季节性流感疫苗毒株药学变更管理的探讨  

Discussion on the Management of Pharmaceutical Changes in Seasonal Influenza Vaccine Strain

作　　者：尹姣 李茜 俞娟 曾畅 樊婉莹 马环 潘海龙 YIN Jiao;LI Qian;YU Juan;ZENG Chang;FAN Wan-ying;MA Huan;PAN Hai-long(Wuhan Institute of Biological Products Co.,Ltd.;Chengdu Institute of Biological Products Co.,Ltd.;China National Biotec Group Co.,Ltd.)

机构地区：[1]武汉生物制品研究所有限责任公司 [2]成都生物制品研究所有限责任公司 [3]中国生物技术股份有限公司

出　　处：《中国食品药品监管》2024年第6期40-45,共6页China Food & Drug Administration Magazine

摘　　要：世界卫生组织(WHO)每年都会对全球流行性感冒病毒进行监测,并给出相应指引,引导当年季节性流感疫苗的生产。疫苗生产企业每年根据WHO推荐的流行性感冒病毒生产当季流感疫苗。对于季节性流感疫苗毒株的变更,涉及流行性感冒监测系统,数据收集分析,疫苗株推荐,类似株/种子株筛选及分发、扩增制备,疫苗生产及检定、分发、接种等多个环节,疫苗生产企业如何进行变更管理,关系到疫苗的安全性、有效性和质量可控性。本文就季节性流感疫苗毒株药学变更的国内外法规要求、国内季节性流感疫苗毒株药学变更现状、毒株变更开展的药学工作进行了探讨,以期为疫苗生产企业季节性流感疫苗毒株药学变更管理提供参考,同时也为其他疫苗毒株药学变更管理提供思路。Every year,the World Health Organization(WHO)monitors influenza strains around the world and provides corresponding guidelines to guide the production of seasonal influenza vaccines for the year.Vaccine manufacturers produce seasonal influenza vaccines every year based on influenza strains recommended by the WHO.The changes of influenza vaccine strains involve multiple stages,including the influenza monitoring system,data collection and analysis,vaccine strain recommendation,screening and distribution of similar/seed strains,seed lot amplification and preparation,vaccine production,testing,distribution,and vaccination.How enterprises manage the change of influenza vaccine strains is crucial to the safety,efficacy,and quality control of vaccines.This paper discusses the domestic and international regulatory requirements for influenza strains changes,the current status of domestic influenza strain changes,and the pharmaceutical work carried out for strain changes.The aim is to guide the change management of influenza strains in enterprises and to provide references for the change management of other vaccine strains.

关 键 词：流行性感冒病毒 毒株 季节性流感疫苗 变更管理 药学变更 

分 类 号：R95[医药卫生—药学]