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FDA Panel Recommends HPV Vaccine Gardasil for Males

Agency advisers also announce Cervarix is probably safe for young females

THURSDAY, Sept. 10 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel is recommending that the vaccine Gardasil be given to boys and young men to help prevent genital warts. The same panel has determined that another human papillomavirus (HPV) vaccine, Cervarix, seems safe for preventing cervical cancer in females ages 10 to 25 years.

The Vaccines and Related Biological Products Advisory Committee voted Sept. 9 to recommend the expanded use of Gardasil (Merck), which is already given to females age 9 years and older to help prevent cervical cancer. The new recommendation is for males ages 9 to 26 years. Gardasil targets HPV, which can cause genital warts in both sexes, cervical cancer in females, and penile and anal cancer in males. The latter are much rarer than cervical malignancies.

The FDA panel also determined that Cervarix (GlaxoSmithKline) seems safe in young females. The HPV vaccine's introduction had been delayed in 2007 after the FDA said more research was needed. The advisory panel said that new studies suggest Cervarix is safe. The FDA is not required to follow recommendations from its advisory panels, but typically does.

"It is really hard to get a read on these things, but I don't think anybody is going to be shocked if eventually this [Gardasil] 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.

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