[Scoping review of active surveillance systems for vaccine safety world-wide]

Objective: To identify post-marketing active surveillance systems for vaccine safety around the world and understand their features and mechanisms, in order to provide guidance for vaccine administration activities in China. Methods: Following the steps of scoping review, literature about active surveillance system for vaccine safety and published by 30 June 2018 were identified by searching electronic databases, including PubMed, Scopus, and Cochrane Library. Grey literature were also sought by exploring relevant websites. Identified literature were screened according to eligibility criteria, and informative data from included literature were then charted. Framework Synthesis and Thematic Analysis were performed to integrate the charted data. Results: 97 pieces of literature were included for review, and 11 active surveillance systems for vaccine safety were identified, mostly located in developed countries. These systems were constructed by 3 types of organizations: administration departments, academic or research institutions, and health care providers. Their data sources included immunization registries, electronic medical records, claims data, case reports of adverse events following immunization electronic questionnaires, and epidemiologic study data. According to their operation procedures, these systems were grouped into 4 modes of active surveillance: Data Linkage, Investigator Network, Automatic Follow-up System, Studies Consortium. Conclusion: Practice of active surveillance for vaccine safety greatly varies across countries, with different conditions and advantages. It is suggested that developing countries should choose suitable mode of active surveillance considering their local situations.