BCG Vaccines 2023

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Last reviewed
January 21, 2023
Content Overview
BCG is an approved vaccine that prevents diseases such as tuberculosis and bladder cancer. Access to BCG vaccine is limited in the U.S.

BCG Vaccines 2023

Bacille Calmette-Guerin (BCG) vaccines were approved about 100 years ago and are used worldwide. About 14 sub-strains of BCG have evolved and are used in BCG vaccines in 2023. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved BCG vaccines. The U.S. National Institutes of Health (NIH) says the BCG vaccine is safe and not associated with severe complications. 

And the World Health Organization (WHO) has Listed various vaccine versions. In addition, the WHO Expert Committee on Biological Standardization considers the formulation of international requirements for manufacturing and controlling BCG vaccines. In the U.S., BCG vaccination should be considered for select persons who meet specific criteria and consult with a TB expert, says the U.S. Centers for Disease Control and Prevention (CDC). 

BCG Vaccines Approved

In the U.S., Merck's TICE® BCG vaccine is U.S. FDA-approved (STN: 102821). The TICE® strain used in this BCG VACCINE preparation was developed at the University of Illinois from a strain originated at the Pasteur Institute. And in 2018, the U.S. FDA issued Organon Teknika Corp., LLC approval for BCG Live, STN: 103050.

The Serum Institute of India (SII) recombinant BCG (rBCG) vaccine TUBERVAC-rBCG is a single-dose vaccine approved for the prevention of Tuberculosis (TB) in 2023.

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

Verity Pharmaceuticals Inc. announced on September 9, 2021, that it begin distributing VERITY-BCG™ (Bacillus Calmette-Guérin [BCG]: Strain Russian BCG-I) in Canada.

BCG Vaccine Candidates

ImmunityBio's IL-15 Superagonist N-803 Plus BCG is a therapy for adults with Non—muscle-invasive Bladder Cancer.

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

BioNTech announced clinical trial plans for its mRNA vaccine candidate for TB on July 26, 2021.

BCG Vaccine Tuberculosis

Tuberculosis (TB) is primarily an airborne communicable disease caused by Mycobacterium TB. The WHO Global T.B. Report 2022 provides a comprehensive and up-to-date assessment of the TB epidemic and progress in its prevention, diagnosis, and treatment at global, regional, and country levels. The WHO recommends neonatal BCG vaccination in countries or settings with a high incidence of TB.

BCG Vaccine Bladder Cancer

BCG vaccination is the most common intravesical immunotherapy for treating early-stage bladder cancer. Scientists led by Fred Hutch Cancer Center vaccine scientist Jim Kublin, MD, MPH, will apply 21st-century laboratory tools beginning December 6, 2022, to analyze how immune systems respond to BCG USP in a phase 1 clinical trial. If the experiment with isoniazid works as anticipated, it will provide rich data that show exactly how this well-established drug works against the BCG strain, M. bovis.

BCG Vaccine News 2023

January 19, 2023 - Large Increase in Tuberculosis Activity in Alaska during 2022.

January 9, 2023 - Bladder Cancer Treatment Innovates in the Right Direction.

October 1, 2022 - The Lancet peer-review journal published: A next-generation BCG vaccine moves forward.

August 9, 2021 - Scientists from the Hackensack Meridian Center for Discovery and Innovation (CDI) were awarded $6.4 million from the National Institutes of Health (NIH) to pursue an innovative new TB vaccine concept. Gengenbacher and his team have identified a novel type of B-cells that contribute to TB infection control using high-parameter flow cytometry available at the CDI.