23 Jun Background Incidence Rates of Selected Vaccine Adverse Events of Special Interest
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Background Incidence Rates of Selected Vaccine Adverse Events of Special Interest
OS0018
Overview
Background
- The COVID-19 pandemic highlighted the need for timely detection of emerging safety signals for new vaccines and continuous lifecycle monitoring for established vaccines.
- Background incident rates of adverse events of special interest (AESIs) can facilitate the identification of vaccine safety signals using observed-to-expected analyses, by comparing the number of events observed after vaccination to the number expected in the absence of vaccination
- Such analyses were conducted globally in response to safety concerns arising during the COVID-19 vaccine rollout. In Canada, evidence on background incidence rates of AESIs is currently limited to the provinces of British Columbia and Ontario, highlighting the need for national data.
Objective
- As part of a collaboration with the International Coalition of Medicine Regulatory Authorities (ICMRA), we will replicate a study conducted by DARWIN EU (EUPAS1000000254).
- The main objective is to estimate background incidence rates of selected vaccine AESIs in Canada.