The 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. Read more about development of the protocol template, the cohort event monitoring (CEM) study design, and how it can identify previously unrecognised and unsuspected adverse reactions to the vaccine. The CEM protocol was commissioned by World Health Organization (WHO), coordinated by Dr. Christine Guillard with the support of Dr. Noha Iessa, in the Pharmacovigilance (PVG) team, within the Regulation and Prequalification department at WHO Headquarters.
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