摘要
目前全球新型冠状病毒肺炎疫苗(简称新冠疫苗)的研发取得积极进展,多种疫苗不断在各个国家和地区获批紧急使用授权或附条件上市,但由于新冠疫苗的研发周期较短,大规模接种后不良反应事件时有发生,人们对疫苗上市后安全性和有效性极为关注.本文将根据目前已披露的新冠疫苗Ⅲ期临床数据,对已经上市的疫苗数据资料进行比较,从疫苗上市后真实世界研究和不良反应及其应对措施等进行总结,旨在为新冠疫苗上市后评价提供参考.本文查询到的相关数据表明,目前上市的疫苗均有较好的安全性和有效性,但仍需长期不断地密切监测,强化接种后的监测和记录,制定相关策略来提高疫苗大规模接种后的有效性和安全性.
The development of COVID-19 vaccines has made positive progress worldwide,and a variety of vaccines have been continuously approved for emergency use authorization or conditionally marketed in various countries and regions,but due to the short development cycle and the occurrence of adverse reactions after mass vaccination,there are great concerns about the post-marketing safety and efficacy of the vaccine.In this paper,we will compare the vaccines that have been marketed and summarize the post-marketing real-world studies and adverse reactions and their responses based on the currently disclosed phase III clinical data of the new crown vaccine,with the aim of providing a reference for the post-marketing evaluation of the new crown vaccine.The available results indicate that all currently marketed vaccines have good safety and efficacy,but close long-term and continuous monitoring is still needed to strengthen post-vaccination monitoring and documentation and to develop relevant strategies to improve the efficacy and safety of the vaccine after mass vaccination.
作者
廖聪慧
王子晨
邓强
陆家海
LIAO Conghui;WANG Zichen;DENG Qiang;LU Jiahai(School of Public Health,Sun Yat-sen University/NMPA Key Laboratory for Quality Monitoring and Evaluation of Vaccines and Biological Products/Key Laboratory for Tropical Diseases Control of Ministry of Edhcation/One Health Center of Excellence for Research and Tranning,Cuangzhou 520030,China;School of Public Health,University of Califomia,Irvine,CA 92697,United States of America)
出处
《暨南大学学报（自然科学与医学版）》
CAS
CSCD
北大核心
2021年第5期547-556,共10页
Journal of Jinan University(Natural Science & Medicine Edition)
基金
国家重点研发计划项目(2018YFE0208000)
国家科技重大专项(2018ZX10101002-001-001)
广东省重点领域研发计划项目(2018B020241002)
广东省科技计划项目(2018B020207013)。
