The Centers for Disease Control and Prevention (CDC) has adopted recommendations for Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) use in girls and women age 11 to 26.
Human papillomaviruses (HPV) consist of more than 100 different viruses. Some types of HPV cause warts on the hands or feet; others cause genital warts; and some have been linked with cancer, most notably cervical cancer. The types of HPV most commonly linked with cervical cancer are HPV 16 and HPV 18, but several other high-risk types contribute to cancer as well.
The types of HPV that cause cervical cancer or genital warts are transmitted sexually. HPV infection is extremely common and generally occurs soon after an individual becomes sexually active. Although most infections resolve on their own, some persist and can lead to precancerous or cancerous changes to the cervix, vulva, vagina, penis, and anus.
Gardasil prevents infection with four types of HPV-types 6, 11, 16, and 18. HPV types 16 and 18 cause roughly 70% of all cases of cervical cancer, and HPV types 6 and 11 account for roughly 90% of genital warts. Gardasil was approved by the U.S. Food and Drug Administration (FDA) in June 2006.
Following FDA approval of Gardasil, use of the vaccine was discussed by the Advisory Committee on Immunization Practices (ACIP). The members of the ACIP are appointed by the Secretary of the U.S. Department of Health and Human Services (HHS). The role of the ACIP is to advise the director of the Centers for Disease Control and Prevention (CDC) and the Secretary of HHS about vaccine usage and vaccine-preventable diseases. The ACIP unanimously adopted guidelines in the recommendation of Gardasil, which have been finalized by the CDC.
The following are CDC recommendations for the use of Gardasil:
• 11-12 year old females (and as early as 9 years of age)
• 13 to 26 year old females who have not been previously vaccinated or who have not completed the full series of vaccines
• Females who have had a previous abnormal or unclear Pap test, a positive HPV test or a diagnosis of genital warts
• Testing for HPV or a Pap test is not necessary prior to vaccination
• Protection from Gardasil is effective against HPV types that have not already been acquired prior to the vaccine
• According to clinical trials data, Gardasil does not provide a therapeutic effect on cervical lesions, genital warts of HPV infection that already exists at the time of vaccination.
Females, or parents of females, should speak with their physician regarding their individual risks and benefits of Gardasil.
Reference: Merck. CDC Finalizes Advisory Panel Recommendations for Gardasil®, Merck’s Cervical Cancer Vaccine. Available at: http://www.merck.com/newsroom/press_releases/product/2007_0322.html. Accessed April 2007.