Real-Time Surveillance to Assess Risk of Intussusception and Other Adverse Events After Pentavalent, Bovine-Derived Rotavirus Vaccine

Abstract

This study illustrates the feasibility of rapid vaccine safety assessment and provides additional evidence that RotaTeq is not associated with an increased risk of intussusception.

Risk of Intussusception After Rotavirus Vaccination

“…The German Standing Committee on Vaccination (STIKO, Ständige Impfkommission) published its recommendation that infants should receive RV vaccination in August 2013. Based on data from observational studies available at that time, the risk was estimated to be 1 to 2 additional intussusceptions per 100 000 vaccinated infants, irrespective of which vaccine was used (13)(14)(15)(16)(17)(18)(19)(20)(21)(22). STIKO states explicitly that the vaccination is associated with a slightly increased risk of intussusception during the first week after the first dose of vaccine.…”

A rare human infection of Raoultella ornithinolytica in a diabetic foot lesion

“…The fluid culture isolated from the cyst was positive for R ornithinolytica 4. The third reported case was of R ornithinolytica bacteremia in an infant with visceral heterotaxy 5. Only this case showed marked skin flushing, which was possibly related to a histamine reaction.…”

Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini‐Sentinel pilot

“…The group sequential likelihood ratio test (LRT) approach is a method that has been used in the Vaccine Safety Data Link project to monitor vaccine safety for a single time vaccine exposure. 3,6,7,14 The approach uses exposure matching with a fixed matching ratio (1:M) to control for confounding and then computes a LRT statistic. The most commonly used method is the Binomial maxSPRT, 14 which assumes continuous monitoring (i.e., after each matched set of exposed and unexposed individuals come into the dataset, the test statistic is compared with the monitoring boundary).…”

“…3 Exp cum is the total cumulative exposure time observed at and before look t. 4 Exp cum,D = A is the total cumulative exposure time observed at and before look t for those on drug A. 5 RR AtoB is the adjusted relative risk (RR) comparing drug A to drug B at each look adjusting for site, age, sex, and BMI category.…”

“…There have been several examples of signal refinement studies published, but this is still a relatively new area. [3][4][5][6][7] Statistical methods used to address hypotheses within postmarket safety evaluation designs must be able to detect both rare and common adverse events, control for confounding, and maintain the overall type I error across multiple tests. This manuscript describes the current state of statistical methods developed to conduct sequential analysis of prospective cohort data for medical product safety.…”