Covid-19 vaccines: safety surveillance manual - Establishing surveillance systems in countries

Overview

The role of vaccine safety surveillance during COVID-19 vaccine introduction is to facilitate the early detection, investigation and analysis of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) to ensure an appropriate and rapid response. This will decrease the negative impact of these events on the health of individuals and the immunization programmes and maintain the confidence of health care workers (HCWs) and the general population. To achieve this, the global goals of COVID-19 vaccine safety surveillance are to:

• detect serious AEFIs/AESIs rapidly in order to provide timely data that can be shared with relevant stakeholders for action;

• generate data to characterize the safety profile of the COVID-19 vaccines in use;

• help to monitor the acceptable benefit-risk ratio throughout the COVID-19 vaccine life-cycle;

• identify, investigate, assess and validate safety signals and recommend appropriate public health or other interventions; and

• maintain public and stakeholder confidence in vaccines and immunization by ensuring high quality safety surveillance.

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