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FDA approves new HVP vaccine, extends vaccine use to men and boys

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The human papillomavirus, commonly referred to as HPV, is the most common sexually transmitted infection in the United States and has been linked to a host of illnesses from cancer to genital warts. The Food and Drug Administration has now approved two vaccines for protection from HPV.

The FDA gave Gardasil a green light in October 2009 to be the first such product to be administered to males between the ages of 9 and 26 for the prevention of genital warts (condyloma acuminata) due to HPV types 6 and 11. It also granted a license for Cervarix for use in women and girls to prevent cervical cancer and precancerous lesions caused by HPV types 16 and 18.

Gardasil, manufactured by Merck and Company Inc. of Whitehouse Station, N.J., was first approved by the FDA in 2006 for girls and women, ages 9 to 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11. The company is currently seeking FDA approval for use in older women.

HPV types 16 and 18 cause about 70 percent of cervical cancers worldwide. An estimated 11,270 new cases and 4,070 deaths from cervical cancer occurred in the United States in 2009, according to the National Cancer Institute at the National Institutes of Health.

“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,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Gardasil is given as three injections over a 6-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, were the most common side effects observed during clinical trials.

For men and boys, Gardasil’s effectiveness was studied in a randomized trial of 4,055 males ages 16 through 26-years-old. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, the vaccine was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.

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Expert HERWriter Guide Blogger

Hi Lynette - It will be interesting - in the future - to see if boys being taught to take steps to prevent sexually transmitted disease at an early age will have an impact on they way they treat themselves and their partners. Thanks for bringing us this important new information. Pat

January 13, 2010 - 6:08pm
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