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Updated: Aug 26, 2026

Protective Efficacy and Pulmonary Immune Response Following Subcutaneous and Intranasal BCG Administration in Mice
Published on: September 19, 2016
Abstract:
(1) Local and regional adverse effects (ulceration, abscesses and adenitis are generally mild, although they can persist for more than three months. Systemic effects are rare but potentially life-threatening (osteitis, disseminated BCG infection, anaphylaxis, etc.). (2) Some risk factors are related to the vaccine itself or to its administration (intradermal route, certain strains of vaccine, high doses, etc.). There are very few data on the adverse effects of multipuncture BCG administration. (3) The frequency of adverse effects is inversely related to age at vaccination. The vaccine can cause severe disseminated BCG infection, especially in subjects with congenital or acquired immunodeficiency (notably HIV infection and immunosuppressive therapy). (4) The risk of adverse effects can be minimised by avoiding patients with contraindications and by careful administration.
Insights
Bacille Calmette-Guérin (BCG) vaccination can cause local adverse effects, with rare but severe systemic reactions. Risk factors include administration route and patient immunodeficiency, emphasizing careful patient selection and administration to minimize risks.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Bacille Calmette-Guérin (BCG) is a widely used vaccine for tuberculosis prevention.
- Understanding BCG vaccine's adverse effects is crucial for safe and effective immunization programs.
- Adverse events range from mild local reactions to rare, severe systemic complications.
Purpose of the Study:
- To comprehensively review the local and systemic adverse effects associated with BCG vaccination.
- To identify risk factors influencing the occurrence and severity of BCG vaccine adverse events.
- To provide guidance on minimizing BCG vaccine-related risks.
Main Methods:
- Systematic review of literature on BCG vaccine adverse effects.
- Analysis of reported cases of local and systemic reactions.
- Identification and categorization of risk factors, including vaccine characteristics, administration methods, and patient-specific factors.
Main Results:
- Local adverse effects (ulceration, abscesses, adenitis) are generally mild but can be persistent.
- Systemic adverse effects, though rare, can be life-threatening (e.g., osteitis, disseminated BCG infection, anaphylaxis).
- Risk factors include intradermal route, vaccine strain, high doses, younger age at vaccination, and immunodeficiency (HIV, immunosuppressive therapy).
Conclusions:
- BCG vaccine adverse effects are generally mild and inversely related to age.
- Severe systemic BCG infection is a significant risk in immunocompromised individuals.
- Minimizing risks involves careful patient screening for contraindications and meticulous vaccine administration.
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