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 ...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.展开更多
Currently,people all over the world have been affected by coronavirus disease 2019(COVID-19).Fighting against COVID-19 is the top priority for all the countries and nations.The development of a safe and effective COVI...Currently,people all over the world have been affected by coronavirus disease 2019(COVID-19).Fighting against COVID-19 is the top priority for all the countries and nations.The development of a safe and effective COVID-19 vaccine is considered the optimal way of ending the pandemic.Three hundred and 44 vaccines were in development,with 149 undergoing clinical research and 35 authorized for emergency use as to March 15 of 2022.Many studies have shown the effective role of COVID-19 vaccines in preventing SARS-CoV-2 infections as well as serious and fatal COVID-19 cases.However,tough challenges have arisen regarding COVID-19 vaccines,including long-term immunity,emerging COVID-19 variants,and vaccine inequalities.A systematic review was performed of recent COVID-19 vaccine studies,with a focus on vaccine type,efficacy and effectiveness,and protection against SARS-CoV-2 variants,breakthrough infections,safety,deployment and vaccine strategies used in the real-world.Ultimately,there is a need to establish a unified evaluation standard of vaccine effectiveness,monitor vaccine safety and effectiveness,along with the virological characteristics of SARS-CoV-2 variants;and determine the most useful booster schedule.These aspects must be coordinated to ensure timely responses to beneficial or detrimental situations.In the future,global efforts should be directed toward effective and immediate vaccine allocations,improving vaccine coverage,SARS-CoV-2 new variants tracking,and vaccine booster development.展开更多
文摘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.
基金This study was done according to the principles and guidelines of the Declaration of Helsinki,and was approved by the Research Ethics Committee of the Zhejiang Provincial Center for Disease Control and Prevention(Grant No.2020-24).
文摘Currently,people all over the world have been affected by coronavirus disease 2019(COVID-19).Fighting against COVID-19 is the top priority for all the countries and nations.The development of a safe and effective COVID-19 vaccine is considered the optimal way of ending the pandemic.Three hundred and 44 vaccines were in development,with 149 undergoing clinical research and 35 authorized for emergency use as to March 15 of 2022.Many studies have shown the effective role of COVID-19 vaccines in preventing SARS-CoV-2 infections as well as serious and fatal COVID-19 cases.However,tough challenges have arisen regarding COVID-19 vaccines,including long-term immunity,emerging COVID-19 variants,and vaccine inequalities.A systematic review was performed of recent COVID-19 vaccine studies,with a focus on vaccine type,efficacy and effectiveness,and protection against SARS-CoV-2 variants,breakthrough infections,safety,deployment and vaccine strategies used in the real-world.Ultimately,there is a need to establish a unified evaluation standard of vaccine effectiveness,monitor vaccine safety and effectiveness,along with the virological characteristics of SARS-CoV-2 variants;and determine the most useful booster schedule.These aspects must be coordinated to ensure timely responses to beneficial or detrimental situations.In the future,global efforts should be directed toward effective and immediate vaccine allocations,improving vaccine coverage,SARS-CoV-2 new variants tracking,and vaccine booster development.
