Post-Marketing Benefit-Risk Assessment of Rotavirus Vaccination in Japan: A Simulation and Modelling Analysis.

ABSTRACT:

Introduction

Rotarix™, GSK's live attenuated rotavirus vaccine, was introduced in Japan in 2011. A recent trend in reduction of rotavirus gastroenteritis (RVGE) due to this vaccine was described. However, an observed/expected analysis showed a temporal association with intussusception within 7 days post dose 1.

Objective

In this paper, we compare the benefit and risk of vaccination side-by-side in a benefit-risk analysis.

Methods

The number of vaccine-preventable RVGE-associated hospitalizations and deaths (benefit) and intussusception-associated hospitalizations and deaths (risk) following two doses of Rotarix™ in Japan was compared using simulations. Source data included peer-reviewed clinical and epidemiological publications, Japanese governmental statistics (Stati

SUBMITTER: Ledent E 

PROVIDER: S-EPMC4749653 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature