FDA Panel Weighs Approving HPV Vaccine for Males

By Amanda Gardner
HealthDay Reporter

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."

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, before girls are sexually active," said Dr. Lolita McDavid, medical director of Child Advocacy and Protection at University Hospitals Case Medical Center in Cleveland. "About 10,000 American women will get cervical cancer in a year; about 3,700 are going to die from it."

"About 250,000 new case of genital warts appear in males every year," she added. "There certainly seems to be a benefit for males."