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As COVID-19 vaccines are being rolled out globally, there is an increasing use of different methods for the study of the safety and comparative effectiveness of vaccines. Research has been conducted on the effectiveness of some vaccines using cohort methods, and signals have been identified by different ...

As COVID-19 vaccines are being rolled out globally, there is an increasing use of different methods for the study of the safety and comparative effectiveness of vaccines. Research has been conducted on the effectiveness of some vaccines using cohort methods, and signals have been identified by different regulators using historical comparison of rates. Protocols have been published and registered using various methods, and will report in due course.

There is a paucity of literature on the performance of the different methods available for the study of vaccine safety and effectiveness. There is therefore an urgent need for robust literature on this topic.

As many protocols and studies are ongoing, there is a need to compile existing knowledge on the bias and precision of existing methods for vaccine safety surveillance. The goal of this research topic will be to:
• Review and present up-to-date evidence on the existing methods for vaccine safety and effectiveness research
• Compile any upcoming results from methodological studies on the performance and validity of these methods
• Summarize both previous and new knowledge on the best methods for the monitoring of vaccine safety, and the study of their effectiveness

Scope and Type of Manuscripts:
• Systematic reviews of the literature on methods for vaccine safety and effectiveness research
• Simulation studies on the performance of methods used for vaccine safety and effectiveness research
• Methodological studies on the performance of methods for vaccine safety and effectiveness research using real world data
• Real world evidence (RWE) studies on the effectiveness/comparative effectiveness of COVID19 vaccines
• RWE studies on the safety/comparative safety of COVID19 vaccines

Conflict of Interests Statement:
The Topic Editor Daniel Prieto-Alhambra's research team/department has received research grants from Amgen, Novartis, and UCB Biopharma SRL, and departmental fees/payment for consultancy/speaker services to Amgen, Astellas, Astra Zeneca and UCB Biopharma SRL

Keywords: Vaccine safety, vaccine effectivness, real world evidence studies, COVID-19, safety surveillance


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