BCG Vaccines 2023

Authored by
Last reviewed
May 10, 2023
Content Overview
BCG vaccine is a FDA approved to prevent tuberculosis and bladder cancer in May 2023. Access to BCG vaccine is limited in the U.S.

BCG Vaccines May 2023

Bacille Calmette-Guerin (BCG) vaccines were approved about 100 years ago and are used worldwide today. About 14 sub-strains of BCG have evolved and were used in vaccines in May 2023 to protect people from Mycobacterium tuberculosis (Mtb), the bacterium that causes tuberculosis (TB). The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved BCG vaccines. Additionally, the U.S. National Institutes of Health (NIH) says BCG vaccination is safe, effective, and not associated with severe complications. 

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

BCG Vaccine Shortage

The End Drug Shortages Alliance and two of its members conducted a survey in February 2023 to better characterize the implications of the BCG shortages. About 20% of the organizations reported not being able to provide full BCG vaccinations to eligible cancer patients.

BCG Vaccinations Africa

BCG vaccines are used within national vaccination programs of African countries. A January 2023 report from Welcome gathers the perspectives of vaccine manufacturers in Africa, highlighting the challenges to scaling up vaccine manufacturing capacity and capabilities and the areas where manufacturers most need support.

BCG Vaccines Approved 2023

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.

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.

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. VERITY-BCG™ Strain Russian BCG-I) in Canada.

France BCG vaccine program (Pasteur 1173P2).

Brazil strain (BCG Mearou RJ)

Bulgarian substrain (Sofia SL222)

Japan 172 strain (Tokyo 172-1)

BCG-Denmark (Statens Serum Institute)

BCG Vaccine Candidates 2023

Access to Advanced Health Institute published results of a Phase 1 clinical trial 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.

ImmunityBio's IL-15 Superagonist (Anktiva™) 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 News 2023

May 2, 2023 - The US Preventive Services Task Force published updated guidelines for TB-related testing and treatment.

January 25, 2023 - A new report by Wellcome, Biovac, and BCG details vaccine manufacturers' perspectives on the challenges they face and the areas where they most need support.

January 17, 2023 - The WHO plans to establish a TB Vaccine AcceleraCouncilncil.

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