based on different bacterial strains are available worldwide. The WHO's End TB Strategy outlines the Sustainable Development Goals to End TB by 2030. As of May 2025, the WHO's TB Research Tracker listed vaccine candidates in clinical development, with four in Phase III scheduled to end in 2025. As of 2024, the Bill and Melinda Gates Foundation and Wellcome have pledged $550 million (to the Gates Medical Research Institute) to support late-stage clinical trials for a new tuberculosis vaccine.
As of October 2025, the WHO recommends BCG vaccination at birth in countries where tuberculosis is endemic. In 2023, 323 million doses of BCG were administered worldwide, and the most commonly used strains were those WHO prequalified: Danish 1331, Bulgarian SL-222, Russian I, and Tokyo 172-1. In 2002, BCG vaccination for neonates was practiced in 157 countries and territories.
Tuberculosis BCG Vaccine United States
Merck's TICE® BCG vaccine is approved by the U.S. Food and Drug Administration (FDA) (STN: 103050) and produced by Organon Teknika Corp., LLC for use in the United States. According to the U.S. Centers for Disease Control and Prevention (CDC), BCG vaccination is considered for people who meet specific criteria, such as children with a negative TB test who are continually exposed and cannot be separated from adults who are untreated or ineffectively treated for TB.
As of March 13, 2025, the Serum Institute of India and ImmunityBio's recombinant Bacillus Calmette-Guérin (rBCG) (TUBERVAC-rBCG) vaccine became available in the U.S. for bladder cancer therapies. The rBCG vaccine has two gene modifications to improve its immunogenicity and safety. It has demonstrated potent immunogenicity, stimulating both CD8+ and CD4+ T cells, and improved safety compared to earlier BCG strains and formulations. Anova Enterprises, Inc. is helping manage ImmunityBio's rBCG Expanded Access Program.
Tuberculosis BCG Vaccines Global
Blessina Kumar, a member of WHO's Civil Society Taskforce on TB, confirmed 16 TB vaccines were available in countries such as the U.S., Canada, China, Cuba, Ethiopia, Jamacia, Japan, Germany, UK, Mexico, Europe, Brazil, Korea, Russia, Spain, South Africa, Quebec, India (1948), New Zealand, Australia, Venezuela, and Nigeria. The BCG Atlas is an open-source database of global BCG vaccination policies and practices.
The Serum Institute of India (SII) rBCG vaccine TUBERVAC-rBCG was approved in 2023 as a single-dose vaccine for the prevention of TB. The National TB Elimination Program (NTEP) underscores the Government of India's goal to eliminate TB in the country. In July 2023, the Indian government approved the export of the rBCG vaccine to Canada for use in immunotherapy to treat bladder cancer. On February 19, 2025, the U.S. Food and Drug Administration (FDA) authorized an expanded access program to bring rBCG to patients in the United States. As of April 2025, SII is the world's largest manufacturer of BCG vaccines.
BCG vaccine AJV (A.J. Vaccines) is the only licensed BCG vaccine in the UK as of 2023. Beginning in September 2021, eligible babies born in the UK were offered the BCG vaccine at 28 days or soon after. This PGD is for the administration of BCG Vaccine AJV to individuals up to 16 years of age who are at increased risk of TB.
Verity Pharmaceuticals Inc. VERITY-BCG™ Strain Russian BCG-I) in Canada. VERITY-BCG™ is an adjuvant therapy and is only recommended for stage Ta grade 1 papillary tumors when there is judged to be a high risk (>50%) of tumor recurrence.
France BCG vaccine program (Pasteur 1173P2). In France, BCG vaccination is recommended from 1 month of age for children at high risk of TB and may also be offered up to 15 years, in unvaccinated children at risk.
Brazil strain (BCG oral Mearou RJ). The BCG vaccine, widely used in Brazil for newborns, provides adjuvant protection against several diseases, including childhood viral infections. The genomics, proteomics, and vaccine trials for oral BCG Moreau in Rio de Janeiro are under investigation. A 2023 study found that recombinant BCG generated high levels of immune memory cells for up to six months in animal models. The Brazilian Bolsa Família Program (BFP) reduced TB incidence, mortality, and case-fatality rates.
Bulgarian substrain (Sofia SL222)
Japan 172 strain (Tokyo 172-1)
BCG-Denmark 1331 - Statens Serum Institute BCG-Denmark vaccination had a beneficial effect on herpes. However, another study found that it did not reduce the initial risk of QFT Plus among healthcare workers.
Tuberculosis Vaccine Candidates
Sponsored by the International AIDS Vaccine Initiative, the H56:IC31 TB vaccine candidate contains the fusion proteins Ag85B, ESAT-6, and Rv2660c, along with the IC31 adjuvant. It has been highly anticipated for its potential to reduce tuberculosis recurrence rates. In clinical trials, H56:IC31 has been found safe and capable of eliciting strong T-cell responses and specific IgG antibodies in adults undergoing treatment for drug-sensitive tuberculosis and in HIV-negative healthy adolescents.
MTBVAC is the first live attenuated BCG vaccine of Mycobacterium tuberculosis isolated from a human. In 2024, Bharat Biotech International Limited started a series of clinical trials in collaboration with IAVI and Biofabri. If MTBVAC is shown to be efficacious, Biofabri, IAVI, and other partners will work together to ensure a sufficient and affordable supply is available for low— and middle-income countries.
