The U.S. Food and Drug Administration announced Oct. 16 that it approved the use of the vaccine Gardasil to prevent genital warts caused by the human papillomavirus types 6 and 11 in males ages 9 to 26.
Each year, about two out of every 1,000 men in the United States are newly diagnosed with genital warts.
Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.
HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.
“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.
Studies were conducted to measure the immune response to the vaccine in boys ages 9 through 15. The results showed that the immune response was as good as that found in the 16 through 26 years age group, indicating that the vaccine should have similar effectiveness.
The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.
Merck and Co. of Whitehouse Station, N.J., manufactures Gardasil.