FDA approves Merck’s Gardasil vaccine for the prevention of genital warts in boys and men 9 to 26

The U.S. Food and Drug Administration approved use of Merck’s Gardasil vaccine for the prevention of genital warts (condyloma acuminata) due to HPV types 6 and 11 in boys and men, ages 9 through 26, noting that each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts. Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research, said, “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.” Gardasil’s effectiveness 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 start of the study, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm

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