Gardasil Effective In Preventing Vaginal, Vulvar Cancers, Study Finds

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 22 May 2007 - 3:00 PDT

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Merck's human papillomavirus vaccine Gardasil is effective in preventing vaginal and vulvar tumors, according to a study to be published on Saturday in the journal Lancet, Dow Jones reports (Berton, Dow Jones, 5/17).

Gardasil in clinical trials has been shown to be 100% effective in preventing infection with strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains. FDA in June 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine, which is given in a three-shot series (Kaiser Daily Women's Health Policy Report, 5/15). Merck last month announced that it has submitted an application to FDA for extended approval of Gardasil to help prevent vaginal and vulvar cancers.

Study Details
Initial data from the study were presented at a June 2006 meeting of the American Society of Clinical Oncology. Jorma Paavonen of the University of Helsinki and colleagues randomly assigned 18,000 women to receive the Gardasil or a placebo (Kaiser Daily Women's Health Policy Report, 4/18). The study, which was funded by Merck, was conducted among girls and women ages 16 to 26 in 24 countries worldwide (HealthDay News/Forbes, 5/17).

After three years of follow-up, the study found that the vaccine was 71% effective in preventing vaginal and vulvar cancers related to HPV strains 16 and 18 among women who previously had been exposed to HPV strains 6, 11, 16 and 18. It was 100% effective among women who previously had not been exposed to those strains (Merck release, 5/17). The vaccine was not effective in fighting vaginal or vulvar lesions that had already formed, according to the study (Pensa, South Florida Sun-Sentinel, 5/18).

According to Merck, vaginal and vulvar cancers account for about 3% and 4% of gynecological cancers, respectively (Kaiser Daily Women's Health Policy Report, 4/18). According to HealthDay News/Forbes, HPV is present in about 80% of the 6,000 vaginal and vulvar cancers diagnosed annually in the U.S. (HealthDay News/Forbes, 5/17).

An abstract of the study is available online.

NPR's "Talk of the Nation" on Friday in the first hour of the program is scheduled to include a discussion about HPV vaccine research. The scheduled guest for the program is James Colgrove, an author and assistant professor of sociomedical sciences at Columbia University's Mailman School of Public Health ("Talk of the Nation," NPR, 5/18). Additional information about the segment is available online. Broadcast schedules also are available online.

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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