Real-Time Pharmacovigilance: Transforming Population-Based Monitoring of Post-Approval Vaccine Safety Through Rapid Cycle Analysis (RCA)-A Review of the Published Literature.

ABSTRACT: Background/Objectives: 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. Methods: Embase and Medline were searched on 8 August 2024 to identify post-approval non-interventional vaccin

SUBMITTER: Gandhi S 

PROVIDER: S-EPMC11769534 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature