FDA Approval Sought for Male HPV Vaccine

via The Daily Free Press An advisory panel submitted a human papillomavirus vaccine for men to the Food and Drug Administration for approval last Wednesday, National Cervical Cancer Coalition officials said.

New evidence indicate that HPV has a direct effect on men, NCCC chairman Alan Kaye said.

“Evidence is indicating that HPV is directly associated with penile cancer, anal cancer and 30 percent of head and neck cancer,” he said. “Men have a personal stake in preventing HPV.”

The advisory panel submitted men’s Gardasil to the FDA alongside another vaccine option for women, GlaxoSmithKline’s Ceravix, Kaye said.

Clinical trials showed Gardasil to effectively prevent genital warts caused by HPV in men, Kaye said. Ceravix, on the other hand, would be a competitor to women’s Gardasil, the only HPV vaccine currently available, hopefully reducing the cost and allowing more women to get the shot.

Gardasil was approved for use in women ages nine to 26 years in 2006. The vaccine entails three shots administered over a six-month period. It prevents HPV types 16 and 18, which cause approximately 70 percent of cervical cancers, and HPV types 6 and 11, which cause about 90 percent of genital warts, according to the FDA.

Efforts to approve further HPV vaccines come amid concerns that Gardasil causes more side effects than originally thought. A study published in the Journal of the American Medical Association in August reported 6.2 percent of the 12,424 reported immunizations were followed by serious adverse reactions, including 32 deaths.

Still, students and experts alike said the alarming frequency of HPV among college communities and the population at large warrant the risk to vaccinate. HPV rarely manifests symptoms, meaning diagnoses for women is possible only through Pap tests and for men only if there are visible warts, according to Boston University Student Health Services.

“HPV is the most common sexually transmitted disease in the United States,” Planned Parenthood League of Massachusetts Communications and Public Awareness Director Melanie Lown said. “At least half of all sexually active people will contract some form of HPV in their lifetime.”

Condoms lower the risk of HPV but do not completely protect against it, she said.

Lown stressed the importance of being proactive in sexual health.

“Access to preventive sexual health care is critical for young men and women to be able to lead safe and healthy lives,” Lown said.

BU Student Health Ambassador Krista Lee Berardi said she received the three Gardasil shots at Student Health Services and recommended the vaccine “100 percent.”

“It was really quick, really easy, and it’s worth it,” Berardi, a College of Arts and Sciences junior, said. “It’s not [effective against] all strains, but it’s something rather than nothing.”

Her fellow student ambassador Laura Greco, a CAS senior, said she thinks the male-targeted vaccine in particular is a good idea, but is unsure if men would actually go through the process and cost to get the vaccine.

“I don’t think a lot of guys would get it,” she said. “It’s symptomless and it doesn’t affect men as much as it affects women.”

CAS junior Greg Karahalis said he thinks men would not want to get the vaccine solely to prevent transmission to women.

“I feel like it doesn’t consciously cross men’s minds very much [that they could transmit the disease],” he said. “If it actually affected their health, I think they’d be much more inclined.”

He said he would most likely get the vaccine if it was free. If it was expensive – the women’s Gardasil costs $375 total for the series – he said he thinks men would be “exponentially less inclined.”