BCG vaccine is a lyophilized preparation of live, attenuated organisms of the Calmette-Guérin strain of Mycobacterium bovis that is used to stimulate active immunity to tuberculosis infection.1
BCG vaccine is used for the prevention of tuberculosis (TB) in individuals not previously infected with M. tuberculosis who are at high risk for exposure.1, 110 The manufacturer states that BCG vaccine is only recommended for individuals who have tested negative to a recent tuberculin skin test with 5 TU.1
BCG vaccine is particularly effective in preventing severe forms of TB disease such as disseminated and meningeal TB in young children, with protective efficacy rates as high as >80%; however, efficacy of the vaccine in preventing pulmonary TB disease in adults and adolescents has been more variable.1, 111, 112 While BCG vaccine is used routinely outside the US, particularly in countries where TB is endemic, use of the vaccine in the US is limited because of the low risk of M. tuberculosis infection in the overall US population, the variable effectiveness of the vaccine against pulmonary TB in adults, and the vaccine's potential to cause a false-positive TB skin test reaction, which can complicate the management of individuals who may be infected with M. tuberculosis .1, 110, 111 Additionally, widespread implementation of TB infection control measures in the US has successfully decreased the number of outbreaks in the healthcare setting and decreased healthcare-associated transmission of M. tuberculosis to patients and healthcare workers.111
The US Centers for Disease Control and Prevention (CDC) provides recommendations for the use of BCG vaccination in the US.110 The most current CDC guidelines recommend the use of BCG vaccine only in selected individuals who meet specific criteria and in consultation with a TB expert.110 CDC states that BCG vaccination should only be considered for children who have a negative TB test who are continuously exposed and cannot be separated from adults who are untreated or ineffectively treated for TB disease and who cannot be given long-term primary preventive treatment for TB infection; or have isoniazid- and rifampin-resistant strains of TB.110 BCG vaccination also should be considered in certain healthcare personnel on an individual basis in settings where the likelihood of transmission and subsequent infection with drug-resistant strains of M. tuberculosis is high and comprehensive TB infection control precautions in the workplace have been unsuccessful.110 Healthcare providers can consult their state or local TB control program for additional information regarding BCG vaccination for patients.110
Dispensing and Administration Precautions
BCG vaccine is administered percutaneously in the deltoid region using a sterile, single-use, multiple-puncture device; the vaccine should not be administered IV, intramuscularly, subcutaneously, or intradermally.1
BCG vaccine for percutaneous administration is commercially available as a lyophilized powder; the powder should be reconstituted prior to administration.1 To prepare an adult dose, reconstitute the vaccine by adding 1 mL of sterile water for injection to one single-dose vial of the vaccine.1 To prepare a pediatric dose, reconstitute the vaccine by adding 2 mL of sterile water for injection to one single-dose vial of the vaccine.1 Gently swirl the vial until a homogenous suspension is obtained; avoid forceful agitation of the vial.1 Do not filter the contents of the vial.1 The reconstituted vaccine should be kept refrigerated (do not freeze), protected from direct sunlight, and used within 2 hours.1 Discard any unused portions.1
To administer the vaccine, prepare and clean the skin.1 Drop the immunizing dose (0.2-0.3 mL) of BCG onto the surface of the skin and spread over a 1 by 2 inch area using the multiple-puncture device.1 An additional 1-2 drops of the vaccine may be added to ensure a very wet vaccination site.1 Loosely cover the site and keep dry for 24 hours after administration.1
Store intact vials of BCG vaccine refrigerated (2-8°C) and protect from direct sunlight.1
Prevention of Tuberculosis (TB)
For the prevention of TB, the usual dosage of BCG vaccine in adults and children 1 month of age or older is 0.2-0.3 mL.1 In neonates younger than 1 month of age, the dosage of BCG vaccine should be decreased by 50% by reconstituting the vaccine with 2 mL instead of 1 mL of sterile water for injection without preservatives; if indications for BCG vaccine persist and the neonate has an insignificant reaction to the tuberculin skin test, a full dose of the vaccine should be given after 1 year of age.1
Tuberculin reactivity resulting from BCG vaccination should be documented.1 A tuberculin skin test should be performed in a vaccinated individual 2-3 months after BCG administration, and the test results (in mm of induration) should be recorded in the medical record.1 Repeat vaccination for those who remain tuberculin negative to 5 TU of tuberculin after 2-3 months.1
