The US Centres for Disease Control and Prevention (CDC) has adopted the unanimous recommendation of its Advisory Committee on Immunization Practices (ACIP) for the use of Gardasil Quadrivalent Human Papillomavirus in girls and women ages 11 through 26.
Gardasil is indicated to help prevent cervical cancer, precancerous and low-grade cervical lesions, vulvar and vaginal precancers and genital warts caused by human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccination guidelines, published in the CDC's Morbidity and Mortality Weekly Report (MMWR), and now available to physicians, finalize the provisional recommendations issued by the ACIP in June 2006.
The guidelines state that routine vaccination with Gardasil is recommended for 11- and 12-year-old females and for females ages 13 to 26 who have not previously been vaccinated or who have not completed the full series, and that vaccination with Gardasil can be started at nine years of age.
Additionally, the guidelines highlight that Gardasil can be administered to females even if they have or previously had an abnormal or unclear Pap test, a positive HPV test or genital warts. Pap testing and screening for HPV DNA or HPV antibody are not needed before vaccination at any age.
Gardasil can help protect females against disease due to vaccine HPV types not already acquired. Females should be advised that data from clinical trials do not indicate the vaccine will have any therapeutic effect on existing cervical lesions, genital warts or HPV infection.
"The CDC's decision to adopt the vaccination recommendations put forth by the ACIP is an important milestone in cervical cancer prevention," said Margaret G. McGlynn, president, Merck Vaccines. "We look forward to continuing to work with the public health community, physicians, parents and others to support the implementation of this broad recommendation for Gardasil to help achieve our common public health goal of reducing the burden of cervical cancer and HPV-related diseases for as many females as possible, as quickly as possible."
Gardasil helps protect against the four HPV types that cause the most HPV disease Gardasil has been studied for more than a decade in more than 25,000 individuals, including 1,124 adolescent girls ages 9 to15.