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HPV Vaccine Monitoring

Human Papillomavirus (HPV) Vaccine Post-Licensure Monitoring and Implementation Activities

In June 2006, the quadrivalent HPV vaccine (GARDASIL ®) was licensed by the Food and Drug Administration for use in females 9 through 26 years of age. The vaccine protects against HPV types 6, 11, 16 and 18. The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of 11 through 12 year old females and catch up vaccination of females 13 through 26 years of age.

Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States, with approximately 20 million people currently infected and an estimated 6.2 million additional people who become newly infected every year. More than 100 HPV types have been identified, over 40 of which can infect the genital area. High risk, or oncogenic types, including types 16 and 18, can cause high-grade cervical cell abnormalities that are precursors to cervical cancer and other cancers such as vulvar, vaginal and anal cancers as well as some oropharyngeal cancers. Low risk, or non-oncogenic types, such as HPV 6 or 11, can cause benign or low-grade abnormalities of cervical cells, genital warts, and a disease of the respiratory tract called recurrent respiratory papillomatosis. Most HPV infections are transient and asymptomatic, causing no clinical manifestations.

In the U.S., post-licensure vaccine monitoring routinely includes determination of vaccine coverage, monitoring for disease impact, vaccine safety and vaccine implementation. For HPV vaccine, other areas will also need to be monitored, including sexual behavior and cervical cancer screening. Human Papillomavirus (HPV) Vaccine Post-Licensure Monitoring and Implementation Activities outlines established efforts for post-licensure monitoring; to which HPV has been added, as well as new efforts and activities at CDC. These efforts are a collaboration among multiple centers and divisions at CDC, including National Center for HIV/AIDS, Viral Hepatitis, STD, TB Prevention, Division of STD Prevention; National Center for Immunization and Respiratory Diseases; National Center for Chronic Disease Prevention and Health Promotion, Division of Cancer Prevention and Control; National Center for Zoonotic, Vector-Borne, and Enteric Diseases, Division of Viral and Rickettsial Diseases; National Center for Health Statistics; and the Immunization Safety Office.

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