HPV Vaccine Recommended for Males

(Sept. 9th) A FDA advisory committee recommends HPV vaccine Gardasil be approved for use in boys and men ages 9 to 26 for the prevention of genital warts caused by human papilloma virus (HPV) types 6 and 11, based on data related to efficacy, immunogenicity and safety from clinical trials data.

"Merck has been committed to pursuing the use of GARDASIL in both males and females since the vaccine was discovered over a decade ago," said Peter S. Kim, Ph.D., executive vice president, and president of Merck Research Laboratories.  "We are pleased that the Advisory Committee agrees that the data support the use of GARDASIL in boys and men.”

HPV types 6 and 11 cause approximately 90 percent of genital warts cases.  About one million people (both males and females) have visible genital warts at any point in time.  There are currently no routine HPV screening methods in place for men. 

More than 60% of men without HIV and 90% of men with HIV who have sex with men are infected with various types of HPV in their anal canals, according to the CDC.

The vaccine may also have implications for the increasing incidence of anal cancer amongst black, gay men as it also prevents HPV types 16 and 18.  HPV type 16 has been found in 86% of anal cancer specimen in a study discussed in the New England Journal of Medicine.

HPV can also reside in the anus.  Anal HPV infections are one cause of a rising incidence of anal cancer, especially among men that have sex with men.

The incidence of anal cancer among black, gay men increased from 1 in 100,000 in 1970 to 3 in 100, 000 in 2000. 

Additionally, black men had a five-year-survival rate of 62 percent as compared to 79 percent for white men with localized cancer in with early stage disease.

HPV is the most prevalent STD and the best way to prevent infection is by not having sex.  Condoms do not offer complete protection against HPV infection.

The papilloma virus lives in the cells of the outer skin as well as inside the body, mainly in the vagina, anus and urethra. When condoms do not cover the entire shaft of the penis or the pubic skin, papilloma-laden skin cells can easily pass from a man’s pubic area into the vagina, vulva or anus, according to the American Social Health Association.

The committee’s recommendation will be considered by the FDA and a decision should be rendered before the end of the year.

“Today's discussion with the Advisory Committee brings the public health community closer to being able to provide GARDASIL to both men and women," said Anna R. Giuliano, Ph.D., Moffitt Cancer Center.