Boys' Use of Gardasil Is Approved

On Friday, the Food and Drug Administration approved Merck & Co.'s human papillomavirus vaccine Gardasil as safe and effective at protecting males from genital warts caused by HPV types 6 and 11. FDA approved the vaccine's use by males ages 9-26. Gardasil is already approved for use by females ages 9-26 to prevent cervical, vulvar and vaginal cancer, precancerous lesions, and genital warts.

Each year, about two of every 1,000 US men are newly diagnosed with genital warts, FDA said. A panel of experts is scheduled the week of Oct. 18 to discuss whether the vaccine should be routinely given to boys; CDC already recommends the vaccine for girls ages 11-12. The issue is complicated by the fact that only about 1 percent of sexually active US males develop genital warts, which -- unlike cervical cancer -- are not life-threatening. However, vaccinating males could help prevent HPV transmission to women.

"Are boys -- or their parents, more to the point -- going to be altruistic and get a vaccine so it benefits somebody else?" asked Steven Epstein, a Northwestern University sociologist who studies vaccine-related social issues.

"It may seem unfair: Should this burden be borne by only girls and women?" asked Nancy Berlinger of the Hastings Center, a nonprofit bioethics research institution.

Back to other news for October 2009