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世界卫生组织 (WHO)正在对评价和批准新型肺炎球菌结合疫苗 /联合疫苗或不同免疫程序的血清学标准进行一系列评议。由于缺乏明确的保护作用血清学相关物及疫苗中含有多个抗原 ,尤其是唯一获得批准的疫苗所含各血清型大多未建立临床效力数据 ,从而阻碍了批准新疫苗或联合疫苗的标准的制订。本文对各种观点进行了分析 ,并向管理当局提供评价这些待批准疫苗的初步指南性建议。关于肺炎球菌结合疫苗生产与质控更详细的建议 ,包括评价和审批标准正在拟定中。
The World Health Organization (WHO) is conducting a series of reviews on the serological criteria for evaluating and approving new pneumococcal conjugate / combination vaccines or different immunization programs. The absence of a definitive protective role Many serological related and vaccine vaccines contain multiple antigens, and most of the serotypes included in the only approved vaccine, for the most part, lack established clinical efficacy data that have hampered the approval of new or combined vaccine standards . This article analyzes the various points of view and provides regulatory authorities with preliminary guidance to evaluate these pending vaccines. More detailed recommendations on the production and quality control of pneumococcal conjugate vaccines, including the criteria for evaluation and approval, are under development.