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DAVID J. HUTCHINSON, PHARM.D., is Assistant Professor of Pharmacy Practice, Wegmans School of Pharmacy at St. John Fischer College, Rochester, NY; at the time of writing he was Pediatrics Specialty Resident and Clinical Instructor, University of Michigan Hospitals and Health Centers (UMHHC), Ann Arbor. KRISTIN C. KLEIN, PHARM.D., is Clinical Pharmacist, Pediatric Infectious Diseases, and Clinical Assistant Professor, Pharmacy Services and College of Pharmacy, UMHHC.

Address correspondence to Dr. Klein at the University of Michigan Hospitals and Health Centers, 1500 East Medical Center Drive, MCHC F2758/0221, Ann Arbor, MI 48109-0008 (kriklein{at}umich.edu).

Purpose. Human papillomavirus (HPV) disease and vaccines and several controversial issues associated with vaccine administration are reviewed. Summary. HPV infection is the most common sexually transmitted disease in the United States. It is estimated that 20 million individuals are currently infected with HPV, with 6.2 million new infections occurring each year. Although most HPV infections are benign and are often cleared without clinical sequelae, persistent infections are associated with the development of cervical cancer in women and genital warts in both women and men. The identification of the most common disease-causing HPV types has led to the development of a quadrivalent vaccine and a bivalent vaccine. The prophylactic administration of the quadrivalent vaccine has resulted in a 96% efficacy in preventing persistent infection associated with HPV types 6, 11, 16, and 18. Similar to the quadrivalent vaccine, the bivalent vaccine is highly efficacious (96%) in preventing persistent infection against vaccine-specific HPV types (HPV-16 and HPV-18) among women who were HPV seronegative at the time of vaccination. However, many controversial issues still remain regarding routine administration and widespread acceptance. These include appropriate age at time of vaccination, parental concerns, vaccination of men or women age 26 years or older, inadequate long-term efficacy and safety data, and potential for nonvaccine-related strains to emerge as prominent oncogenic serotypes. Conclusion. HPV vaccines provide a high level of protection for seronegative women against persistent infection and precan-cerous cervical lesions associated with vaccine-specific HPV types. However, many controversial issues still remain regarding the vaccines’ routine administration and widespread acceptance. Index terms: Epidemiology; Immunization; Papillomavirus infections; Papillomavirus vaccines; Protocols; Toxicity; Vaccines