Gandhi Sampada, Iannacone Michelle R, Leapley Andrea, Wang Li, Mtenga Mwedusasa, Younus Muhammad, Wu Joanne
Safety Surveillance Research, Worldwide Medical and Safety, Pfizer, Inc., New York, NY 10001-2192, USA.
Pharmaceuticals (Basel). 2025 Jan 10;18(1):80. doi: 10.3390/ph18010080.
: Rapid cycle analysis (RCA) is an established and efficient methodology that has been traditionally utilized by United States health authorities to monitor post-approval vaccine safety. Initially developed in the Vaccine Safety Datalink (VSD) in early 2000s, RCA has evolved into a valuable approach for timely post-approval signal detection. Due to the availability of additional near real-time data sources and enhanced analytic approaches, the use of RCA has expanded. This narrative review provides an in-depth assessment of studies that utilized RCA for safety surveillance to detect and evaluate safety signals in post-approval vaccine monitoring. : Embase and Medline were searched on 8 August 2024 to identify post-approval non-interventional vaccine safety studies using RCA or other near real-time surveillance methods published from 1 January 2018 to 31 July 2024. Data on study characteristics (e.g., study population, data source, outcomes) and RCA methodological characteristics (e.g., type of comparator, sequential testing method, confounding control method) were extracted from the eligible RCA studies. : Of 1128 articles screened, 18 RCA vaccine safety studies were included, of which 17 (94.4%) were conducted in the United States (US). Twelve (67%) aimed at signal detection and six (33%) conducted further signal evaluation. Over 60% examined COVID-19 vaccine safety, with half using VSD. Over 80% conducted the RCA weekly or monthly and about 78% of the studies used a database-specific historical comparator group. : This review indicates that most of the published articles on the application of the RCA methodology in vaccine safety studies are based on research conducted in the US. With increasing availability of near real-time data sources and advanced analytic methods capabilities, RCA is expected to be more widely deployed as an active surveillance tool to complement traditional pharmacovigilance. Future studies should explore the extension of vaccine RCA methodology for non-vaccine medicinal products.
快速循环分析（RCA）是一种既定且高效的方法，美国卫生当局传统上一直使用该方法来监测疫苗批准后的安全性。RCA最初于21世纪初在疫苗安全数据链（VSD）中开发，现已发展成为一种用于及时进行批准后信号检测的重要方法。由于有更多近乎实时的数据源以及增强的分析方法，RCA的应用范围得以扩大。本叙述性综述对利用RCA进行安全性监测以在疫苗批准后监测中检测和评估安全信号的研究进行了深入评估。2024年8月8日检索了Embase和Medline，以识别2018年1月1日至2024年7月31日发表的使用RCA或其他近乎实时监测方法的批准后非干预性疫苗安全性研究。从符合条件的RCA研究中提取了有关研究特征（如研究人群、数据源、结局）和RCA方法学特征（如比较器类型、序贯检验方法、混杂控制方法）的数据。在筛选的1128篇文章中，纳入了18项RCA疫苗安全性研究，其中17项（94.4%）在美国进行。12项（67%）旨在进行信号检测，6项（33%）进行了进一步的信号评估。超过60%的研究检查了新冠疫苗的安全性，其中一半使用了VSD。超过80%的研究每周或每月进行一次RCA，约78%的研究使用特定数据库的历史比较组。本综述表明，关于RCA方法在疫苗安全性研究中应用的大多数已发表文章是基于在美国进行的研究。随着近乎实时数据源和先进分析方法能力的日益增加，预计RCA将作为一种主动监测工具得到更广泛的应用，以补充传统的药物警戒。未来的研究应探索将疫苗RCA方法扩展到非疫苗药品。
