Image: JoNel Aleccia
By JoNel Aleccia Health writer
msnbc.com
updated 12/22/2010 3:30:21 PM ET 2010-12-22T20:30:21

The Food and Drug Administration has agreed to expand the use of the popular HPV vaccine Gardasil to prevent anal cancer in young women and men, agency officials said Wednesday.

The move approves the use of the vaccine in people ages 9 through 26 to prevent anal cancer and lesions caused by four types of the human papillomavirus — 6, 11, 16, and 18 — which are responsible for up to 90 percent of anal cancer cases.

Gardasil, manufactured by Merck and Co. Inc., was originally approved to prevent cervical, vulvar and vaginal cancer in girls and young women. It is also approved to prevent genital warts in both males and females.

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"Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research said in a statement.

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Agency officials based their decision in part on Merck clinical data that showed the vaccine could be up to 78 percent effective in preventing anal lesions and anal cancer in men who have sex with men. Because anal cancer is the same disease in both sexes, the data were used to support the expanded use of Gardasil in women as well.

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Anal cancer is rare, but the incidence is increasing. Nearly 5,300 people are diagnosed each year, and about 720 die, according to the National Cancer Institute. About 1.6 people per 100,000 develop anal cancer each year, with a slightly higher proportion of men to women.

However, the incidence is much higher among men who have sex with men. In that group, the rate jumps to about 40 cases per 100,000 men. If those men have HIV, the rate spikes to 80 per 100,000 cases.

Approval of an expanded use of Gardasil could influence whether the vaccine is recommended for use in boys and young men . The government Advisory Committee on Immunization Practices has been considering whether to recommend universal vaccination for young males as well as females.

Issues under consideration include whether to recommend vaccination for all young males, or whether to recommended targeted vaccination for boys and young men who may engage in sex with males.

Dr. James Turner, past president of the American College Health Association and a voting member of ACIP, supports universal vaccination. He approved the decision to expand the use of Gardasil.

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"I am not surprised, and am in total agreement with FDA's decision," said Turner, who said it's too soon to tell how the decision might affect discussions of HPV vaccine use in boys and men.

More than 65 million doses of Gardasil have been distributed worldwide since its approval in 2006 to prevent cervical cancer in girls and young women. Critics have worried about side effects from the vaccine. Most common adverse events have included fainting, pain at the injection site, headache, nausea and fever.

Gardasil's sales hit $1.1 billion last year, though the product has not reached initial expectations for even larger sales.

Merck is based in Whitehouse Station, N.J. Its shares rose 3 cents to $36.22 in afternoon trading.

The Associated Press and Reuters contributed to this story.

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