FDA Panel Weighs Approving HPV Vaccine for Males

Sept. 9 -- WEDNESDAY, Sept. 9 (HealthDay News) -- A U.S. health advisory committee on Wednesday will discuss whether or not to approve Gardasil, a vaccine that targets sexually transmitted human papillomavirus (HPV), for use in boys as well as girls.

Merck & Co., which makes the vaccine, has asked the U.S. Food and Drug Administration to approve Gardasil for males aged 9 to 26. It is already approved in females aged 9 and older to help prevent cervical cancer.

The FDA is not bound to follow the recommendations of its committees -- in this case the Vaccines and Related Biological Products Advisory Committee -- but it usually does. And while it's unclear how the committee will vote, a nod toward approving Gardasil for males would not be a huge surprise, experts said.

"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," said Fred Wyand, a spokesman for the American Social Health Association, in Research Triangle Park, N.C.

"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 feel it makes sense to vaccinate boys against the virus, which causes 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).

"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."