Merck approves use of its HPV vaccine Gardasil in males

Soon girls may not be the only ones getting Gardasil injections.

Merck Frosst is moving ahead with plans to extend the use of its controversial Gardasil vaccine to boys and young men.

The cancer vaccine for women could be just as effective for men, Universite de Montreal professor and microbiologist Francois Coutlee said Thursday in a telephone interview at a scientific meeting in Nice, France.

Coutlee was part of the team reporting early results of a Merck-sponsored study showing that 90 per cent fewer men ages 16 to 26 years old developed genital warts and other lesions after receiving Gardasil, a vaccine that targets four human papillomavirus strains that can lead to cancer.

But HPV isn't just a problem for women, Coutlee said. In men, HPV can lead to genital warts, anal cancer, and penile cancer.

"The study is still ongoing, but we're relieved to know that it is as effective in men as it is in women," said Coutlee, who was involved in recruiting test subjects in Montreal.

The vaccine was tested against a placebo in 4,000 men. The vaccinated group had three cases of genital warts compared to 35 cases in the control group that didn't get the vaccine.

Finally, two years after it was approved for use in young women, a vaccine against the sexually transmitted human papillomavirus (HPV) has now been shown to be safe and effective in protecting young men as well. Merck's vaccine Gardasil cut infections caused by the four most dangerous strains of this virus by 45 percent and reduced the occurrence of HPV-induced warts by 90 percent, according to a new study involving more than 4,000 male volunteers age 16 to 26. The next step is for the Food and Drug Administration to give its blessing.

The delay in studying the vaccine in men has puzzled me. Men are, after all, carriers of this virus known to infect the female cervix, leading to a virtual epidemic of abnormal Pap smears in sexually active young women. Although in most women the virus is cleared by their immune system, when it's not it continues to percolate for years and each year accounts for the almost 11,000 cancers of the cervix—a cancer that robs women of their fertility if not their life. Ignoring the role of men in promulgating this illness is at odds with how we approach most other forms of STDs, where doctors treat both partners. Leaving men out also subverts the core tenet of vaccination: creating so-called herd immunity.