Covid-19 vaccines: safety surveillance manual - Safety data management systems

Overview

WHO’s global manual on surveillance of adverse events following immunization (AEFIs)1 provides guidance on the purpose of data analysis at different levels. For example, who should analyse data, how it should be analysed and interpreted and its use for estimating relative and attributable risks. In the context of COVID-19 vaccine AEFI surveillance, the same principles and approaches should be applied, with some adaptation to allow for different vaccination strategies, vaccine target populations, types of vaccines and the surveillance systems available in different countries.

Guidance on vaccine safety surveillance systems and responding to AEFIs and adverse events of special interest (AESIs) to address the unique challenges from COVID-19 vaccine introduction is given in separate modules (AEFI and AESI modules). Once surveillance systems are operational, the efficiency and effectiveness of the system will be determined by the outputs and outcomes from the system. First, the raw data generated by the system needs to be collated, then transmitted, processed and interpreted and, finally, responded to systematically and scientifically. This module will provide guidance on how COVID-19 vaccine safety data should be processed and made actionable.