Gardasil Approved Prevent Genital Warts in Men and Boys

The FDA has approved the Gardasil vaccine to prevent genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in males ages 9 to 26.
Each year, about two out of every 1,000 men in the U.S. are diagnosed with genital warts. HPV is the most common sexually transmitted infection in the US, and most genital warts are caused by HPV infection.

Gardasil was first approved for girls and women ages 9 to 26 to prevent cervical, vulvar and vaginal cancer caused by HPV types 16 and 18, precancerous lesions caused by types 6, 11, 16 and 18, as well as genital warts caused by types 6 and 11.

"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, MD, acting director of the FDA's Center for Biologics Evaluation and Research.

The vaccine's effectiveness was studied in a randomized trial of 4,055 males ages 16 to 26. The results showed that in participants 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.

Studies were conducted to measure the immune response to the vaccine in boys ages 9 to 15. The results showed the immune response was as good as that found in the 16-to-26 age group, indicating the vaccine should have similar effectiveness.

The manufacturer, Merck, will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Gardasil is given as three injections over a six-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising were the most common side effects observed.

Contact:
Shelly Burgess
301-796-4651
shelly.burgess@fda.hhs.gov