Safety Surveillance of Pneumococcal Vaccine Using Three Algorithms: Disproportionality Methods, Empirical Bayes Geometric Mean, and Tree-Based Scan Statistic.

ABSTRACT: Introduction: Diverse algorithms for signal detection exist. However, inconsistent results are often encountered among the algorithms due to different levels of specificity used in defining the adverse events (AEs) and signal threshold. We aimed to explore potential safety signals for two pneumococcal vaccines in a spontaneous reporting database and compare the results and performances among the algorithms. Methods: Safety surveillance was conducted using the Korea national spontaneous reporting database from 1988 to 2017. Safety signals for pneumococcal vaccine and its subtypes were detected using the following the algorithms: disproportionality methods comprising of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC); empirical Bay

SUBMITTER: Lee H 

PROVIDER: S-EPMC7349998 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature