Risk of disseminated tuberculosis and other infections after neonatal Bacillus Calmette–Guérin vaccination in infants with in-utero exposure to tumor necrosis factor-α inhibitors - Report - MDSpire

Risk of disseminated tuberculosis and other infections after neonatal Bacillus Calmette–Guérin vaccination in infants with in-utero exposure to tumor necrosis factor-α inhibitors

  • By

  • Samar Al Emadi

  • Seham Alebbi

  • Nawal Hadwan

  • Omar Alsaed

  • Priyanka Moovara Cackamvalli

  • Nevin Abunahia

  • Eman Satti

  • June 8, 2026

  • 0 min

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Evaluating the Risk of Disseminated Tuberculosis Following BCG Vaccination

Overview

This study assessed the safety of Bacillus Calmette–Guérin (BCG) vaccination at birth in infants exposed in utero to tumor necrosis factor-alpha (TNF-α) inhibitors. Findings indicate that BCG vaccination did not result in disseminated tuberculosis or increased risk of infections during the first year of life.

Background

Infants born to mothers treated with TNF-α inhibitors during pregnancy may face risks associated with immunosuppression, particularly concerning live vaccines like BCG. Recent guidelines recommend delaying live vaccinations in this population due to potential safety concerns. Understanding the implications of BCG vaccination in this context is crucial for optimizing infant health outcomes.

Data Highlights

ParameterValue
Infants exposed to TNF-α inhibitors63
Infants vaccinated with BCG49 (77.8%)
Infants vaccinated at birth27 (42.8%)
Infants with at least three infectionsOver 50%
Cases of disseminated tuberculosis0

Key Findings

  • 63 infants were identified who were exposed to TNF-α inhibitors in utero.
  • 77.8% of these infants received BCG vaccination within the first year of life.
  • 42.8% of infants were vaccinated at birth, with most exposed during the third trimester.
  • Over half of the infants experienced at least three infections, but none developed disseminated tuberculosis.
  • Exposure to TNF-α inhibitors did not increase the risk of infection or hospitalization during infancy.

Clinical Implications

The findings support the safety of administering BCG vaccination at birth in infants exposed to TNF-α inhibitors, alleviating concerns regarding disseminated tuberculosis. Clinicians can consider this evidence when making vaccination decisions for this vulnerable population.

Conclusion

BCG vaccination at birth appears safe for infants exposed to TNF-α inhibitors in utero, with no cases of disseminated tuberculosis reported. This study contributes valuable data to the ongoing discussion about vaccination practices in this context.

Related Resources & Content

  1. The Journal of Infectious Diseases, 2023 -- Does Systemic Spread of BCG After Neonatal Vaccination Enhance Protection Against Mycobacterium tuberculosis?
  2. Clinical Rheumatology, 2010 -- Evaluating Interferon-Gamma Release Assays Versus Tuberculin Skin Tests in Patients with Refractory Inflammatory Diseases for Latent Tuberculosis Screening Before Starting TNFα Inhibitor Therapy
  3. Infection, 2022 -- Tuberculosis Cases Reported in a Daycare Center in Germany
  4. Ann Rheum Dis, 2025 -- EULAR recommendations on antirheumatic drugs in reproduction and lactation
  5. Open Forum Infectious Diseases — Reduced T-cell Responses Specific to Mycobacterium tuberculosis in Pregnant Women with HIV Undergoing Isoniazid Preventive Therapy
  6. Australian Immunisation Handbook -- Infants exposed to immunosuppressive therapy in utero or through breastmilk
  7. Ann Rheum Dis 84 (2025) 910−926
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  11. Incidence, risk factors and outcomes of BCGosis following BCG vaccination in infants: a systematic review and meta-analyses - PubMed
  12. Rapidly Progressive Disseminated Bacillus Calmette-Guérin Infection (BCGitis) in a 3-Month-Old Infant Without Immunodeficiency: A Case Report - PubMed
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