Section of Clinical Epidemiology, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
Department of Health Care Administration and Management, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Vaccine. 2022 Oct 6;40(42):6179-6186. doi: 10.1016/j.vaccine.2022.08.069. Epub 2022 Sep 9.
Japan currently lacks a data platform that can support quantitative assessments of the causal relationships between vaccines and adverse events. This study describes the development and application of the Vaccine Effectiveness, Networking, and Universal Safety (VENUS) Study to facilitate such assessments.
A database was created by linking public insurance enrollees' claims data with vaccination records acquired from participating municipalities. To provide an overview of the study data, we produced descriptive statistics of sex, age, and vaccinations. We also conducted a pilot study using the database to assess influenza vaccine safety during the 2018/2019 season among older persons (≥65 years) residing in a single municipality.
Our database was created using data from approximately 1.12 million individuals in 7 municipalities between 2013 and 2020. The data during fiscal year 2018 included 853,016 individuals (male: 363,079, female: 489,937) with a median age of 70 years (interquartile range: 52-79). We obtained information on 17 vaccine types, including the pneumococcal vaccine and influenza vaccine. In the pilot study, we analyzed 48,723 vaccinated persons matched with 48,723 unvaccinated persons. The only adverse event that occurred in both groups was Bell's palsy, which had an adjusted incidence rate ratio of 1.21 (95 % confidence interval: 0.48-3.07).
The VENUS Study is Japan's first healthcare data platform that enables comparative assessments of vaccinated and unvaccinated persons in large samples covering all age groups. Efforts are underway to increase the number of participating municipalities and to generate evidence on vaccine effectiveness and safety.
日本目前缺乏一个能够支持定量评估疫苗与不良事件之间因果关系的数据平台。本研究描述了 Vaccine Effectiveness, Networking, and Universal Safety（VENUS）研究的开发和应用，以促进此类评估。
通过将公共保险参保者的索赔数据与来自参与市町村的接种记录相链接，创建了一个数据库。为了提供研究数据的概述，我们对性别、年龄和接种情况进行了描述性统计。我们还使用该数据库进行了一项试点研究，评估了 2018/2019 年在一个市町村居住的老年人（≥65 岁）中流感疫苗的安全性。
我们的数据库是使用 2013 年至 2020 年期间 7 个市町村的约 112 万人的数据创建的。2018 财年的数据包括 853016 人（男性：363079 人，女性：489937 人），中位年龄为 70 岁（四分位距：52-79）。我们获得了 17 种疫苗类型的信息，包括肺炎球菌疫苗和流感疫苗。在试点研究中，我们分析了 48723 名接种疫苗的人和 48723 名未接种疫苗的人。两组中唯一发生的不良事件是贝尔麻痹，其调整后的发病率比为 1.21（95%置信区间：0.48-3.07）。
VENUS 研究是日本首个医疗保健数据平台，能够在涵盖所有年龄组的大样本中对接种疫苗和未接种疫苗的人进行比较评估。正在努力增加参与市町村的数量，并生成疫苗有效性和安全性的证据。
