Progress in applications of self-controlled designs in association study of vaccine safety

doi:10.19803/j.1672-8629.20220618

Abstract

Abstract: Active surveillance of vaccine safety is a crucial and essential part of the whole evidence chain of vaccine safety, especially for the surveillance of serious adverse reactions following immunization. In recent years, electronic health care databases have been facilitating the active surveillance of vaccine safety and association study. Globally, more than a dozen countries have performed active surveillance of vaccine safety using the electronic health records, medical claim, electronic medical records. The surveillance designs involved cohort study, case control study, and self-controlled study. Self-controlled designs, such as self-controlled case series study and self-controlled risk interval study, have been increasingly used in vaccine safety monitoring outside China. The review outlines the applications of and progress in self-controlled studies in association study of vaccine safety in the hope of contributing to post-marketing surveillance of vaccine risks in the real world.

Key words: vaccine, safety, self-controlled, active surveillance, adverse reactions

CLC Number:

R954
R994.1

LIU Zhike, ZHAN Siyan. Progress in applications of self-controlled designs in association study of vaccine safety[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 74-78.

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