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FDA Panel Backs Giving HPV Vaccine Gardasil to Young Males
The advisors also recommend approval of second HPV vaccine, Cervarix, to prevent cervical cancer
By Amanda Gardner
HealthDay Reporter
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WEDNESDAY, Sept. 9 (HealthDay News) -- U.S. drug advisors recommended Wednesday that use of the vaccine Gardasil, already administered to help prevent cervical cancer in women, be expanded to help prevent genital warts in young males.
A U.S. Food and Drug Administration advisory panel voted to recommend the expanded use of the vaccine for males 9 to 26. The FDA is not required to follow its advisory panels' recommendations, but it typically does.
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The vaccine targets the human papilloma virus, which can cause genital warts in both males and females, cervical cancer in women and also penile and anal cancer in men -- although these remain much rarer than cervical malignancies.
The vaccine is manufactured by drug maker Merck & Co.
Merck had asked the FDA to approve Gardasil for males ages 9 to 26. It is already approved in females 9 and older to help prevent cervical cancer.
Before the Gardasil vote, the committee on Wednesday also voted that a second HPV vaccine, GlaxoSmithKline's Cervarix, seems safe for girls and women ages 10 to 25 for the prevention of cervical cancer. Studies have shown that the vaccine prevents infection with HPV 93 percent of the time. The introduction of Cervarix was delayed in 2007 when the FDA said it needed more research on the vaccine.
The FDA advisors -- comprising the Vaccines and Related Biological Products Advisory Committee -- said Wednesday that newer studies suggest the Cervarix vaccine is safe, but they recommended follow-up studies to look for miscarriages and muscular problems reported by a small number of patients, the Associated Press reported.
The vote to expand the use of Gardasil to males was not unexpected among health experts.
"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 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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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 9/10/2009
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SOURCES: Fred Wyand, spokesman, American Social Health Association, Research Triangle Park, N.C.; Jay Brooks, M.D., chairman, hematology/oncology, Ochsner Health System, Baton Rouge, La.; Lolita McDavid, M.D., medical director, Child Advocacy & Protection, University Hospitals Case Medical Center, Cleveland; Jonathan L. Temte, M.D., Ph.D., professor, family medicine, University of Wisconsin School of Medicine and Public Health, and voting member, Advisory Committee on Immunization Practices, CDC; briefing materials, U.S. Food and Drug Administration; Associated Press
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