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

Paolo Bonannia, Catherine Cohetb, Susanne K. Kjaerc, d, Nina B. Lathamb, Paul-Henri Lamberte, Keith Reisingerf and Richard M. Hauptg, Corresponding Author Contact Information, E-mail The Corresponding Author

a University of Florence, Florence, Italy

b Sanofi Pasteur MSD, Lyon, France

c Gynecologic Clinic, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

d Institute of Cancer Epidemiology, Danish Cancer Society, Copenhagen, Denmark

e Centre of Vaccinology, Geneva, Switzerland

f Primary Physicians Research, Pittsburgh, PA, USA

g Merck Research Laboratories, West Point, PA, USA

Received 14 October 2009;

revised 4 March 2010;

accepted 23 April 2010.

Available online 6 May 2010.

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.

Keywords: HPV vaccine; Monitoring; Post-licensure

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.