Human papillomavirus (HPV) is one of the most common sexually transmitted diseases and is responsible for the vast majority of cervical cancers worldwide. Treatment is a challenge because the immune response to the virus has not been well characterized, and the virus has a propensity to persist, produce recurrent clinical disease, and cause cancer. Merck's October 2005 announcement that its HPV vaccine, Gardasil, proved to be 100% effective in preventing cervical cancer has excited the medical community but has also triggered debate regarding its inclusion on the U.S. recommended schedule of vaccinations, an inclusion that is often critical for vaccines' commercial success. In this report, we review the prevalence of HPV; discuss Merck's Gardasil and GlaxoSmithKline's Cervarix HPV vaccines; profile the U.S. Advisory Committee on Immunization Practices, which determines which vaccines are included on the U.S. recommended schedule of vaccinations; examine the debate surrounding the vaccines' inclusion on the U.S. recommended schedule of vaccinations; and discuss the implications of this debate for the pharmaceutical industry as a whole.

Introduction

The Impact of HPV on World Health