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

Edouard Ledent (), Alfons Lieftucht, Hubert Buyse, Keiji Sugiyama, Michael Mckenna and Katsiaryna Holl
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Edouard Ledent: Clinical Statistics, GSK Vaccines
Alfons Lieftucht: Chief Medical Office, GSK UK Ltd
Hubert Buyse: Safety Department, GSK Vaccines
Keiji Sugiyama: Japan Vaccine Co., Ltd.
Michael Mckenna: Safety Department, GSK Vaccines
Katsiaryna Holl: Health Economics Department, GSK Vaccines

Drug Safety, 2016, vol. 39, issue 3, No 4, 219-230

Abstract: 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 (Statistics Bureau, Ministry of Internal Affairs and Communications), and market survey data. Results For 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. Conclusions The 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.

Date: 2016
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DOI: 10.1007/s40264-015-0376-7

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