Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X

Reviews
A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD
Paolo Bonanni, Catherine Cohet, Susanne K. Kjaer, Nina B. Latham, Paul-Henri Lambert, Keith Reisinger, Richard M. Haupt

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.