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Background rates of adverse events of special interest (AESI) for monitoring COVID-19 vaccines

Part I of the study is looking into background incidences of adverse events from 2010 to 2020, amongst different groups of the population. 

Study Purpose

The study aims to construct a clear background of the potential adverse events occurring after vaccination, the data will be categorised into both general and special patient groups (e.g.: pregnant women or children)

Study Content

The study will use a retrospective cohort design and include data from the period 2010 to 2020. Subpopulations such as pregnant women or children will be created. The study will look into databases provided by the Hospital Authority, focusing on instances that contain AESI, adverse events endorsed by WHO Global Advisory Committee on Vaccine Safety (GACVS), along with three additional adverse events. These adverse events may be related to currently marketed vaccines, which could potentially be associated with the COVID-19 vaccine. This study will generate background rates of AESI in Hong Kong over the period 2010 to 2019 (10 years), and in 2020 from the outbreak of the COVID-19 in Hong Kong to the latest date of data available before the start of the mass vaccine programme. By comparing the background incidence rates of an AESI with the rate following the vaccination programme, we can monitor the potential incremental risk of the vaccine.

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Background rates of adverse events of special interest (AESI) of COVID-19 vaccines subgroups for monitoring