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Gardasil Approved to Prevent Anal Cancer

February 2011

In the U.S. more than 5,000 people are diagnosed with anal cancer each year. More women than men are diagnosed with it, and people living with HIV experience higher rates of the cancer, especially gay and bisexual men who have had anal sex. Treatment is challenging and can include surgery, radiation or chemotherapy.


The Gardisil vaccine is currently used to prevent certain diseases caused by the human papillomavirus (HPV) in women, such as genital warts, abnormal skin cells of the cervix and cervical cancer. With this recent change, the vaccine has now been approved by the FDA to prevent abnormal skin cells of the anus and anal cancer in men and women. This applies to people 9-26 years of age before sexual activity has started.

Gardisil was studied in a large international study of gay men, who have high rates of anal cancer. Results showed a 78% reduction in cases of HPV-related abnormal skin cells of the anus. Although only men were studied, women are included in the change since the disease is the same in both sexes. Both men and women who are at higher risk for anal cancer, including gay men and HIV-positive men and women, should continue routine screening even after getting the vaccine.

However, despite this change by the FDA, the CDC still states the vaccine as being optional for boys and young men, which means that the vaccine cost will likely not be covered by public or private health insurance. More advocacy is taking place to encourage theCDC to change its position.

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