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FDA Panel Backs Giving HPV Vaccine Gardasil to Young Males
Date:9/9/2009

shocked if eventually this is extended to boys, especially since the science is pretty solid here," Fred Wyand, a spokesman for the American Social Health Association, in Research Triangle Park, N.C., said before the vote.

"I would not be surprised at all if FDA approved the new indication," agreed Dr. Jonathan L. Temte, a professor of family medicine at the University of Wisconsin School of Medicine and Public Health in Madison.

Temte is also a voting member of the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) and explained that if the FDA approves the new use for males, the CDC committee can expect to see the item on its agenda in October.

Health experts believe it makes sense to vaccinate boys against the HPV virus.

"We're supportive in general 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.

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 effectiv
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