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HPV Vaccine Monitoring

Human Papillomavirus (HPV) Vaccine Post-Licensure Monitoring and Implementation Activities (Updated June 2011)

Two HPV vaccines are licensed for use in females in the United States, the quadrivalent HPV vaccine (Gardasil), which protects against HPV types 6, 11, 16 and 18, and the bivalent HPV vaccine (Cervarix) which protects against types 16 and 18).  The quadrivalent HPV vaccine is licensed for use in males.  The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of females and males aged 11 or 12 years with three doses of HPV vaccine.  The vaccination series can be started as young as 9 years of age.  Catch up vaccination is also recommended for females 13 through 26 years of age who have not been previously vaccinated or who have not completed the full series.  Catch up vaccination is recommended for males 13 through 21 years of age (through age 26 years for men who have sex with males and immunocompromised persons) who have not been previously vaccinated or who have not completed the full 3 dose series.

HPV is the most common sexually transmitted infection in the United States, with approximately 20 million people currently infected, including an estimated 6.2 million 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 United States, 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 collaborative activities among multiple centers and divisions at CDC, including the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of STD Prevention; National Center for Immunization and Respiratory Diseases (NCIRD); National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Division of Cancer Prevention and Control; National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Immunization Safety Office (ISO) and Division of High-Consequence Pathogens and Pathology; and National Center for Health Statistics.

 
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