Development of a COVID-19 vaccine effectiveness and safety assessment system in Japan: The VENUS study

• Published in: Vaccine 2023-05, Vol.41 (23), p.3556-3563
• Main Authors: Fukuda, Haruhisa, Maeda, Megumi, Murata, Fumiko
• Format: Article
• Language: English
• Subjects: Algorithms; Clinical trials; Comparative analysis; Computer Systems; Coronaviruses; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; Data collection; Effectiveness; Health care facilities; Health care policy; Health facilities; Humans; Immunization; Information sharing; Information systems; Insurance coverage; Japan - epidemiology; Municipal government; Municipalities; National health insurance; Pandemics; Polymerase chain reaction; Public health; Real-world data; Registration; Safety; Self employment; Surveillance; Vaccination; Vaccine Efficacy; Vaccines
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2023.03.059

•This is Japan’s first database that enables active COVID-19 vaccine surveillance.•The VENUS Study can provide a data platform to facilitate COVID-19 vaccine studies.•Japan’s database environment requires rebuilding to support active surveillance. There are currently no COVID-19 vaccine assessment systems in Japan that allow for the active surveillance of both vaccinated and unvaccinated persons. Herein, we describe the development of Japan’s first COVID-19 vaccine effectiveness and safety assessment system with active surveillance capabilities. The Vaccine Effectiveness, Networking, and Universal Safety (VENUS) Study was developed as a multi-source database that links four data types at the individual resident level: Basic Resident Register (base population information), Vaccination Record System (vaccination-related information), Health Center Real-time Information-sharing System on COVID-19 (HER-SYS; information on COVID-19 occurrence), and health care claims data (information on diagnoses, hospitalizations, diagnostic tests, and treatments). These data were obtained from four municipalities. Individual residents were linked across the data types using five matching algorithms based on names, birth dates, and sex; the data were anonymized after linkage. To ascertain the viability of the VENUS Study’s database for COVID-19 vaccine assessments, we examined the trends in COVID-19 vaccinations, COVID-19 cases, and polymerase chain reaction (PCR) test numbers. We also evaluated the linkage rates across the data types. Our multi-source database was able to monitor COVID-19 vaccinations, COVID-19 cases, and PCR test numbers throughout the pandemic. Using the five algorithms, the data linkage rates between the COVID-19 occurrence information in the HER-SYS and the Basic Resident Register ranged from 85·4% to 91·7%. If used judiciously with an understanding of each data source’s characteristics, the VENUS Study can provide a viable data platform that facilitates active surveillance and comparative analyses for population-based research on COVID-19 vaccine effectiveness and safety in Japan.