BCG Vaccine AJVaccines is a live attenuated bacterial vaccine containing Mycobacterium bovis Bacille Calmette-Guerin, Danish strain 1331, supplied as a lyophilised powder and solvent for intradermal injection at 2-8 x 10^6 colony-forming units per millilitre after reconstitution. The vaccine induces a controlled local mycobacterial infection that elicits durable cell-mediated immunity (CD4+ Th1 lymphocyte response, macrophage activation, IFN-gamma and TNF-alpha mediated granuloma formation) that protects against severe forms of tuberculosis, particularly miliary tuberculosis and tuberculous meningitis in infants and children. ATC class J07AN01 (vaccines, mycobacterial). Protective efficacy against pulmonary tuberculosis in adults is variable across regions but consistent against severe paediatric forms.
⚠️ Warnings
Administered only by trained personnel using strict intradermal injection technique (subcutaneous injection causes excessive ulceration and lymphadenitis). Reconstitute strictly according to manufacturer instructions and use within the specified window. Screen for cellular immunodeficiency before vaccination of infants of HIV-positive mothers in TB-endemic regions. Do not vaccinate during febrile illness > 38 degrees C. Avoid skin areas with active dermatosis. Tuberculin skin test (or IGRA) before vaccination is recommended in older children, adolescents and adults to exclude prior infection. Inform parents that local reactions are expected and require simple dry care, not topical antiseptics or antibiotics. Refer suspected BCG osteitis or disseminated BCG infection to specialist care for prolonged antimycobacterial therapy.