Ab Rahman Norazida, Lim Ming Tsuey, Lee Fei Yee, Ong Su Miin, Peariasamy Kalaiarasu M, Sivasampu Sheamini
Institute for Clinical Research, National Institutes of Health, Ministry of Health, Selangor, Malaysia.
Clinical Research Centre, Selayang Hospital, Ministry of Health, Selangor, Malaysia.
Front Pharmacol. 2022 Jul 13;13:834940. doi: 10.3389/fphar.2022.834940. eCollection 2022.
In response to Coronavirus disease 2019 (COVID-19) global pandemic, various COVID-19 vaccines were rapidly administered under emergency use authorization. Rare outcomes associated with COVID-19 vaccines might be less likely to be captured in clinical trials, leading to a knowledge gap in real-world vaccine safety. In contrast with high-income countries, many low-to-middle income countries have limited capacity to conduct active surveillance, owing to the absence of large and fully-integrated health information databases. This paper describes the study protocol, which aims to investigate risk of prespecified adverse events of special interests following COVID-19 vaccination in a partially integrated health information system with non-shareable electronic health records. The SAFECOVAC study is a longitudinal, observational retrospective study of active safety surveillance using case-based monitoring approach. This involves linkage of several administrative databases and hospitalization data monitoring to identify adverse events of special interests following administration of COVID-19 vaccines in Malaysia. The source population comprises of all individuals who received at least one dose of COVID-19 vaccine. Self-controlled design and vaccinated case-coverage design will be employed to assess risk of adverse events of special interests and determine the association with vaccine exposure. Data on vaccination records will be obtained from the national COVID-19 vaccination register to identify the vaccination platforms, doses and the timing of vaccinations. The outcome of this study is hospitalization for the adverse events of special interests between March 2021 and June 2022. The outcomes will be obtained through linkage with hospital admission database and national pharmacovigilance database. Findings will provide analysis of real-world data which can inform deliberations by government and public health decision makers relative to the refinement of COVID-19 vaccination recommendations.
为应对2019冠状病毒病（COVID-19）全球大流行，多种COVID-19疫苗在紧急使用授权下迅速投入使用。与COVID-19疫苗相关的罕见结果在临床试验中可能较难被捕捉到，这导致了实际疫苗安全性方面的知识空白。与高收入国家不同，许多中低收入国家由于缺乏大型且完全整合的健康信息数据库，主动监测能力有限。本文描述了一项研究方案，旨在通过一个具有不可共享电子健康记录的部分整合健康信息系统，调查COVID-19疫苗接种后特定预设不良事件的风险。SAFECOVAC研究是一项采用基于病例监测方法的主动安全监测的纵向观察性回顾研究。这涉及将多个行政数据库与住院数据监测相链接，以识别马来西亚COVID-19疫苗接种后特定预设不良事件。源人群包括所有接种过至少一剂COVID-19疫苗的个体。将采用自我对照设计和接种病例覆盖设计来评估特定预设不良事件的风险，并确定其与疫苗暴露的关联。疫苗接种记录数据将从国家COVID-19疫苗接种登记处获取，以确定疫苗接种平台、剂量和接种时间。本研究的结果是2021年3月至2022年6月期间因特定预设不良事件而住院的情况。结果将通过与医院入院数据库和国家药物警戒数据库相链接获得。研究结果将提供实际数据的分析，可为政府和公共卫生决策者在完善COVID-19疫苗接种建议方面的审议提供参考。
