Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety.
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.
Biologicals Unit, World Health Organization, Geneva, Switzerland.
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JB
Milstien
J J
JJ
Gibson
D001500:BCG Vaccine / Q000009:adverse effects / Q000592:standards* / Q000600:supply & distribution; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D006801:Humans; D007394:International System of Units; D008199:Lymphadenitis / Q000139:chemically induced / Q000453:epidemiology; D010000:Osteitis / Q000139:chemically induced / Q000453:epidemiology; D011786:Quality Control; D014944:World Health Organization
D001500:BCG Vaccine