FDA Considers HPV Vaccine for Males

Special Report - January 8, 2009
The makers of the Gardasil vaccine, which prevents four strains of HPV (human papillomavirus)—including those responsible for most cervical cancers and genital warts—are seeking government approval to make it available for males now. Currently, the vaccine is only available for women ages nine to 26. Merck, which produces Gardasil, received approval from the U.S. Food and Drug Administration (FDA) in 2006 to provide the vaccine to females as a means of preventing the contraction of certain strains of HPV, the most prevalent viral sexually transmitted disease in the United States.

While, 90 percent of HPV cases clear themselves after a year or two, 13 of the nearly 40 strains of HPV can cause cancer. Gardasil prevents HPV-16 and HPV-18, both of which are high–risk strains believed to cause about 70 percent of all cervical cancer in women. The other two strains targeted by the vaccine cause genital warts. Merck sees Gardasil as a means of protecting men from the genital warts, penile cancer, and cancers of the oral cavity, tonsil, and base of the tongue that are more commonly seen in men than in women.

Merck submitted its application to the FDA in late December and hopes to have the vaccine approved for males age nine to 26 by the end of 2009. According to a recent study by Merck, Gardasil was found to be about 90 percent effective in preventing external lesions caused by the four targeted HPV strains, and 45 percent effective in preventing HPV infection. Men may be unknown carriers of HPV, as it does not always cause genital warts or cancer, but can still spread the virus to their sexual partners.

Merck is also seeking approval to make the vaccination available to older women up to age 45, but has been confronted with concerns about cost-effectiveness. Gardasil is one of the most expensive vaccinations on the market, coming in at $360 for a three-dose regimen. It was one of Merck’s primary sources of income in 2008, providing $1.6 billion in revenue. Additional concerns have been raised about the duration of immunity, since both the research and availability of the vaccine is all short-term at this point. Booster shots may be needed for the duration of patients’ sexually active lives.

Currently, the FDA is reviewing Merck-competitor GlaxoSmithKline’s Cervarix vaccine, which also prevents cervical cancer in women and is available internationally, but not in the United States. For more information on HPV, see Dr. Joseph Zanga’s article The HPV Vaccine: Deciding for Our Children.

“While HPV vaccines provide a good in protecting young men and women from STDs and cancer, they do a great disservice by neglecting to treat the underlying problem: sexual promiscuity,” said Matt Lytle, director of research for the North Carolina Family Policy Council. “By seeking to eliminate some of the negative effects of promiscuous sexual activity, vaccines such as Gardasil may actually encourage more promiscuous activity, thereby exacerbating the problem instead of helping it.”

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