Milstien J B, Gibson J J
Biologicals Unit, World Health Organization, Geneva, Switzerland.
Bull World Health Organ. 1990;68(1):93-108.
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.
世界卫生组织通过一个系统监督卡介苗的质量控制，该系统包括通过体外方法对产品进行定期检测和临床试验。三种卡介苗亲本菌株（葛兰素-1077、东京-172和巴斯德-1173P2）占目前全球使用疫苗的90%以上。在此总结疫苗制剂的重要特征及其物理化学性质。在结核病诊断标准严格的情况下，没有证据表明给新生儿接种不同制剂的卡介苗时会表现出不同的效力；然而，卡介苗相关不良反应的发生率确实与制剂类型相关。其他因素，包括剂量、接种技术和受种者特征，在确定疫苗相关反应方面也很重要。
