In the context of COVID-19 vaccine introduction, conventional vaccine safety surveillance systems will need to rapidly adapt to newer techniques of surveillance and ensure that post-vaccination safety and exposure information are collected and processed rapidly and responded to in near real time to ensure that the safety of the public is not put at risk. Preparedness to address safety concerns rapidly is essential to counter real or perceived safety concerns particularly in the context of addressing adverse events following immunization (AEFIs) and adverse events of special interest (AESIs). For AEFIs, any event following immunization that is notified is reported and processed as outlined in the module on AEFIs; however prespecified AESI should be identified through an active process and then reported, investigated and analyzed to identify signals.
Pharmacovigilance (PVG), Regulation and Prequalification (RPQ)
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Reference numbers
WHO Reference Number: WHO/MHP/RPQ/PVG/2021.5
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