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The Outcome of Accidental Bacille Calmette-Guérin Overdose During Routine Neonatal Immunization

Leonore Greybe1, July L Morrison, H Simon Schaaf

  • 1From the Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.

The Pediatric Infectious Disease Journal
|January 20, 2021
PubMed

Insights

Newborn infants accidentally received a high dose of the tuberculosis vaccine, Bacille Calmette-Guérin. Subsequent treatment with isoniazid and rifampicin showed only mild local adverse reactions, with all infants recovering fully within six months.

Area of Science:

  • Pediatric infectious diseases
  • Immunization safety
  • Tuberculosis prevention

Background:

  • Bacille Calmette-Guérin (BCG) is a widely used vaccine for tuberculosis prevention.
  • Accidental high-dose administration of vaccines can pose safety concerns.

Purpose of the Study:

  • To evaluate the outcomes and adverse reactions in newborn infants who received an overdose of Bacille Calmette-Guérin vaccine.
  • To assess the safety and efficacy of subsequent high-dose isoniazid and rifampicin preventive therapy.

Main Methods:

  • Retrospective study design.
  • Inclusion of 14 newborn infants who received 62.5 times the recommended BCG dose.
  • Administration of high-dose isoniazid and rifampicin (20 mg/kg/d each) for 6 months.

Main Results:

  • All infants experienced mild local adverse reactions.
  • One-third of adverse reactions resolved within 16 weeks.
  • All adverse reactions resolved by 6 months.

Conclusions:

  • High-dose Bacille Calmette-Guérin administration in newborns resulted in mild, transient local adverse reactions.
  • High-dose isoniazid and rifampicin preventive therapy was well-tolerated in this cohort.
  • The safety profile suggests that prompt medical intervention can mitigate risks associated with BCG overdose.

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