An FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts. The FDA advisory committee ruled 7 to 0, with one abstaining vote, that Gardasil's clinical trial data support the vaccine's effectiveness at preventing genital warts in males ages 9 to 26. And in a 7 to 1 vote, the advisory committee ruled that the data show Gardasil to be safe for males in that age range.
Each year, about 200 out of 100,000 males are newly diagnosed with genital warts, according to background information cited by the FDA. Penile cancer and anal cancer are much rarer.
Gardasil already has FDA approval for use in females ages 9 to 26. In females, HPV can cause cervical cancer.
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