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

Author

Listed:
  • 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
    Otsuka Europe Development and Commercialisation Ltd)

  • Katsiaryna Holl

    (Health Economics Department, GSK Vaccines)

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.

Suggested Citation

  • Edouard Ledent & Alfons Lieftucht & Hubert Buyse & Keiji Sugiyama & Michael Mckenna & Katsiaryna Holl, 2016. "Post-Marketing Benefit–Risk Assessment of Rotavirus Vaccination in Japan: A Simulation and Modelling Analysis," Drug Safety, Springer, vol. 39(3), pages 219-230, March.
    • Handle: RePEc:spr:drugsa:v:39:y:2016:i:3:d:10.1007_s40264-015-0376-7
    DOI: 10.1007/s40264-015-0376-7
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    Cited by:

    1. Tina Singh & Frédérique Delannois & François Haguinet & Lifeter Yenwo Molo, 2022. "Review of Over 15 Years Postmarketing Safety Surveillance Spontaneous Data for the Human Rotavirus Vaccine (Rotarix) on Intussusception," Drug Safety, Springer, vol. 45(2), pages 155-168, February.
    2. Kaatje Bollaerts & Tom Smedt & Katherine Donegan & Lina Titievsky & Vincent Bauchau, 2018. "Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project," Drug Safety, Springer, vol. 41(8), pages 775-786, August.
    3. Wang, Linqiang & Feng, Xiuhuan & Zang, Luning, 2024. "Does risk perception influence individual investors' crowdfunding investment decision-making behavior in the metaverse tourism?," Finance Research Letters, Elsevier, vol. 62(PA).

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