Protocol template to be used as template for observational study protocols for cohort event monitoring (CEM) for safety signal detection 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 cohort event monitoring (CEM) studies has been developed. The present template protocol is for CEM studies of COVID-19 vaccines for the purpose of safety signal detection. The protocol synopsis was developed under the guidance of a scientific committee including former and current Global Advisory Committee on Vaccine Safety (GACVS) committee members, and reviewed by the GACVS during its meeting held on 1-3 December 2020.