关于预防性人用疫苗国家标准物质的思考  

Reflections on national reference materials of preventive human vaccines

作　　者：王一平[1] 赵宗阁[1] 吴星[1,2] 梁争论 毛群颖[1,2] WANG Yiping;ZHAO Zongge;WU Xing;LIANG Zhenglun;MAO Qunying(National Institutes for Food and Drug Control,Bejing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京102629

出　　处：《中国生物制品学杂志》2023年第11期1281-1285,共5页Chinese Journal of Biologicals

基　　金：国家科技重大专项(2018ZX09101-001);中国医学科学院医学与健康科技创新工程项目(2021-I2M-5-005)。

摘　　要：生物制品国家标准物质包括疫苗、治疗和诊断试剂3类标准物质,其中疫苗类国家标准物质对疫苗生产、签发和监督检验具有重要作用。近年,我国疫苗行业发展迅速,mRNA等新技术平台在疫苗行业的应用,进一步凸显了提升我国疫苗类国家标准物水平的紧迫性。本文参考世界卫生组织(World Health Organization,WHO)对疫苗类标准物质的研制要求,列举SARS-CoV-2中和抗体标准物质建立的实例,归纳对我国疫苗类国家标准物质的思考,提出非溯源WHO国际标准物质(international standard,IS)疫苗类国家标准物质的优先建立原则,为进一步提升我国疫苗国家标准物质的研制和应用水平提供思路。The national standards for biological products include three types of reference materials,vaccines,biotherapeutics,and diagnostics,among which the national standards for vaccines play a crucial role in the production,issuance,and supervision inspection of vaccines.In recent years,the vaccine industry in China has developed rapidly,and especially,the application of new technology platforms such as mRNA in vaccines has highlighted the urgency of further improving the level of national standards for vaccines in China.Referring to WHO(World Health Organization)development requirements for reference materials of vaccines and taking Chinese national standard for SARS-CoV-2 neutralizing antibody as example,this paper summarized the thinking on national standards for vaccines in China,and presented the priority principles of establishing national standards for vaccines which are not traceable to WHO international standard(IS),in view to provide ideas for the further improvement of development and application of national standards for vaccines in China.

关 键 词：疫苗 标准物质 协作标定 

分 类 号：R194[医药卫生—卫生事业管理]