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FDA Approves Gardasil to Prevent Genital Warts in Males. Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
American Family Physician, 10/22/09

The FDA has expanded its approval of Merck & Co. Inc.'s quadrivalent human papillomavirus, or HPV, vaccine, which is marketed as Gardasil, to include use of the vaccine to prevent genital warts in boys and men ages 9–26 years. The agency also has given a thumbs–up to a bivalent HPV vaccine for girls and young women. During clinical trials in more than 4,000 males, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11. Gardasil was approved in 2006 for use in girls and young women ages 9–26 years for the prevention of cervical cancer, vulvar cancer, vaginal cancer and precancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18. Merck's vaccine soon will have competition from GlaxoSmithKline Biologicals, or GSK. The FDA approved GSK's bivalent HPV vaccine, Cervarix, on Oct. 16 for the prevention of cervical cancer and precancerous lesions caused by HPV types 16 and 18 in girls and women ages 10–25.

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