Spontaneous reporting of adverse events following immunisation (AEFI) increased significantly compared to pre-COVID-19 vaccine rollout. A total number of AEFIs reported between 17 May 2021 and 30 April 2022 (SAHPRA microsite) was 5893, this represent a reporting rate of 0.0172% of total number of COVID-19 vaccine doses administered for the same time period. The most frequently reported AEFIs were in line with the available product information. No safety concerns were raised based causality assessment outcomes conducted on severe and serious AEFI reported. Vaccine safety surveillance and monitoring trends of reported AEFI are vital measures to ensure that the benefits of immunisation are maintained in the interest of public health. Transparent communication with the public is important to maintain public confidence in vaccines and prevent all AEFI being misinterpreted as caused by the vaccine. The department in collaboration with SAHPRA, provide information on the process of AEFI reporting, investigation and causality assessment on the SAHPRA microsite. The AEFI reported should be investigated and causality assessed to maintain high levels of vaccine confidence in the immunisation programme.
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