1Centro di Documentazione sulla Salute Perinatale e Riproduttiva - SaPeRiDoc - Centro per la valutazione dell’efficacia dell’assistenza sanitaria, CeVEAS, Azienda USL di Modena
2Pediatra di famiglia, Azienda USL di Ferrara
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Key words: Human papillomavirus, Vaccine, Adolescent, Randomised controlled trial, Efficacy
The recent introduction in the European market of the tetravalent vaccine against Human Papillomavirus raises some concerns on the opportunity to start a national vaccination campaign. In this article an analysis of the currently available evidence, a reflection on what the experts in the field add to the international debate and a comparison between the decision taken in other countries on this issue are presented to guide an informed decision making process on this topic. We searched Pubmed-Medline for RCT on vaccine efficacy. Eight RCT were identified: three studies were related to the bivalent vaccine, and five to the tetravalent vaccine (one describing the Finnish experience of field testing of the tetravalent vaccine efficacy). Flaws related to the presentation of trial results were identified and discussed. The critical analysis of the trials shows that at the moment there is no evidence that implementing a mass vaccination campaign can effectively reduce cervical cancer incidence. Researchers and experts in the field, mirroring the lack of evidence, assume various positions: some of them highlight the theoretical advantage of the vaccine, some of them discuss the limits and information gap still existing and call for more prudence. Moreover, in October 2007, eight out of 27 countries within the European Union took the decision to include the vaccine against Human Papillomavirus in their national immunization campaign. Italian policy makers could consider funding field researches on vaccine efficacy in the Italian context instead of proposing a premature implementation of a mass vaccination campaign.
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