FDA panel OKs HPV vaccine

NEWS IN BRIEF — Posted June 5, 2006

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A Food and Drug Administration advisory panel voted unanimously May 18 to recommend that the agency approve a vaccine to prevent four strains of the human papillomavirus that can cause cervical cancer and genital warts.

The panel found that the vaccine, Gardasil, would be safe and effective for girls and women ages 9 to 26. In clinical trials, the vaccine was found to be 100% effective in preventing infection with HPV strains 16 and 18 which cause about 70% of cervical cancer cases. The vaccine, given in three injections over six months, was also 99% effective in preventing HPV strains 6 and 11, which cause genital warts, according to the trial results.

If the vaccine receives FDA approval, it also must be examined by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, which makes recommendations on vaccine use. States will make the final decisions as to who should receive the vaccine -- the first to prevent HPV.

Cervical cancer currently causes 3,500 deaths among women in the United States each year and about 290,000 deaths worldwide. And since the vaccine is not 100% effective against HPV, it would not eliminate the need for cervical cancer screenings, including Pap tests.

Manufacturer Merck & Co. also asked that the advisory committee consider recommending its vaccine for use in boys to prevent genital warts, but the panel declined to vote on that question.

Note: This item originally appeared at

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