A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD.

Abstract	GARDASIL has been shown to reduce the incidence of pre-cancerous cervical, vulvar, and vaginal lesions, and external genital warts causally related to HPV6/11/16/18. Because of its expected public health benefit on reduction of cervical cancer and other HPV-related diseases, this vaccine has been rapidly implemented in the routine vaccination programs of several countries. It is therefore essential to assess its impact and safety through post-licensure surveillance programs. Here, we present a summary of 16 post-licensure safety and impact studies across 20 countries. These studies address general safety, including autoimmune disorders, long-term effectiveness, and type replacement. A summary of the surveillance efforts of the Unites States Centers for Disease Control and Prevention can be found in the accompanying article by Markowitz et al.
Authors	Paolo Bonanni, Catherine Cohet, Susanne K Kjaer, Nina B Latham, Paul-Henri Lambert, Keith Reisinger, Richard M Haupt
Journal	Vaccine (Vaccine) Vol. 28 Issue 30 Pg. 4719-30 (Jul 05 2010) ISSN: 1873-2518 [Electronic] Netherlands
PMID	20451636 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
Copyright	Copyright 2010 Elsevier Ltd. All rights reserved.
Chemical References	Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 Papillomavirus Vaccines
Topics	Adolescent Adult Attitude of Health Personnel Child Clinical Trials as Topic Condylomata Acuminata (epidemiology, prevention & control) Drug Industry Europe Female France Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 Humans Licensure Managed Care Programs Papillomavirus Infections (epidemiology, immunology, prevention & control) Papillomavirus Vaccines (adverse effects, immunology) Patient Acceptance of Health Care Product Surveillance, Postmarketing Registries Uterine Cervical Neoplasms (immunology, prevention & control) Young Adult

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