Criteria for vaccine introduction: results of a DELPHI discussion among international immunisation experts on a stepwise decision-making procedure
Based on a model of a stepwise approach for decision-making on vaccine introduction, this study aimed to reveal unpublished decision aids, to assess cut-off limits or thresholds for vaccine introduction that have already been used, and to discuss the comprehensiveness and feasibility of our suggested model.
Forty international immunisation experts were invited to a DELPHI discussion, 14 finally participated. Experts received a questionnaire and were asked for comments on other experts’ opinions and specification of their previously given answers in the second DELPHI round. We did not intend to develop a consensus document.
Though most of the DELPHI participants were not aware of decision aids other than the five that had been used for the development of our model, the international discussion revealed four additional national documents that define decision-making criteria. Except for one example with a cost-utility ratio, no defined thresholds or cut-off limits have been used in vaccine introduction decisions so far. The majority of experts believe that a stepwise approach could enhance the feasibility of decision aids. The experts agreed that the influence of each single criterion of our model should be at least “important” for decision-making. The most often mentioned possible negative consequence that could arise from a rigid stepwise procedure, was a delay of the vaccine introduction process.
The suggested stepwise procedure provides a systematic and evidence-based standardised way to support public health immunisation policy decisions. A framework could be a common starting point.
KeywordsImmunisation Vaccination Preventive health services
First of all the authors gratefully acknowledge the time and effort of the DELPHI participants, without whom this project would not have been possible. Furthermore we thank Claudia Wild, the head of our HTA institution, for idea input and guidance as well as our colleague Stefan Mathis for the technical support in the preparation of the word form documents and the data export.
Conflict of interest
The authors declare that they have no conflict of interest.
- Australian Government Department of Health and Ageing Pharmaceutical Benefits Advisory Committee (2008) Guidelines for preparing submissions to the pharmaceutical benefits advisory committee (version 4.3). Commonwealth of Australia. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacguidelines-index. Cited 4 June 2010
- Castillo-Solórzano C, Andrus J (2004) El desarrollo de nuevas vacunas: generación de información para la toma de decisions. Rev Panam Salud Públ 15(1):1–3Google Scholar
- González Alonso J, Pachón del Amo I, Anchuela OT, Heras CA, Peña-Rey Lorenzo I, García FS, et al (2004) Criterios para fundamentar la modificación de los programas de vacunas. Ministerio de sanidad y consumo- Subdirección general de promoción de la salud y epidemiología. http://www.msc.es/ciudadanos/proteccionSalud/vacunaciones/docs/criteriosVacunas.pdf. Cited 4 June 2010
- Hutt HJ (2008) How do we tackle the complex field of vaccinology in the twenty-first century? J Public Health 16(4): 245-246Google Scholar
- Lopalco PL (2010) Improving vaccination programmes in the European Union. J Public Health 16(4): 281-285Google Scholar
- Mansoor O, Shin S, Maher C, and the Immunization Focus of WPRO (2000) Assessing new vaccines for national immunization programmes: a framework to assist decision makers. World Health Organization Western Pacific Regional Office. http://whqlibdoc.who.int/hq/2000/9290611545.pdf. Cited 4 June 2010
- Stratton K, Durch J, Lawrence S, Editors Committee to Study Priorities for Vaccine Development Division of Health Promotion and Disease Prevention Institute of Medicine (2000) Vaccines for the 21st century: a tool for decisionmaking. National Academies Press, Washington, DCGoogle Scholar
- World Health Organization (2005) Expanded programme on immunization of the department of immunization, vaccines and biologicals. Introduction guideline- adding a vaccine to a national immunization programme: decision and implementation. WHO. http://whqlibdoc.who.int/hq/2005/WHO_IVB_05.18.pdf. Cited 4 June 2010