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Adverse reactions to BCG

E Vítková1, J Galliová, K Krepela

  • 1State Institute for Drug Control, Prague, Czech Republic.

Central European Journal of Public Health
|August 1, 1995
PubMed
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The Moscow BCG vaccine, used from 1981-1993, increased adverse reactions. Lowering the dose paradoxically increased local reactions but significantly reduced regional lymph node issues and the need for further treatment.

Area of Science:

  • Immunology
  • Vaccinology
  • Public Health

Background:

  • BCG vaccine substrains used in the Czech Republic post-WWII included Copenhagen, Prague BCG 725, Moscow BCG, and Behring BCG.
  • Introduction of Moscow BCG (1981-1993) correlated with increased local/regional lymph node adverse reactions and bone/joint involvement in infants.
  • Molecular genetics can identify these BCG substrains.

Purpose of the Study:

  • To analyze post-vaccination adverse reactions associated with Moscow BCG (1981-1993).
  • To evaluate the impact of reduced vaccination dosage on adverse reaction frequency.

Main Methods:

  • Retrospective analysis of adverse reaction data for Moscow BCG vaccine use (1981-1993).
  • Comparison of adverse event rates between full (0.05 mg) and reduced (0.025 mg) BCG vaccination doses.

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  • Data collection on local, regional lymph node, and bone/joint complications.

    • Main Results:

    • Full dose Moscow BCG: 0.08% local, 0.01% regional lymph node reactions; 6.5% required chemotherapy, 24% surgery.
    • Reduced dose Moscow BCG: 0.1% local, 0.01% regional lymph node reactions; 3.1% required chemotherapy, 4.8% surgery.
    • Bone and joint involvements occurred in 3.7 per 10^5 infants vaccinated with the full dose.

    Conclusions:

    • Reduced dosage of Moscow BCG vaccine led to a significant decrease in regional lymph node complications and subsequent medical interventions.
    • Despite a slight increase in local reactions, the lower dose demonstrated a favorable safety profile regarding severe adverse events.
    • The findings highlight the importance of vaccine dosage optimization for BCG to minimize adverse reactions while maintaining efficacy.