浅析我国首款鼻喷新型冠状病毒疫苗生产质量监管要点  

Analysis on the key points of production quality supervision of the first nasal spray COVID-19 vaccine in China

作　　者：刘晶晶 张来俊[2] 付非 李珉 李玉立 何欢 王前硕 董晨迪 叶祥忠 姜金奇 李文东 LIU Jing-jing;ZHANG Lai-jun;FU Fei;LI Min;LI Yu-li;HE Huan;WANG Qian-shuo;DONG Chen-di;YE Xiang-zhong;JIANG Jin-qi;LI Wen-dong(Beijing Institute for Drug Control(Beijing Center for Vaccine Control),NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China;Beijing Municipal Medical Products Administration,Beijing 101117,China;Beijing Center for Drug Evaluation and Inspection(Beijing Center for Vaccine Inspection),Beijing 101117,China;Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd.,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院(北京市疫苗检验中心),国家药品监督管理局创新药物安全研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206 [2]北京市药品监督管理局,北京101117 [3]北京市药品审评检查中心(北京市疫苗检查中心),北京101117 [4]北京万泰生物药业股份有限公司,北京102206

出　　处：《中国新药杂志》2024年第14期1437-1441,共5页Chinese Journal of New Drugs

基　　金：北京市科技新星计划资助项目(Z211100002121007)。

摘　　要：黏膜免疫系统是机体抵御病毒和细菌感染的第一道防线,在抵抗感染方面发挥着重要的作用。其中鼻黏膜免疫在呼吸道传染病预防方面具有独特优势,已成为疫苗研究热点。自新型冠状病毒疫情暴发以来,新型冠状病毒疫苗研发中已有多条技术路线采用了鼻腔免疫方式。本文对我国首款鼻喷新型冠状病毒疫苗的生产质量监管要点进行总结,以期为今后鼻喷疫苗的生产质量监管提供借鉴参考。The mucosal immune system is the first line of defense against viral and bacterial infections for the body,and plays an extremely important role in resisting infections.Nasal mucosal immune vaccines,with their unique advantages in the prevention of respiratory infectious diseases,have become a hot topic in vaccine research.Since the outbreak of COVID-19,intranasal administration has been applied in different vaccine platforms.This article reviewed the key points of production quality supervision of the first nasal spray COVID-19 vaccine in China,with a view to provide a reference for the production quality supervision of nasal spray vaccines in the future.

关 键 词：鼻喷疫苗 新型冠状病毒疫苗 重组病毒载体 生产质量监管 

分 类 号：R969.4[医药卫生—药理学]