The M72/AS01E (M72) subunit protein vaccine candidate and GSK's Adjuvant System AS01 are conducting phase 3 clinical research. As of March 2025, a Phase 3 trial is ahead of schedule and has already recruited 90% of the 20,000 people it needs.
The University of Oxford conducted a Phase 1 clinical trial for an aerosol-inhaled live-attenuated Mycobacterium bovis BCG vaccine. On April 12, 2024, the first-in-human aerosol BCG-controlled human infection model was reported to be sufficiently well-tolerated. Further work will evaluate the utility of this model in assessing vaccine efficacy and identifying potential correlates of protection.
Access to Advanced Health Institute published the results of a Phase 1 clinical trial (June 2023) in collaboration with the U.S. NIH. The trial demonstrated the safety and immune responses of a novel vaccine against TB that combines several proteins from M. tuberculosis (Mtb) into a fusion protein (ID93) and a proprietary immune-stimulating adjuvant (GLA-SE) in a freeze-dried formulation.
BioNTech SE announced clinical trial plans for its mRNA vaccine candidate for TB on July 26, 2021. In April 2023, BioNTech initiated a Phase 1 clinical trial of BNT164, an mRNA vaccine candidate against TB, in partnership with the Bill and Melinda Gates Foundation. A Phase Ib trial (NCT05547464) conducted in Africa evaluates three dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule. A Phase Ia trial (NCT05537038) will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) in a three-dose schedule.
SII VPM1002 is a recombinant BCG vaccine derived from the Danish strain of BCG, also known as the Prague subtype. It expresses listeriolysin, which enables the bacilli to access the host cell cytoplasm and, thus, potentially enhance CD8+ T-cell activation. It also induces inflammasome activation.
IDRI's ID93 + GLA-SE TB vaccine candidate was found safe and immunogenic in healthy adults on March 6, 2023. A US NIH-funded randomized clinical trial of single-vial lyophilized ID93 + GLA-SE is ongoing. Christopher B. Fox, Ph.D., and scientists at the Access to Advanced Health Institute developed ID93+GLA-SE. It is a recombinant subunit vaccine composed of four proteins from the Mycobacterium tuberculosis bacterium, combined with GLA-SE, an immune-stimulating adjuvant.
BIOFABRI MTBVAC is a live-attenuated vaccine against TB, concurrently conducting phase clinical research. GamTBvac, developed by the Gamaleya Federal Research Center of Epidemiology and Microbiology, is in Phase 3 development.
Longhorn Vaccines and Diagnostics LLC LHNVD-301 is an unconjugated, peptide-based vaccine that combines an MTB heat shock protein epitope and a peptidoglycan (PGN) epitope. PGN is a bacterial cell wall component that plays an essential role in infections. The combination of heat shock proteins and PGN generates broadly reactive antibodies. It represents a novel approach that combats AM and targets tuberculosis by combining multiple MTB-specific epitopes and common to gram-positive bacteria into a peptide vaccine.
The National Institutes of Health recently awarded the University of Montana a $12.3 million contract to develop a novel adjuvant for TB vaccines. The grant to the University of Montana's Center for Translational Medicine will advance a TB vaccine candidate from pretrial to clinical trials.
CanSinoBio and Etana are conducting clinical research in Indonesia for the AdHu5Ag85A vaccine.
Research published in Nature Microbiology on January 10, 2025, by the University of Pittsburgh suggests that a self-destructing intravenously administered vaccine provides additional protection against tuberculosis in macaque monkeys.
Recombinant BCG Vaccine
Recombinant BCG (rBCG) has demonstrated potent immunogenicity, stimulating both CD8+ and CD4+ cells, and improved safety compared to standard BCG in European clinical trials. rBCG strains expressing immunomodulatory factors have been investigated for 30 years to enhance immunotherapy against bladder cancer and other diseases. Serum Institute of India (SII) confirmed in May 2024 that it was manufacturing next-generation rBCG. Researchers from Brazil's Butantan Institute and their collaborators announced on July 3, 2024, that they are developing an rBCG vaccine that increases the protection rate to 99% and offers more extended protection.
Universal BCG Vaccine
World leaders have committed to licensing at least one new TB vaccine. WHO-commissioned research estimates that, over 25 years, a universal BCG vaccine that is 50% effective in preventing TB could avert up to 8.5 million deaths and reduce health costs by $6.5 billion. Harvard T.H. Chan School of Public Health researchers announced on February 17, 2023, that a recent study found that introducing an effective TB vaccine in low—and middle-income countries could yield billions of dollars in potential health and economic benefits.
Gene-Edited BCG Vaccine Candidate
In April 2024, researchers at the University of the Witwatersrand School of Pathology published a breakthrough study in TB vaccine development. They gene-edited the BCG to make it more effective. A modified BCG that depletes enzymes involved in peptidoglycan amidation provides enhanced protection against tuberculosis in mice. In vitro and in vivo experiments in this study demonstrate the feasibility of gene-regulatory platforms, such as CRISPRi, to tailor antigen presentation in Ber, thereby tuning it towards more effective protection against TB disease.
Tuberculosis Vaccine Vs. TB Treatment Cost
The global average cost for BCG vaccination is about $5.00. A study summarizing evidence from 76 studies published between 2011 and 2024, and released in April 2025, found that the total mean costs per person for TB care ranged from $7.13 to $11,329. TB patients who incur catastrophic costs are 2-4 times more likely to experience treatment failure. A 2023 study estimated that introducing an adolescent/adult vaccine could yield $283 to $474 billion in economic benefits by 2050.
