Protocol template to be used as template for observational study protocols for sentinel surveillance of adverse events of special interest (AESIs) after vaccination with COVID-19 vaccines.

Overview

WHO has published the COVID-19 vaccines: safety surveillance manual to guide the processes for collecting, analysing and sharing safety data and information on COVID-19 vaccines within and across countries. To accompany this manual and facilitate the conduct of active safety surveillance studies using harmonized tools and methods, a protocol template for hospital case-based sentinel surveillance studies is proposed. Sentinel surveillance is an active safety surveillance study design that can be used for signal detection and evaluation. The present template is for sentinel surveillance studies of COVID-19 vaccines for the purpose of safety signal detection. Sentinel surveillance is based on an active safety surveillance study design that can be used for signal detection and evaluation. The present protocol template describes study designs for hospital case-based monitoring of pre-defined adverse events of special interest (AESIs) following COVID-19 vaccination in all age groups.