BCG vaccine should be administered by the percutaneous route with the multiple-puncture device as described in the manufacturer's prescribing information.1 The vaccine should not be injected IV, subcutaneously, intramuscularly, or intradermally.1 BCG vaccine preparation contains live bacteria; therefore, special precautions including aseptic technique should be used when preparing the vaccine.1 All equipment and supplies used in vaccine preparation should be disposed of properly in biohazardous containers.1 Parenteral drugs should not be prepared in areas where BCG has been handled to avoid cross-contamination.1
Local effects may occur after vaccination with BCG vaccine and include moderate axillary or cervical lymphadenopathy and induration and subsequent pustule formation at the injection site; these reactions can persist for as long as 3 months after vaccination.1 More severe local reactions may occur up to 5 months after vaccination and persist for several weeks including ulceration at the vaccination site, regional suppurative lymphadenitis with draining sinuses, and caseous lesions or purulent drainage at the puncture site.1
The intensity and duration of local reactions depend on the depth of penetration of the multiple-puncture device and individual patient response.1 Slight tenderness at the puncture site may be encountered as well as some itching.1 The initial skin lesions usually appear within 10-14 days and consist of small red papules at the site.1 The papules reach maximum diameter (about 3 mm) after 4 to 6 weeks, after which they may scale and then slowly subside.1
Systemic signs and symptoms consistent with a "flu-like" syndrome (e.g., fever, anorexia, myalgia, neuralgia) have occurred for 24 to 48 hours following administration of BCG vaccine; these effects are generally consistent with hypersensitivity reactions.1 However, a fever (≥103°F) or acute localized inflammation persisting for longer than 2-3 days may be suggestive of active infections.1 If an active infection is suspected, further evaluate the patient and consult with an infectious disease specialist.1 Treatment with antimycobacterial agents should not be delayed while the diagnostic evaluation, including cultures, is being conducted.1 Negative cultures do not necessarily rule out infection.1
Disseminated BCG infection, which can be fatal, has occurred following administration of BCG vaccine; most reported cases have occurred in immunocompromised individuals.1 The most frequent disseminated infection is BCG osteomyelitis.1 Disseminated and/or localized BCG infections have been reported following administration of BCG vaccine to patients with symptomatic HIV infection who are immunosuppressed in association with acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of HIV infection.100, 105, 120 In at least one infant with asymptomatic HIV infection who received BCG vaccine, a possible disseminated BCG infection occurred since the BCG strain of M. bovis was isolated from the lymph node and CSF several months after vaccination.113 Disseminated BCG infections also have been attributed to previous vaccination in several patients who subsequently manifested symptomatic HIV infection.120, 121 If systemic BCG infection occurs, consult an infectious disease expert and initiate appropriate anti-tuberculosis therapy.1
Individuals with Altered Immunocompetence
BCG vaccine is contraindicated in individuals with conditions that can cause immunodeficiency (HIV infection, congenital immunodeficiency, leukemia, lymphomas, generalized malignancy) and those receiving immunosuppressant agents (e.g., steroids, alklyating agents, antimetabolites, radiation therapy).1 BCG vaccine should be administered with caution to individuals at high risk for HIV infection.1
Following administration of BCG vaccine, it is usually impossible to distinguish between tuberculin sensitivity caused by M. tuberculosis infection and tuberculin sensitivity resulting from the vaccine; therefore, caution should be exercised in interpreting tuberculin skin test reactions in patients who have received BCG vaccine and these patients should be further evaluated for latent TB infection or TB disease as if they were not vaccinated with BCG.1, 110 CDC states that TB blood tests (interferon-gamma release assay [IGRA]) are preferred for individuals who have received the BCG vaccine, including children, since the BCG vaccine does not induce positive results when these tests are used.110
It is not known whether BCG vaccine can cause fetal harm if administered during pregnancy.1 Animal reproduction studies have not been conducted with the vaccine.1 CDC recommends that pregnant women not receive BCG vaccination pending further studies to support safety in this population.110
It is not known whether BCG vaccine is excreted in human milk.1 Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from BCG in nursing infants, a decision should be made whether to discontinue nursing or not to vaccinate, taking into account the importance of tuberculosis vaccination to the mother.1
