WHO国际疫苗标准物质和中国国家疫苗标准物质的研究进展

Research progress on WHO international standards and Chinese national standards for vaccines

疫苗标准物质是疫苗生产、质量控制、签发和评价的标尺,对疫苗质量控制发挥重要作用。世界卫生组织(World Health Organization,WHO)国际疫苗标准物质由WHO生物制品标准化专家委员会(Expert Committee on Biological Standardization,ECBS)年度会议立项及审核批准,主要研制和分发机构为英国国家生物制品检定所(National Institute for Biological Standards and Control,NIBSC)。中国国家疫苗标准物质由中国食品药品检定研究院(National Institutes for Food and Drug Control,NIFDC)研制和分发。本文分析了2016—2023年WHO ECBS系列技术报告、中国食品药品检定研究院发布的标准物质信息及国际和国家标准物质相关研究报道,从标准物质研制和分发机构、建立程序、研制技术要求和研制品种类型等方面,总结和比较了WHO国际疫苗标准物质和中国国家疫苗标准物质的研制进展,旨在提出未来国家疫苗标准物质研制和应用方向。

Reference materials used for vaccine are a kind of"ruler"for vaccine production,quality control,issuance and evaluation,which play an important role in the quality control of vaccines.World Health Organization(WHO)international standards for vaccine are set and approved by the WHO Expert Committee on Biological Standardization(ECBS)at its annual meetings,and researched and distributed mainly by National Institute for Biological Standards and Control(NIBSC)in UK.While in China,the national standards for vaccine are developed and distributed by the National Institutes for Food and Drug Control(NIFDC).This paper analyzed data from 2016 to 2023,including WHO ECBS technical series reports,information of standards released by the NIFDC and the related studies about international and national standards,from the aspects of development and distribution institutes,establishment procedures,development technical requirements and types of reference material,to summarize and compare the research progress on WHO international standards and Chinese national standards for vaccines,in order to put forward the development and application'direction of Chinese national standards for vaccines in the future.