FDA Approves Gardasil For Men
In the United States, the most prevalent sexually transmitted disease (STD) today is the human Papillomavirus (HPV). Several health issues have been linked to HPV including genital warts, cervical cancer, and penile cancer. The United States Food and Drug Administration (FDA) approved two separate vaccines to prevent HPV.
Up until recent times, the Gardasil vaccine was only made available to young girls and women. But as of October 2009, the vaccine was approved by the FDA for boys and men aged 9-26. The manufacturer says that Gardasil acts to prevent genital warts (condyloma acuminate) due to HPV types 6 and 11.
Merck and Company Inc., which is based in Whitehouse Station, New Jersey, is the sole manufacturer of the vaccine, which was approved by the FDA back in 2006 for girls and women between the ages of 9-26. The manufacturers say that Gardasil protects women against genital warts arising from HPV types 6 and 11; precancerous lesions from HPV types 16 and 18; and cervical and vulvar cancers caused by HPV types 16 and 18. Now, Merck is awaiting FDA approval to use Gardasil in older women.
HPV types 16 and 18 are believed to be responsible for up to 70% of cervical cancer cases, throughout the world. According to statistics from the National Cancer Institute, which is associated with the National Institutes of Health (NIH), there were 11,270 new cases of cervical cancer and 4,070 deaths due to cervical cancer in the year 2009.
Karen Midthun, M.D., acting director for the FDA's Center for Biologics Evaluation and Research says, "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."
Gardasil is given in three doses within a six-month span. The vaccine may cause itching, fever, headache, bruising, redness, swelling, and pain at the injection site. These are the most common side effects as seen during clinical trials.
In order to establish the efficacy of Gardasil in boys and men, researchers carried out a randomized clinical trial including 4,055 men between the ages of 16-26. In those participants not infected with HPV types 6 and 11 at the start of the trial, the vaccine was found to be nearly 90% effective at the prevention of genital warts due to infection with these types of HPV.
Other studies focused on whether younger men, aged 9-15 would derive benefit from Gardasil. The researchers found that the response in this age group was the same as it was in 16-26 year-old men. Further studies are planned to evaluate the safety and efficacy of Gardasil for men and boys.