Abstract

The World Health Organization recommends inclusion of rotavirus vaccines in national immunization programs (NIPs) worldwide. Nordic countries are usually considered comparable in terms of demographics and health-care services and have comparable rotavirus disease burden. Nevertheless, the countries have reached different decisions regarding rotavirus vaccine: Norway and Finland have already introduced rotavirus vaccines into their NIPs and Sweden is currently changing its recommendation and vaccines will now be introduced on a national scale while Denmark has decided against it. This study focuses on the selection and interpretation of medical and epidemiological evidence used during the decision-making processes in Sweden, Norway, Finland, and Denmark. The so-called “severity criteria” is identified as one of the main reasons for the different policy decisions reached across the Nordic countries.

Highlights

  • Two oral, live, attenuated rotavirus vaccines, RotarixTM and RotaTeqTM, are used internationally; and both vaccines are considered highly effective in preventing severe gastrointestinal disease [1]

  • Rotavirus vaccines have been available for pur­chase at private vaccination centers for several years prior to this decision, and one of the vaccines available on the market is sub­sidized by the Dental and Pharmaceutical Benefits Agency, TLV

  • Decisions regarding inclusion of new vaccines in the Swedish national immunization programs (NIPs) are taken by the Swedish government [14]

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Summary

Introduction

Live, attenuated rotavirus vaccines, RotarixTM (derived from a human G1P[8] rotavirus strain) and RotaTeqTM (a reassorted bovine–human rotavirus), are used internationally; and both vaccines are considered highly effective in preventing severe gastrointestinal disease [1]. There are no uniform guidelines for decision-making processes or policies for introduction of new vaccines, individual countries usually consider disease burden, health care and vaccine-related costs and safety and effectiveness of vaccine candidates [4]. Surveillance and research studies on rotavirus hospitalizations and deaths [5] have demonstrated that the incidence of rotavirus does not vary much across countries worldwide, but the risk of dying from rotavirus disease is much higher in low-income countries, and there is general agreement on the rationale for Vaccine Introduction: Decision-Taking Processes and Policies the need for prevention of rotavirus disease in such settings [6]. In high-income countries, where rotavirus-associated mortality is generally low, there has been more debate on the need for and cost-effectiveness (CE) of the vaccines [7]. The Nordic countries are usually considered similar and com­ parable in terms of demographics, disease burden and healthcare systems with tax-based funding, publicly owned and operated hospitals, universal residence-based access, and comprehensive coverage [8]

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