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FDA Panel Weighs Approving HPV Vaccine for Males
Date:9/9/2009

eneral of giving vaccines to boys for a number of reasons," Wyand said. "Clinical trials have shown it's pretty effective -- 90 percent effective in preventing genital lesions [in boys]. Trials in a subset of gay men also found the vaccine to be effective in preventing external lesions, so the signs are pretty clear that it works in guys."

Vaccinating boys would help shield girls, too, the experts added. "It's a sexually transmitted disease, and it takes two people to transmit the virus," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "If the vaccine can reduce the risk of infection in men as well as women, then I believe it should be given to both men and women."

But Gardasil has generated controversy, especially with some conservatives and parents' rights groups who contend the vaccine could promote premarital sex.

The committee will also be ruling on whether to approve a second HPV vaccine, GlaxoSmithKline's Cervarix, for girls and women aged 10 to 25. Studies have shown the vaccine prevents infection with HPV 93 percent of the time.

Gardasil, which was approved for girls in 2006, covers four types of HPV, two of which cause about 70 percent of cervical cancers worldwide.

Since its approval, Gardasil has proven to be safe and nearly 100 percent effective in preventing precancerous cervical lesions from the four HPV strains targeted by the vaccine, according to studies. However, there have been side effects reported that include fainting and blood clotting. Research published last month found that for every 100,000 doses of HPV vaccine distributed, there were 8.2 episodes of fainting and 0.2 episodes involving blood clotting.

Studies have also found that Gardasil is much more effective when given to girls or young women -- before they become sexually active.

"The reason you give this is to prevent disease and that's why we start at 11 or 12, be
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