Scoping review of near real-time surveillance of vaccine safety

doi:10.19803/j.1672-8629.20220619

Abstract

Abstract: Objective To review the characteristics, processes and mechanisms of current near real-time surveillance systems for vaccine afety worldwide, and to establish a standardized workflow. Methods The scoping review was used to evaluate, define, retrieve and screen information related to the near real-time surveillance systems of vaccine safety. The framework synthesis was applied to determine the analytical framework, coding and mapping information about characteristics of data, surveillance procedures and operational mechanisms before the core elements of near real-time surveillance were summarized and a standardized workflow was established. Results Fifty pieces of literature were included in this study. A total of six systems or organizations worldwide were identified to routinely conduct near real-time surveillance. The “automatic linkage and distributed computing” model could effectively improve monitoring efficiency and meet the higher requirements of timeliness. The standardized workflow for near real-time surveillance was summarized as follows: ①Automatic data extraction by computer programs; ②Data standardization using individual-level CDM; ③Regular data submission using aggregate-level CDM; ④Step-by-step analyses involving signal description, detection, and validation. Conclusion Near real-time surveillance has become automatic and regular in several active surveillance systems worldwide. It is believed that this review would serve as a framework for future vaccine-safety endeavors in China to establish a valuable, population-based near real-time surveillance system.

Key words: vaccine, safety, post-marketing, active surveillance, near real-time surveillance, scoping review

CLC Number:

R978
R954

SUN Yixin, LIU Zhike, ZHAN Siyan. Scoping review of near real-time surveillance of vaccine safety[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 61-67.

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