Recommendations for pediatric tuberculosis vaccination in Italy

Area of Science:

• Immunology
• Vaccinology
• Public Health

Background:

• Bacillus Calmette-Guérin (BCG) is the sole approved vaccine for tuberculosis (TB) prevention.
• Global recommendations for BCG vaccination vary, necessitating country-specific guidelines.
• Italian scientific societies convened to establish pediatric BCG vaccination recommendations.

Purpose of the Study:

• To outline Italian expert recommendations for pediatric BCG vaccination.
• To assess the duration of BCG vaccine protection.
• To evaluate BCG vaccine safety and its impact on tuberculin skin test (TST) responses.

Main Methods:

• Review of existing scientific literature and expert consensus.
• Analysis of BCG vaccine efficacy against different TB manifestations.
• Assessment of vaccine safety in immunocompetent individuals.

Main Results:

• BCG vaccination provides good protection against tuberculous meningitis and disseminated TB, and fair protection against pulmonary TB.
• Protective efficacy persists for at least 10 years; revaccination shows no added benefit.
• The vaccine is safe in immunocompetent subjects and affects TST responses for at least 6 years.

Conclusions:

• BCG vaccination is recommended for TST-negative, immunocompetent infants and children in Italy, particularly those with increased TB exposure risk.
• Targeted vaccination strategies are advised for newborns, infants under 6 months, and children up to 5 years from high-risk groups.
• The findings support continued BCG use in specific pediatric populations based on efficacy and safety data.