Cervical Cancer Vaccine Receives FDA Approval

Cervical Cancer Vaccine Receives FDA Approval

The U.S. Food and Drug Administration (FDA) announced that is has licensed Gardasil®-a new vaccine intended to prevent cervical cancer, precancerous genital changes, and genital warts caused by specific types of human papillomavirus (HPV). The vaccine is approved for use in females between the ages of nine and 26 years.

Human papillomaviruses consist of a group of more than 100 different viruses. 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. 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 is administered in three injections over a six-month period.

The vaccine targets HPV types 6 and 11 (linked with genital warts) and HPV types 16 and 18 (linked with cervical cancer, as well as precancerous changes to the cervix, vulva, and vagina). It’s important to note that the vaccine is intended to prevent infection with these types of HPV, and not to treat existing infections or cervical abnormalities.

The safety of the vaccine was assessed in 11,000 individuals. The most common adverse effects of vaccination were mild or moderate local reactions, such as pain or tenderness at the injection site.

Because Gardasil does not prevent infection with all cancer-associated types of HPV, regular cervical cancer screening will remain important even for vaccinated women. The frequency of abnormal Pap tests, however, is likely to be greatly reduced by vaccination.

A study to evaluate the safety and effectiveness of Gardasil in males is underway.

Reference: FDA News. FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus. June 8, 2006. Available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html (Accessed June 8, 2006).

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