Study on Emergency Use Authorization and Risk Control of Pfizer-BioNTech Vaccine  

作　　者：Wang Yiran Yang Yue 

机构地区：[1]School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China [2]School of Pharmaceutical Science,Tsinghua University,Beijing 100084,China

出　　处：《Asian Journal of Social Pharmacy》2023年第1期24-29,共6页亚洲社会药学（英文）

摘　　要：Objective To analyze the methods and policies for emergency use authorization(EUA)and risk control of COVID-19 vaccines.Methods The legal basis,safety,and effectiveness evaluation criteria for Pfizer-BioNTech vaccine under EUA,as well as the continuation of phase III clinical trials and pharmacovigilance plans were sorted out.And attention was paid to the safety surveillance actions and risk control measures of vaccines under EUA.Results and Conclusion The methods and policies for EUA and risk control of Pfizer-BioNTech vaccine were made clear and we could provide a reference for the pharmacovigilance action after the COVID-19 vaccines were put on the market in China.In the case of EUA,it is necessary to analyze the existing clinical safety data.Based on this,the risk control process should be confirmed at the time of formal marketing approval and after listing.Finally,the risk control should be adjusted at any time.

关 键 词：COVID-19 vaccine emergency use authorization surveillance 

分 类 号：R95[医药卫生—药学]