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Content current as of October 12, 2026. AI-assisted draft; not yet reviewed by a licensed pharmacist. Current CDC schedules: immunization schedules.
- The disease and why it matters
- Video and figures
- Get CE credit
- Products available
- Who should get it
- Dosing and schedule, including catch-up
- Administration
- Storage and handling
- Contraindications and precautions
- Safety and adverse events
- Special populations
- Counseling pearls for the pharmacy counter
- Common patient questions
- References
The disease and why it matters
BCG is a vaccine for tuberculosis (TB) disease; it is given to infants and small children in countries where TB is common and protects children from severe forms of active TB disease such as TB meningitis and miliary TB disease, and its protection weakens over time. [1] [2]
The vaccine is not generally used in the United States because of the low risk of TB infection in the United States, the variable effectiveness of the vaccine against adult pulmonary TB, and its potential to cause a false-positive TB skin test reaction. [1]
Video and figures
Video
Get CE credit
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Products available
FDA lists BCG Vaccine (TICE strain; Organon Teknika Corp., LLC), an attenuated, live culture preparation of the bacillus of Calmette and Guérin, for percutaneous use; the label states that it is not a vaccine for the treatment of active tuberculosis, and the FDA page is marked content current as of 12/16/2025. [3] [4]
BCG VACCINE is supplied as one vial of lyophilized (freeze-dried) powder containing 1 to 8 x 10^8 CFU (approximately 50 mg wet weight), and the multiple puncture devices are obtained separately from the manufacturer. [4]
Who should get it
CDC (BCG vaccine page, January 31, 2025)
As of January 31, 2025
In the United States BCG is only considered for people who meet specific criteria and in consultation with a TB expert. For children, vaccination should only be considered for children who have a negative TB test and who are continually exposed, and cannot be separated from adults who are untreated or ineffectively treated for TB disease (with the child unable to be given long-term primary preventive treatment) or who have isoniazid- and rifampin-resistant strains of TB disease. Vaccination of health care workers should be considered on an individual basis in settings in which a high percentage of TB patients are infected with isoniazid- and rifampin-resistant strains, there is ongoing transmission of drug-resistant strains to health care workers with infection likely, or comprehensive TB infection control precautions have been implemented but have not been successful. [1]
FDA label (BCG VACCINE; older-format label, no revision date)
As of December 16, 2025
The label states that ACIP and the Advisory Committee for the Elimination of Tuberculosis recommended that BCG vaccination be considered in these circumstances: infants and children with negative tuberculin skin tests who are at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary TB and who cannot be removed from the source of exposure or placed on long-term primary preventive therapy, or who are continuously exposed to persons with infectious pulmonary TB with bacilli resistant to isoniazid and rifampin and cannot be separated from the infectious patient. For health care workers the label lists three conditions joined by "and" (a high percentage of TB patients infected with isoniazid- and rifampin-resistant strains, likely transmission and infection, and unsuccessful comprehensive infection control), whereas CDC's page (2025) lists them joined by "or". The label states vaccination should not be required for employment or for assignment of health care workers in specific work areas. [4]
Health care workers considered for BCG vaccination should be counseled about the risks and benefits of both BCG vaccination and treatment of latent TB infection. [1]
Dosing and schedule, including catch-up
BCG vaccination is reserved for persons with a reaction of less than 5 mm induration after skin testing with 5 TU of PPD tuberculin; the preferred method is Mantoux using 0.1 mL of 5 tuberculin units, and a Mantoux test is recommended before BCG vaccination to demonstrate absence of tuberculous infection; it should not be given to individuals previously infected with M. tuberculosis. [4]
The immunizing dose is 0.2 to 0.3 mL dropped onto the cleansed deltoid skin and spread over a 1 by 2 inch area with the edge of the multiple puncture device (36 points); the device is pressed firmly for 5 seconds, then the vaccine is spread over the puncture area and 1 to 2 additional drops may be added for a very wet site; in infants less than 1 month old the dosage should be reduced by one-half. [4]
Administration
- Administer only by the percutaneous route with the multiple puncture device; do not inject intravenously, subcutaneously, intramuscularly or intradermally. [4]
- Prepare the suspension using aseptic technique in a separate area, since parenteral drugs should not be prepared in areas where BCG has been prepared; the person mixing should wear gloves and avoid contact with broken skin, and use a mask and gown if preparation cannot be performed in a biocontainment hood; add 1 mL of Sterile Water for Injection at 4 to 25 °C to the vial, swirl gently and avoid forceful agitation; do not filter. [4]
- Keep reconstituted vaccine refrigerated, protected from direct sunlight, and use within 2 hours; freezing of the reconstituted product is not recommended; bacteriostatic solutions must be avoided. [4]
- Loosely cover the site and keep it dry for 24 hours; advise the patient that the vaccine contains live organisms and, although it will not survive in a dry state for long, infection of others is possible; a separate sterile multiple puncture device must be used for each patient; all equipment in contact with the vaccine is handled and disposed of as biohazardous. [4]
- Because BCG is a live vaccine, the immune response might be impaired if given within 30 days of another live vaccine; whenever possible, live vaccines administered on different days should be given at least 30 days apart. [4]
Storage and handling
- Store intact vials refrigerated at 2 to 8 °C (36 to 46 °F); the agent contains live bacteria and should be protected from direct sunlight; do not use after the expiration date. [4]
