Establishing an Active Vaccine Safety Surveillance System Using Large Scale Databases in Korea: Lessons and Scalable Insights for Global Application

Abstract

Vaccines are highly effective, but rare or delayed adverse events following immunization (AEFIs) require post-licensure surveillance beyond clinical trials. Korea lacks a comprehensive, active, database-based framework, yet key assets exist: nationwide claims databases (National Health Insurance Service/Health Insurance Review and Assessment Service), the national immunization registry (Korea Disease Control and Prevention Agency's Immunization Registry Information System) for National Immunization Program (NIP) and non-NIP vaccines, and increasingly standardized hospital electronic health records. We propose a federated, code to data architecture with data linkages between these data. Implementation should adopt a common data model (CDM), standardized case definitions, latency accounting, and transparent public reporting under strong privacy governance. Major challenges include multi step administrative approvals for data linkage, incomplete capture of adult non-NIP vaccinations, heterogeneous hospital data structures, and strict data protection constraints. Strategic priorities are to streamline statutory and administrative processes for public health use, mandate or enable claims-based capture of adult vaccinations, enhance CDM based interoperability, and develop secure hubs for aggregated outputs. With these measures, Korea will be well positioned to establish a scalable active surveillance system capable of detecting rare AEFIs, supporting transparent and evidence-based communication, and ensuring equitable injury compensation grounded in domestic data.

Keywords: Adverse Effects; Database; Korea; Safety; Surveillance; Vaccines.

Fig. 1. Overview of data integration of each agency and individual health care centers. NHIS not only provides the claim data of national health insurance but also serves as a data integration agency, enabling analysis of combined data.

AEFI = adverse events following immunization, CDM = common data model, CDW = clinical data warehouse, KDCA = Korea Disease Control and Prevention Agency, NIP = National Immunization Program, NHIS = National Health Insurance Service.

Fig. 2. Data integration request and process for the combined analysis of immunization data and individual vaccine adverse event data. The data provider must obtain approval from IRB and DRB for data provision and pseudonymization. Then the data provider should undergo the data integration review at the data custodian. When approved, the data provider creates integration keys and provides them to the data custodian. After payment of the integration fee and approval of data exportation review, analysis can be performed on the analysis server.

KDCA = Korean Disease Control and Prevention Agency, NHIS = National Health Insurance Service, IRB = Institutional Review Board, DRB = Institutional Healthcare Data Review Board, KISA = Korea Internet & Security Agency.