BCG Vaccination Dose and Administration in Newborns and Infants
Recommended Dose
For infants up to 12 weeks of age, the standard BCG vaccine dose is 0.1 mL (containing the Tice strain in the United States) administered percutaneously via multiple-puncture disc to the lower deltoid area, with infants under 30 days of age receiving half this dose (0.05 mL prepared by increasing diluent) if vaccination is indicated. 1
The 0.1 mL dose at birth has been shown to produce significantly better tuberculin reactivity, tuberculin positivity, and mean scar size compared to the 0.05 mL dose, supporting continuation of the full dose practice. 2
Infants under 30 days of age should receive 0.05 mL (half dose), prepared by doubling the amount of diluent added to the lyophilized vaccine. 1
If indications for vaccination persist after half-dose administration in neonates, these children should receive a full 0.1 mL dose after 1 year of age if tuberculin skin testing shows <5 mm induration. 1
Administration Method
The percutaneous multiple-puncture disc technique is the standard method for BCG administration in the United States, applied to the lower deltoid area (upper arm) after placing 0.3 mL of reconstituted vaccine on the skin. 1
The vaccine must be administered percutaneously using a multiple-puncture disc, NOT by intradermal or subcutaneous injection, as these routes significantly increase adverse reactions including muscular soreness, erythema, and purulent drainage. 1
Subcutaneous administration errors have been associated with severe complications including subcutaneous abscesses and deep chronic ulcers, with one study documenting 8 cases of subcutaneous abscess when injection was too deep. 3
Administering 10 times the recommended dose (1 mL instead of 0.1 mL) dramatically increases complication rates, as documented in cases where patients erroneously received 1 mL and developed extensive progressive ulceration and even humeral osteitis. 3
Pre-Vaccination Requirements
BCG vaccination must only be given to persons with tuberculin skin test induration <5 mm using 5 tuberculin units (TU) of PPD tuberculin. 1, 4
Tuberculin testing is mandatory before vaccination to avoid accelerated reactions in persons previously infected with M. tuberculosis. 1
BCG is absolutely contraindicated in immunocompromised infants, including those with congenital immunodeficiency, HIV infection (known or suspected), leukemia, lymphoma, or those receiving immunosuppressive therapy. 1, 5
If maternal HIV status is unknown or positive, infant HIV testing must be confirmed before vaccination, as disseminated BCG disease can be fatal in HIV-infected children. 1, 5
If the mother received anti-TNF biologics (infliximab, adalimumab, golimumab) during the second half of pregnancy, BCG vaccination MUST be delayed until at least 6 months of age due to transplacental transfer of these agents. 5
Vaccine Preparation
Freeze-dried BCG vaccine should be reconstituted according to manufacturer instructions, protected from light exposure, refrigerated when not in use, and used within 8 hours of reconstitution. 1
The Tice strain (Organon, Inc.) is the only BCG vaccine licensed in the United States; other BCG preparations available for bladder cancer treatment are not intended for vaccination use. 1
Post-Vaccination Care and Expected Reactions
Normal reactions include formation of a bluish-red pustule within 2-3 weeks, which ulcerates at approximately 6 weeks forming a 5 mm lesion, with healing and scar formation typically complete within 3 months. 1, 4
Draining lesions should be kept clean and bandaged throughout the healing process. 1, 4
Tuberculin skin testing should be performed 3 months after BCG administration to document tuberculin reactivity, with results recorded in millimeters of induration in the medical record. 1, 4
Hypertrophic scars occur in 28-33% of vaccinees, and keloid scars develop in approximately 2-4%. 1
Tuberculin reactivity develops 6-12 weeks after vaccination and typically wanes over time, unlikely to persist >10 years without M. tuberculosis exposure. 1
Complications and Management
The most common complication is ipsilateral regional lymphadenitis, with the most serious being disseminated BCG infection (fatal in 0.06-1.56 cases per million doses), occurring primarily in immunocompromised persons. 1
For adherent or fistulated lymph nodes, WHO recommends drainage and direct instillation of an anti-TB drug into the lesion; nonadherent lesions heal spontaneously without treatment. 1
BCG osteitis can occur 4 months to 2 years after vaccination, affecting the epiphyses of long bones, with incidence varying from 0.01 per million (Japan) to 43.4 per million (Finland). 1
If disseminated BCG disease is suspected, initiate anti-TB therapy immediately but NEVER use pyrazinamide, as all BCG strains are universally resistant to this antibiotic. 1, 5
Persistent reactions beyond 4 months post-vaccination warrant evaluation for BCG osteitis or disseminated infection. 5
Critical Timing Considerations
BCG vaccination timing should not interfere with other routine infant immunizations, though BCG is rarely indicated in the United States and should only be considered after consultation with TB control programs. 1, 4, 5
The standard childhood vaccination schedule (hepatitis B at birth, followed by DTaP, Hib, PCV, IPV, and rotavirus starting at 6 weeks) takes precedence in the United States where TB prevalence is low. 6
In countries where BCG is part of routine immunization, WHO recommends administration to all infants in TB-endemic areas, with approximately 120 million doses administered worldwide annually. 7
Special Populations
Preterm infants (26-37 weeks gestational age) and low birth weight infants (0.69-2.5 kg) can safely receive BCG once medically stable, with safety profiles similar to term infants. 5
BCG vaccination is not recommended during pregnancy, although no harmful effects to the fetus have been definitively associated with the vaccine. 1
WHO recommends BCG for asymptomatic HIV-infected children at high risk for TB in endemic countries, but NOT for symptomatic HIV-infected children or those at minimal TB risk. 1