Contraindications and precautions
| Source | Statement |
|---|---|
| CDC | Immunosuppressed persons (for example HIV) or those likely to become immunocompromised (for example organ transplant candidates) should not receive BCG vaccination; pregnant women should not receive BCG vaccination even though no harmful effects on the fetus have been observed. [1] |
| FDA label | Not for persons whose immunologic responses are impaired by HIV infection, congenital immunodeficiency (for example chronic granulomatous disease or interferon gamma receptor deficiency), leukemia, lymphoma or generalized malignancy, or suppressed by steroids, alkylating agents, antimetabolites or radiation; allergy to any component or an anaphylactic or allergic reaction to a previous dose is a contraindication; not for use in severe immune deficiency syndromes; children with a family history of immune deficiency disease should not be vaccinated. [4] |
| FDA label precaution | BCG should be administered with caution to persons in groups at high risk for HIV infection; vaccination is recommended only for those who are tuberculin negative to a recent skin test with 5 TU. [4] |
Safety and adverse events
Although BCG vaccination often results in local adverse effects, serious or long-term complications are rare; expected reactions include moderate axillary or cervical lymphadenopathy and induration with subsequent pustule formation at the injection site, which can persist for as long as 3 months; more severe local reactions include ulceration, regional suppurative lymphadenitis with draining sinuses, and caseous lesions or purulent drainage, which might occur within 5 months and persist for several weeks. [4]
Systemic effects of 1 to 2 days such as fever, anorexia, myalgia and neuralgia often reflect hypersensitivity, but fever of 103 °F or greater or acute localized inflammation persisting longer than 2 to 3 days suggests active infection and evaluation for serious infectious complication should be considered; if BCG infection is suspected, the physician should consult an infectious disease expert before therapy. [4]
BCG vaccine may cause a false-positive TB skin test reaction and there is no reliable way to distinguish it from a reaction caused by true TB infection; TB blood tests (interferon-gamma release assays) are the preferred test for people who have received BCG, including children, and BCG vaccination does not induce positive results with TB blood tests; multiple BCG doses increase sensitivity and duration of positive skin test results; tuberculin reactivity is likely during the first two years after BCG administration to a newborn. [1]
Special populations
Pregnancy and nursing: the label lists Pregnancy Category C, animal reproduction studies have not been conducted, and although no harmful effects to the fetus have been associated with BCG its use is not recommended during pregnancy; it is not known whether BCG is excreted in human milk, and because of the potential for serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or not to vaccinate. [4]
Older adults and immune status: clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently, and an intact immune system is a prerequisite for BCG vaccination, so vaccination should be held if the immune status of any patient is in question. [4]
Counseling pearls for the pharmacy counter
- Tell the health care provider if you have received the TB vaccine, especially if you are being tested for TB infection, because it can cause a false-positive TB skin test reaction. [2]
- People who have been vaccinated with BCG and have a positive skin test should always be further evaluated for latent TB infection or TB disease as if they were not vaccinated; reactions should be interpreted based on risk stratification regardless of BCG vaccination history. [1]
- Vaccination is given only after the risks and benefits are explained to the vaccinee, parent or guardian, and tuberculin reactivity resulting from BCG should be documented. [4]
Common patient questions
A foreign-born patient had BCG as an infant and has a positive TB skin test. Is it TB?
CDC says there is no reliable way to distinguish a positive skin test reaction caused by BCG from true TB infection; TB blood tests (IGRA) are preferred, and people with prior BCG should be evaluated as if they were not vaccinated. [1]
Should a U.S. nurse working with TB patients receive BCG?
Not routinely: BCG vaccination of health care workers should be considered on an individual basis only in settings with a high percentage of drug-resistant TB, ongoing transmission of drug-resistant strains, or unsuccessful infection control; it is not recommended in low-risk settings. [1] [4]
Can BCG be given to a patient with HIV?
No. Immunosuppressed persons (for example with HIV) should not receive BCG vaccination, and the label contraindicates it in HIV-infected or immunocompromised infants, children or adults. [1] [4]
What skin test result is required before BCG?
BCG vaccination is reserved for persons with a reaction of less than 5 mm induration after a Mantoux skin test with 5 TU of PPD tuberculin. [4]
How long is reconstituted vaccine usable?
Reconstituted vaccine should be kept refrigerated, protected from direct sunlight, and used within 2 hours. [4]
References
- Centers for Disease Control and Prevention. Bacille Calmette-Guérin (BCG) vaccine for tuberculosis (health care providers). Page dated January 31, 2025. Accessed October 12, 2026. https://www.cdc.gov/tb/hcp/vaccines/index.html. Accessed October 12, 2026.
- Centers for Disease Control and Prevention. Tuberculosis vaccine. Page dated June 14, 2024. Accessed October 12, 2026. https://www.cdc.gov/tb/vaccines/index.html. Accessed October 12, 2026.
- U.S. Food and Drug Administration. BCG Vaccine product page (content current as of 12/16/2025). Accessed October 12, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/bcg-vaccine. Accessed October 12, 2026.
- BCG VACCINE (TICE strain), for percutaneous use: package insert as posted on FDA's product page (older-format label; no revision date in the posted document). Organon Teknika Corp. U.S. Food and Drug Administration. Accessed October 12, 2026. https://www.fda.gov/media/78331/download?attachment. Accessed October 12, 2026.
For professional education. Check current labeling and guidance before acting. Not medical advice.
