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Screen first, vaccinate later: Enhancing tuberculosis vaccination safety through newborn immunodeficiency screening

Gregor Nosan1, Andreja Cerkvenik Škafar2

  • 1Department of Neonatology, Division of Paediatrics, University Medical Centre Ljubljana, Bohoričeva ulica 20, 1000 Ljubljana, Slovenia; Department of Paediatrics, Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia.

Vaccine
|September 4, 2025
PubMed

Insights

Slovenia now screens newborns for immunodeficiency before administering the Bacillus Calmette-Guérin (BCG) vaccine, enhancing tuberculosis (TB) prevention safety. This precision approach protects vulnerable infants while ensuring timely TB protection.

Area of Science:

  • Immunology and Infectious Diseases
  • Vaccinology
  • Public Health Policy

Background:

  • Tuberculosis (TB) remains a significant global health issue, with millions of new cases annually and challenges from multidrug-resistant strains.
  • Bacillus Calmette-Guérin (BCG) vaccination is crucial for preventing severe forms of infant TB, but carries risks for immunocompromised newborns.
  • Inborn errors of immunity (IEI) screening is vital before BCG vaccination to mitigate disseminated infection risks in vulnerable infants.

Purpose of the Study:

  • To describe Slovenia's innovative approach to integrating newborn screening for inborn errors of immunity (IEI) with neonatal Bacillus Calmette-Guérin (BCG) vaccination.
  • To highlight a precision vaccination strategy balancing timely tuberculosis (TB) protection with infant safety in a low-incidence setting.
  • To present a model for other low-incidence countries seeking to modernize TB prevention protocols.

Main Methods:

  • Implementation of universal newborn screening for inborn errors of immunity (IEI) starting in 2024.
  • Revision of the neonatal BCG vaccination protocol in 2025 to mandate IEI screening results prior to vaccination.
  • Specific timing for blood sampling (≥48 hours), result availability (days 5-7), and BCG administration (7-14 days of life).

Main Results:

  • Establishment of a revised neonatal vaccination protocol that prioritizes infant safety by identifying immunocompromised newborns before BCG administration.
  • Successful integration of real-time immunogenetic data into a targeted BCG vaccination strategy.
  • Demonstration of a feasible model for precision vaccination in a low-incidence country.

Conclusions:

  • Slovenia's integrated IEI screening and BCG vaccination protocol offers a safe and effective approach to neonatal tuberculosis prevention.
  • This precision vaccination strategy aligns with global efforts to enhance TB control and protect vulnerable populations.
  • The Slovenian model provides a valuable framework for other low-incidence nations aiming to optimize their vaccination programs.

Keywords:
Bacillus Calmette-GuérinNewbornPrimary immunodeficiency diseasesScreeningTuberculosisVaccination

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