Tuberculosis Vaccines

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Last reviewed
December 1, 2023
Content Overview
Tuberculosis is a vaccine preventable disease with the BCG vaccine in 2023

Tuberculosis Vaccines 2023

According to the World Health Organization (WHO), tuberculosis (TB) is a vaccine-preventable disease. The WHO's Director-General, Dr. Tedros Adhanom Ghebreyesus, announced plans in 2023 to establish a new TB Vaccine Accelerator Council. The WHO's End TB Strategy outlines the Sustainable Development Goals to End TB by 2030. World leaders committed to reaching 90% of those who need preventive TB treatment and licensing at least one new TB vaccine.

Blessina Kumar, a member of WHO's Civil Society Taskforce on TB and CEO of the Global Coalition of TB Advocates, confirmed about 16 TB vaccines are available in 2023. BCG vaccines are 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 founded in 2011. 

As of December 2023, various BCG vaccine candidates are under development, as about 14 BCG sub-strains have evolved. As of October 2023, the Tuberculosis Vaccines Pipeline Report provides updates on the clinical development of 17 vaccine candidates. The Bill and Melinda Gates Foundation and Wellcome pledged $550 million (Gates Medical Research Institute) to support late-stage clinical trials for a new tuberculosis vaccine. 

Bacille Calmette-Guérin (BCG) has been used for about 100 years with proven safety records. However, no universal BCG vaccination policy exists, and its efficacy remains controversial in 2023. Neonatal BCG vaccination offers partial protection for infants and young children against severe forms of TB but is less efficient in protecting adolescents and adults.

Tuberculosis Vaccine U.S.

Merck's TICE® BCG vaccine is U.S. FDA-approved (STN: 103050) and is produced by Organon Teknika Corp., LLC for use in the USA. The BCG vaccine is considered for people who meet specific criteria in the United States. BCG vaccination is considered for children with a negative TB test and who are continually exposed and cannot be separated from adults who are untreated or ineffectively treated for TB, says the U.S. Centers for Disease Control and Prevention (CDC). 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 lead to billions of dollars in potential health and economic benefits. In addition, a recent WHO-commissioned study estimates that, over 25 years, a vaccine that is 50% effective in preventing TB among adolescents and adults could avert up to 8.5 million deaths and reduce US$ 6.5 billion in costs, especially for the poorest and most vulnerable.

BCG Vaccines Global

The Serum Institute of India's recombinant BCG (rBCG) vaccine TUBERVAC-rBCG was approved in 2023 as a single-dose vaccine for the prevention of TB.

BCG vaccine AJV (A.J. Vaccines) is the only licensed BCG vaccine in the UK in 2023. Beginning in September 2021, eligible babies born in the UK were offered the BCG vaccine at 28 days or soon after. 

Verity Pharmaceuticals Inc. VERITY-BCG™ Strain Russian BCG-I) in Canada.

France BCG vaccine program (Pasteur 1173P2).

Brazil strain (BCG oral Mearou RJ)

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 labialis.

BCG Vaccine Candidates 2023

Access to Advanced Health Institute published results of a Phase 1 clinical trial (June 2023) in collaboration with the U.S. NIH demonstrating the safety and immune responses in a novel vaccine against TB that combines several proteins from Mtb into a fusion protein (ID93) with a proprietary immune-stimulating adjuvant (GLA-SE) in a freeze-dried formulation.

SII VPM1002 is a recombinant BCG vaccine derived from the BCG Danish subtype Prague. VPM1002 expresses listeriolysin to enable the bacilli to access the host cell cytoplasm and thus potentially enhance CD8+ T-cell activation; it also induces inflammasome activation.

BioNTech SE announced clinical trial plans for its mRNA vaccine candidate for TB on July 26, 2021. In April 2023, BioNTech initiated a randomized, controlled, dose-finding Phase 1 clinical trial of BNT164, an mRNA vaccine candidate against TB, in partnership with the Bill and Melinda Gates Foundation.

IDRI's ID93 + GLA-SE TB vaccine candidate was found safe and immunogenic in healthy adults on March 6, 2023. A US NIH-funded phase 1 double-blind, randomized clinical trial of single-vial lyophilized ID93 + GLA-SE is ongoing. ID93+GLA-SE was developed by Christopher B. Fox, Ph.D., and scientists at the Access to Advanced Health Institute and is a recombinant subunit vaccine made from four proteins of Mycobacterium tuberculosis bacteria combined with GLA-SE, an immune-stimulating adjuvant.

MTBVAC is a live attenuated vaccine against TB conducting phase 3 clinical research.

The M72/AS01E (M72) subunit vaccine candidate combined with GSK's Adjuvant System AS01 is conducting phase 3 clinical research.

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 cell wall component of bacteria that plays aan essentialrole in infections. The combination of heat shock protein and PGN generates broad reactive antibodies. It represents a novel approach that combats AMR while targeting tuberculosis by combining multiple epitopes specific to MTB 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. 

Tuberculosis Outbreaks

Tuberculosis outbreak news during 2023 is posted at Precision Vax.

Tuberculosis Tests

As of 2023, the USPSTF recommends screening for latent tuberculosis infection in populations at increased risk.

Tuberculosis Medication

On July 13, 2023, Johnson & Johnson granted Stop TB Partnership's Global Drug Facility licenses that enable Global Drug Facility to tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low- and middle-income countries, including countries where patents remain in effect.