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
刘晶晶 1张来俊 2付非 3李珉 1李玉立 1何欢 1王前硕 2董晨迪 2叶祥忠 4姜金奇 4李文东1
作者信息
- 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
- 折叠
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.
Abstract
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Key words
nasal spray vaccine/COVID-19 vaccine/recombinant virus vector/production quality super-vision引用本文复制引用
基金项目
北京市科技新星计划资助项目(Z211100002121007)
出版年
2024
NETL
NSTL
万方数据