Gardasil Use Extended To Men And Boys

The most common sexually transmitted disease (STD) in the United States today is the human papillomavirus (HPV). HPV has been linked to many physical conditions, such as genital warts and various types of cancer. The Food and Drug Administration (FDA) has now approved two vaccines to protect against HPV.

Boys, Too

Until now, the Gardasil vaccine was available only to girls and women. As of October 2009, the FDA has now approved the vaccine for males between the ages of 9-26 as a preventative measure against genital warts (condyloma acuminate) that are caused by the HPV types 6 and 11.

The Whitehouse Station, New Jersey-based Merck and Company Inc., is the manufacturer of the Gardasil vaccine, which received approval from the FDA in 2006 to be used in females aged 9-26 for the prevention of genital warts, caused by HPV types 6 and 11, precancerous lesions due to HPV types 6, 11, 16, and 18, and vaginal, vulvar, and cervical cancer due to HPV types 16 and 18. At present, Merck is waiting for FDA approval for Gardasil use in older women.

It has been estimated that HPV types 16 and 18 are responsible for some 70% of cervical cancer cases worldwide. In 2009, there were 11,270 new cases of cervical cancer as well as 4,070 cervical cancer deaths. This is according to statistics gathered by the National Cancer Institute at the National Institutes of Health (NIH).

Avoid Warts

According to Karen Midthun, M.D., the acting director of the FDA's Center for Biologics Evaluation and Research, “Gardasil is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts."

The Gardasil vaccine is given in three shots over the course of half a year. The most common side effects seen during clinical trials were headache, fever, itching, swelling, redness, bruising, and pain at the site of the injection.

To test the effectiveness of Gardasil in men and boys, research was carried out during a randomized trial of 4,055 male participants aged 16-26. In men not infected by HPV types 6 or 11 at the inception of the trial, the vaccine was seen as being almost 90% effective in preventing genital warts due to infection with HPV types 6 and 11.

Immune Response

Studies were also performed with an eye toward measuring the immune response of boys aged 9-15 to the vaccine. The results proved that immune response was the same in this younger group as it was for the 16-26 year-olds. This indicates that the vaccine would be just as effective in this younger age group. Merck plans to conduct further studies to collect data on the effectiveness and safety of the Gardasil vaccine in men and boys.