Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception.

ABSTRACT:

Introduction

Rotavirus (RV) is the most common cause of acute gastroenteritis in children <5 years of age worldwide, and vaccination reduces the disease burden. Evidence from postmarketing surveillance studies suggested an increased risk of intussusception (IS) in infants post-RV vaccination. An overall positive benefit-risk balance for the human RV vaccine (HRV) Rotarix (GlaxoSmithKline [GSK], Belgium) has been established and recent findings indicate an indirect effect of reduced IS over the long term.

Objective

The aim of this study was to discuss spontaneous data from the GSK worldwide safety database on IS post-Rotarix administration.

Methods

The database was reviewed for all spontaneous IS cases from 2004 to 2020. Additionally, an observed versus expected (O/E)

SUBMITTER: Singh T 

PROVIDER: S-EPMC8894299 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature