October 21, 2009 Gardasil Vaccine Approved by FDA to Prevent Genital Warts in Men and Boys The U.S. Food and Drug Administration (FDA) approved the use of the Gardasil vaccine for the prevention of genital warts due to human papillomavirus (HPV) in boys and men on Friday, October 16, 2009. “This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.  The effectiveness of Gardasil was studied in a randomized trial of 4,055 males ages 16 through 26 years old.  The results showed that in men who were not infected by HPV types 6 and 11 at the beginning of the study, Gardasil was almost 90 percent effective in preventing genital warts caused by the infection with HPV types 6 and 11. Merck and Company Inc., the manufacturer of the vaccine, will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men. See also: FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys FDA: Gardasil Product Information CHHCS: Adolescents and STDs

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