Females and Males of Reproductive Potential
It is not known whether BCG vaccine can affect reproductive capacity.1
BCG vaccine is used in pediatric patients.1 Infants younger than 1 month of age should receive 1/2 of the usual dose.1
Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients.1 Other reported clinical experience has not identified differences in response between elderly and younger patients.1 An intact immune system is a prerequisite for BCG vaccination.1 If the immune status of an elderly patient, or any patient, is in question, withhold BCG vaccination until immune status has been evaluated.1
Local reactions are common after BCG vaccination.1
Antimicrobial agents may interfere with the development of immune response to BCG vaccine and should only be used under medical supervision.1
Immunosuppressive agents may interfere with the development of immune response to BCG vaccine and should only be used under medical supervision.1
Since BCG is a live vaccine, the immune response to the vaccine may be impaired if administered within 30 days of another live vaccine.1 However, there is no evidence currently available to support this concern.1 Whenever possible, the manufacturer states that live vaccines administered on different days should be administered at least 30 days apart.1
BCG vaccine is a lyophilized preparation of live, attenuated organisms of the Calmette-Guérin strain of Mycobacterium bovis .1 BCG vaccine commercially available in the US contains the TICE substrain of BCG and is administered by percutaneous administration via a multiple-puncture device.1
Vaccination with BCG promotes trained immunity mediated by innate immune cells such as monocytes, macrophages, and natural killer cells.125
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, for percutaneous use | 1-8 × 108 CFU of BCG bacillus | BCG Vaccine® | Merck Sharp and Dohme |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions August 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
1. Merck Sharp and Dohme. BCG vaccine bacillus calmette-guerin substrain tice live antigen injection for percutaneous use prescribing information. Durham, NC; 2022 Aug.
100. Anon. Disseminated Mycobacterium bovis infection from BCG vaccination of a patient with acquired immunodeficiency syndrome. MMWR Morb Mortal Wkly Rep . 1985; 34:227-8. [PubMed 3920493]
104. Centers for Disease Control Immunization Practices Advisory Committee (ACIP). Immunization of children infected with human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR Morb Mortal Wkly Rep . 1987; 35:595-606.
105. Von Reyn CF, Clements CJ, Mann JM. Human immunodeficiency virus infection and routine childhood immunisation. Lancet . 1987; 2:669-72. [PubMed 2887950]
110. Centers for Disease Control and Prevention (CDC). Bacille Calmette-Guérin (BCG) Vaccine for Tuberculosis (updated January 31, 2025). From CDC website. [Web]
111. Jensen PA, Lambert LA, Iademarco MF, Ridzon R; CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep. 2005 Dec 30;54(RR-17):1-141. PMID: 16382216.
112. Centers for Disease Control and Prevention. The role of BCG vaccine in the prevention and control of tuberculosis in the United States: a joint statement by the Advisory Council for the Elimination of Tuberculosis and the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep . 1996; 45(No. RR-4):1-18. [PubMed 8531914][Fulltext MMWR]
113. Ninane J, Grymonprez A, Burtonboy G et al. Disseminated BCG in HIV infection. Arch Dis Chil . 1988; 63:1268-9.
114. Tardieu M, Truffot-Pernont C, Carriere JP et al. Tuberculous meningitis due to BCG in two previously healthy children. Lancet . 1988; 1:440-1. [PubMed 2893868]
120. Armbruster C, Junker W, Vetter N et al. Disseminated Bacille Calmette-Guérin infection in an AIDS patient 30 years after BCG vaccination. J Infect Dis . 1990; 162:1216. [PubMed 2230251]
121. Boudes P, Sobel A, Deforges L et al. Disseminated Mycobacterium bovis infection from BCG vaccination and HIV infection. JAMA . 1989; 262:2386. [PubMed 2677428]
122. Center for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices (ACIP): use of vaccines and immune globulins in persons with altered immunocompetence. MMWR Morb Mortal Wkly Rep . 1993; 42(No. RR-4):6. [Fulltext MMWR]
123. Bass JB Jr, Farer LS, Hopewell PC et al. Treatment of tuberculosis and tuberculosis infection in adults and children. American Thoracic Society and the Centers for Disease Control and Prevention. Am J Respir Crit Care Med . 1994; 149:1359-74. [PubMed 8173779]
125. Chen J, Gao L, Wu X et al. BCG-induced trained immunity: history, mechanisms and potential applications. J Transl Med. 2023 Feb 10;21(1):106. doi: 10.1186/s12967-023-03944-8. PMID: 36765373; PMCID: PMC9913021.
187. Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR Morb Mortal Wkly Rep . 2000; 49(No. RR-6):1-54. [PubMed 10993565][Fulltext MMWR]