The U.S. Food and Drug Administration approved the vaccine Gardasil today (Dec. 22) for the prevention of anal cancer caused by the human papillomavirus (HPV) for people ages 9 to 26.
Gardasil had already been approved by the FDA to prevent cervical, vulvar and vaginal cancers, as well as precancerous lesions caused by four types of HPV in females (types 6, 11, 16 and 18). It was also approved last year to prevent genital warts caused by HPV types 6 and 11 in males ages 9 to 26.
While HPV types 6 and 11 are considered low risk, 16 and 18 are high risk and account for 70 percent of all cases of cervical cancer, according to the Mayo Clinic.
“Treatment for anal cancer is challenging,” Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. “The use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure.”
HPVs account for approximately 90 percent of anal cancers. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.
Gardasil has the ability to prevent 78 percent of anal-cancer and precancerous lesions caused by HPV types 16 and 18, according to the FDA. The vaccine is also approved to prevent anal-cancer lesions caused by HPV types 6 and 11.
Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination, according to the FDA.
The vaccine, produced by Merck and Co., was first approved by the FDA in 2006. It does not protect against diseases caused by HPV types not contained in the vaccine, the FDA said.
Pass it on: The FDA approved the vaccine Gardasil for prevention of anal cancer caused by certain types of human papillomavirus.
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