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

Abstract

IntroductionRotarix™, 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.ObjectiveIn this paper, we compare the benefit and risk of vaccination side-by-side in a benefit–risk analysis.MethodsThe 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 (Statistics Bureau, Ministry of Internal Affairs and Communications), and market survey data.ResultsFor a birth cohort of 1 million vaccinated Japanese children followed for 5 years, the benefit–risk analysis suggested that the vaccine would prevent ~17,900 hospitalizations and ~6.3 deaths associated with RVGE. At the same time, vaccination would be associated with about ~50 intussusception hospitalizations and ~0.017 intussusception deaths. Therefore, for every intussusception hospitalization caused by vaccination and for one intussusception-associated death, 350 (95 % CI 69–2510) RVGE-associated hospitalizations and 366 (95 % CI 59–3271) RVGE-associated deaths are prevented, respectively, by vaccination.ConclusionsThe benefit–risk balance for Rotarix™ is favorable in Japan. From a public health perspective, the benefits in terms of prevented RVGE hospitalizations and deaths for the vaccinated population far exceed the estimated risks due to intussusception.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-015-0376-7) contains supplementary material, which is available to authorized users.