Bcg Vaccine

— THERAPEUTIC CATEGORIES —
  • Immunization
  • Vaccines
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Bcg Vaccine Generic Name & Formulations

    General Description

    Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis live, attenuated culture preparation; contains 1–8x10^8 colony forming units (CFU); per vial; freeze-dried cake for percutaneous use after reconstitution; preservative-free; contains lactose.

    Manufacturer

    Merck & Co., Inc.

    Bcg Vaccine Indications

    Bcg Vaccine Dosage and Administration

    Bcg Vaccine Contraindications

    Not Applicable

    Bcg Vaccine Boxed Warnings

    Not Applicable

    Bcg Vaccine Warnings/Precautions

    Not Applicable

    Bcg Vaccine Pharmacokinetics

    See Literature

    Bcg Vaccine Interactions

    Not Applicable

    Bcg Vaccine Adverse Reactions

    Not Applicable

    Bcg Vaccine Clinical Trials

    See Literature

    Bcg Vaccine Note

    Not Applicable

    Bcg Vaccine Patient Counseling

    See Literature

    Bcg Vaccine Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis live, attenuated culture preparation; contains 1–8x10^8 colony forming units (CFU); per vial; freeze-dried cake for percutaneous use after reconstitution; preservative-free; contains lactose.

    Pharmacological Class

    BCG Live.

    How Supplied

    Single-dose vial—1

     

    Storage

    • Store refrigerated at 2–8°C (36–46°F). Protect from direct sunlight.

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    NO

    Bcg Vaccine Indications

    Indications

    Prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. 

    Indications

    Indications and Usage

    • For the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure.

    Advisory Committee on Immunization Practices (ACIP) and the Advisory Committee for the Elimination of Tuberculosis Recommendations

    • TB Exposed Tuberculin Skin Test-Negative Infants and Children:

      • BCG vaccination is recommended for infants and children with negative tuberculin skin tests who are (a) at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patient with infectious pulmonary tuberculosis and who cannot be removed from the source of exposure and cannot be placed on long-term primary preventive therapy, or (b) continuously exposed to persons with infectious pulmonary tuberculosis who have bacilli resistant to isoniazid and rifampin, and the child cannot be separated from the presence of the infectious patient.

    • TB Exposed Health Care Workers (HCW) in High Risk Settings:

      • Consider BCG vaccination on an individual basis in settings where (a) a high percentage of TB patients are infected with M. tuberculosis strains resistant to both isoniazid and rifampin, (b) transmission of such drug resistance M. tuberculosis strains to HCWs and subsequent infection are likely, and (c) comprehensive TB infection control precautions have been implemented and have not been successful.

      • Vaccination should not be required for employment or for assignment of HCWs in specific work areas.

    • Exposed Health Care Workers in Low Risk Settings:

      • It is NOT recommended to give BCG vaccination for HCWs in low risk settings.

    Bcg Vaccine Dosage and Administration

    Adults and Children

    Reserve for persons with a reaction of <5mm induration after skin testing with 5 tuberculin units (TU) of PPD tuberculin (preferred method is the Mantoux skin-test). Give by percutaneous route using a multiple puncture device into the deltoid. Clean the inj site area using an alcohol swab(s) and allow skin to dry thoroughly. Drop the immunizing BCG vaccine dose of 0.2–0.3mL onto the vaccination site and spread using the multiple puncture device; may add additional 1–2 drops to ensure a very wet vaccination site. Cover the site with loose gauze and keep dry for 24hrs. Document tuberculin reactivity resulting from BCG vaccination. Perform tuberculin skin test 2–3 months after vaccination; if tuberculin negative, repeat vaccination after 2–3 months. Infants <1mo: reduce vaccine dose by ½; if tuberculin negative after vaccination, give full dose after 1yr of age. TB exposed tuberculin skin test-negative infants and children: give BCG vaccine. TB exposed health care workers in high risk settings: consider BCG vaccination on an individual basis. Health care workers in low risk settings: BCG vaccine is not recommended.

    Adults and Children

    Preparation of Agent

    • Do not prepare parenteral drugs in areas where BCG Vaccine has been prepared.

    • The pharmacist or individual responsible for mixing the agent should wear gloves and take precautions to avoid contact of BCG with broken skin. Wear a mask and gown if preparation cannot be performed in a biocontainment hood.

    • Use aseptic methods, add 1mL of Sterile Water for Injection to one vial of vaccine. Gently swirl the vial. Avoid forceful agitation.

    Treatment and Schedule

    • Reserve for persons with a reaction of <5mm induration after skin testing with 5 tuberculin units (TU) of PPD tuberculin (preferred method is the Mantoux skin-test).

    • Recommended to perform a Mantoux skin-test prior to BCG vaccination to prove the absence of TB infection.

    • Do not vaccinate individuals previously infected with M. tuberculosis.

    • Give percutaneously using a multiple puncture device into the deltoid. 

    • Clean the inj site area using an alcohol swab(s) and allow skin to dry thoroughly. Positive the arm to maintain a horizontal surface where the vaccine is to be placed.

    • Drop the immunizing BCG vaccine dose of 0.2–0.3mL onto the vaccination site and spread over a 1” by 2” area using the smooth edge of the multiple puncture device.

    • Grasp the arm firmly from underneath. Center the multiple puncture device over the vaccine and apply firm downward pressure.

    • Maintain pressure for 5 seconds. Do not “rock” the device. Release the pressure underneath the arm and remove the device. If the procedure is successful, the points puncture the skin.

    • After successful puncture, spread vaccine evenly over the puncture area with the smooth edge of the device. May add additional 1–2 drops to ensure a very wet vaccination site. 

    • Loosely cover the site with gauze and keep dry for 24hrs. 

    • Document tuberculin reactivity resulting from BCG vaccination. Perform tuberculin skin test 2–3 months after vaccination; if tuberculin negative, repeat vaccination after 2–3 months.

    • Infants <1mo: reduce vaccine dose by ½; if tuberculin negative after vaccination, give full dose after 1yr of age.

    • TB exposed tuberculin skin test-negative infants and children: give BCG vaccine.

    • TB exposed health care workers in high risk settings: consider BCG vaccination on an individual basis.

    • Health care workers in low risk settings: do not give BCG vaccine.

    Bcg Vaccine Contraindications

    Contraindications

    Immunocompromised due to HIV infections, congenital immunodeficiency (eg, chronic granulomatous disease or interferon gamma receptor deficiency, leukemia, lymphoma, or generalized malignancy). Immunosuppressed due to steroids, alkylating agents, antimetabolites, or radiation. Active TB. Severe immune deficiency syndromes. Children with family history of immune deficiency disease.

    Bcg Vaccine Boxed Warnings

    Not Applicable

    Bcg Vaccine Warnings/Precautions

    Warnings/Precautions

    Do not inject by IV, SC, IM or intradermal route. Do not administer to individuals previously infected with M. tuberculosis. Have epinephrine (1:1000) available. Vaccinate only if tuberculin negative to a recent skin test with 5 TU. Persons in groups at high risk for HIV infection or attributing a positive skin test to BCG vaccination: use caution. Acute, localized irritative toxicities; evaluate and consult expert for serious infectious complications if symptoms (eg, fever ≥103°F) or acute localized inflammation longer than 2–3 days occur. Initiate anti-TB therapy if systemic BCG infection occurs and consult expert. Pregnancy, nursing mothers: not recommended.

    Warnings/Precautions

    • Do not inject by IV, SC, IM or intradermal route.

    • Post-vaccination reactions may include moderate axillary or cervical lymphadenopathy and induration and subsequent pustule formation at the injection site. These reactions can persist for up to 3 months.

    • Severe local reactions include ulceration at the vaccination site, regional suppurative lymphadenitis with draining sinuses, and caseous lesions or purulent drainage at the puncture site.

    • Acute, localized irritative toxicities may be accompanied by systemic manifestations, consistent with a “flu-like” syndrome. 

      • Consider evaluating for serious infection complication if symptoms (eg, fever ≥103°F) or acute localized inflammation persisting longer than 2–3 days occur. Consult infectious disease expert if a BCG infection is suspected prior to initiating therapy.

      • Initiate 2 or more antimycobacterial agents in patients who develop persistent fever or experience an acute febrile illness consistent with BCG infection.  

    • Most serious complication of BCG vaccination is disseminated BCG infection.

    • Do not prepare parenteral drugs in areas where BCG vaccine has been in use to avoid cross-contamination.

    • Do not administer to individuals with severe immune deficiency disease.

    • Use caution when administering to persons in groups at high risk for HIV infection.

    • Prior to vaccination, review each individual’s immunization records to include history on reactions to immunizations.

    • Have epinephrine injection (1:1000) available for immediate allergic reactions or acute anaphylactic reactions.

    • Only vaccinate those who are tuberculin negative to a recent skin test with 5 TU.

    • Use caution in attributing a positive skin test to BCG vaccination. Evaluate further if a sharp rise in the tuberculin reaction since the latest test occurs (except in the immediate post-vaccination period).

    Pregnancy Considerations

    • BCV Vaccine is not recommended for use during pregnancy.

    • No animal reproductive studies have been conducted.

    • Not known whether BCG vaccine can cause fetal harm to a pregnant woman or can affect reproductive capacity.

    Nursing Mother Considerations

    • Not known whether BCG is excreted in human milk.

    • A decision should be made whether to discontinue nursing or not to vaccinate, taking into account the importance of tuberculosis vaccination to the mother.

     

    Geriatric Considerations

    • Clinical studies of BCG Vaccine did not include a sufficient number of patients 65 years of age and older.

    • If the immune status of an elderly patient, or any patient, is in question, the BCG vaccination should be held until the immune status of the patient has been evaluated.

    Other Considerations for Specific Populations

    • Do not administer the BCG Vaccine to individuals with HIV infection.

    Bcg Vaccine Pharmacokinetics

    See Literature

    Bcg Vaccine Interactions

    Interactions

    Do not prepare parenteral drugs in areas where BCG vaccine has been in use to avoid cross-contamination. BCG vaccination results in tuberculin skin test reactivity; do not vaccinate in individuals with a positive tuberculin skin test. Concomitant use with antimicrobials or immunosuppressive agents may interfere with immune response; only use under medical supervision. Separate live vaccines by at least 30 days if possible.

    Bcg Vaccine Adverse Reactions

    Adverse Reactions

    Localized irritative toxicities (eg, “flu-like” syndrome, fever, anorexia, myalgia, neuralgia), BCG osteomyelitis; disseminated BCG infection.

    Bcg Vaccine Clinical Trials

    Clinical Trials

    Prospective Trial

    • A prospective trial evaluated the TICE strain of BCG Vaccine in 1716 vaccinated and 1665 non-vaccinated infants who were all born at the Cook County Hospital in Chicago and followed for 12-23 years.

    • The vaccinated arm had 17 cases of tuberculosis (0.43/1000/yr) vs 65 cases in the nonvaccinated arm (1.7/1000/yr), which corresponds to a 75% reduction in cases of tuberculosis (P <.001).

    • 8 of the 790 vaccinated patients developed tuberculosis compared with 30 of the 945 patients (P <.001).

    1995 Study

    • A 1995 study evaluated the vaccine potency of BCG Vaccine (TICE strain) in 26 tuberculin negative patients and subsequent tuberculin conversion was monitored.

    • 24 patients returned for follow-up testing with PPD 10 TU 8 weeks after vaccination. 22 of the 24 patients converted to positive and 2 remained negative.

    • The conversion rate was 92% and the average positive skin test reading was 15.5mm in induration.

    Second Study

    • 22 volunteers who were 18 to 40 years of age received a standard dose of BCG Vaccine (TICE strain). Volunteers were not health care worker, were not foreign born, were HIV negative, and were negative responders to a 10 TU PPD skin test. Volunteers returned for a 10 TU skin test 8 weeks after vaccination.

    • The conversion rate of 95%.

    Bcg Vaccine Note

    Not Applicable

    Bcg Vaccine Patient Counseling

    Patient Counseling

    • Inform patients of the benefit and risk of immunization and inquire about the health status of the patient.

    • Inform patients about:

      • Variable data for the efficacy of BCG vaccination.

      • The interference with the diagnosis of newly acquired M. tuberculosis infection in BCG-vaccinated persons, and

      • The potential serious complications associated with BCG vaccination of immunocompromised individuals.

    • Inform health care workers about:

      • The lack of data regarding the efficacy of preventive therapy for MDR-TB infections, and

      • The risk of drug toxicity associated with multi-drug preventive therapy regimens.

    • No dressing is required after BCG vaccination; the site should be loosely covered and kept dry for 24 hours.

    • Initial skin lesions typically appear within 10–14 days post-vaccination and may appear as small red papules at the site.

    • Patients may experience “flu-like symptoms for 24–48 hours following BCG vaccination. Consult physician immediately if fever if fever ≥103°F or acute local reactions persist longer than 2–3 days.

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