Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety

Bull World Health Organ. 1990;68(1):93-108.

Abstract

WHO oversees the quality control of BCG vaccine via a system that includes regular testing of products by in vitro methods and clinical trials. Three parent strains of BCG (Glaxo-1077, Tokyo-172, and Pasteur-1173P2) account for over 90% of the vaccines currently in use worldwide. Important characteristics of the vaccine preparations are summarized here, along with their physical-chemical properties. In instances where diagnostic criteria for tuberculosis are stringent, there is no evidence that when administered to newborns different preparations of BCG vaccine exhibit different efficacies; however, the incidence of BCG-associated adverse reactions does correlate with the type of preparation. Other factors, including dose, administration technique, and recipient characteristics are also important in determining vaccine-associated reactions.

Publication types

  • Clinical Trial

MeSH terms

  • BCG Vaccine / adverse effects
  • BCG Vaccine / standards*
  • BCG Vaccine / supply & distribution
  • Chemistry, Pharmaceutical
  • Clinical Trials as Topic
  • Humans
  • International System of Units
  • Lymphadenitis / chemically induced
  • Lymphadenitis / epidemiology
  • Osteitis / chemically induced
  • Osteitis / epidemiology
  • Quality Control*
  • World Health Organization*

Substances

  • BCG Vaccine