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

摘要: Rotarix™, GSK’s live attenuated rotavirus vaccine, was introduced in Japan 2011. A recent trend reduction of gastroenteritis (RVGE) due to this vaccine described. However, an observed/expected analysis showed a temporal association with intussusception within 7 days post dose 1. In paper, we compare the benefit and risk vaccination side-by-side benefit–risk analysis. The number vaccine-preventable RVGE-associated hospitalizations deaths (benefit) intussusception-associated (risk) following two doses Rotarix™ compared using simulations. Source data included peer-reviewed clinical epidemiological publications, Japanese governmental statistics (Statistics Bureau, Ministry Internal Affairs Communications), market survey data. For birth cohort 1 million vaccinated children followed for 5 years, suggested that would prevent ~17,900 ~6.3 associated RVGE. At same time, be about ~50 ~0.017 deaths. Therefore, every hospitalization caused by one death, 350 (95 % CI 69–2510) 366 59–3271) are prevented, respectively, vaccination. balance is favorable Japan. From public health perspective, benefits terms prevented RVGE population far exceed estimated risks intussusception.