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Home HPV Vaccines HPV Vaccines Gardasil® Approved for Vulvar and Vaginal Cancers

Gardasil® Approved for Vulvar and Vaginal Cancers

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In September 2008, the Food and Drug Administration (FDA) expanded the indication of Merck’s cervical cancer vaccine, Gardasil®, to include prevention of vulvar and vaginal cancers. Gardasil approved for vulvar and vaginal cancers

Gardasil® was approved in 2006 for the prevention of cervical cancer, along with cervical, vaginal, and vulvar precancers. In clinical trials Gardasil® prevented nearly 100% of cervical diseases related to HPV 16 and 18, the “high risk” types that cause about 70% of cervical cancers worldwide.

More recent data show the vaccine has similar efficacy against vulvar and vaginal diseases: in a cohort of over 15,000 women, none of those in the vaccine group who were HPV 16/18-negative developed vulvar or vaginal precancers related to those types over 3-5 years of follow-up. In the placebo group, HPV 16/18 were found in 19 cases of vulvar precancers and 10 cases of vaginal precancers, respectively.

In a press release, FDA spokesperson Jesse L. Goodman, M.D., M.P.H., said, “There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer.”

The American Cancer Society estimates 3,460 cases of vulvar cancer occur each year in the U.S., and nearly 900 women die as a result. With vaginal cancer, ACS says the annual incidence is approximately 2,200 cases, of which 760 are fatal.  The diseases are most often found in women age 50 and older.

Research shows that Gardasil® is virtually 100% effective in blocking persistent infections and diseases related to the HPV types the vaccine covers. Gardasil® doesn’t protect against all HPV types, however, and healthcare providers and women’s health advocates alike agree it’s critical for women who receive the vaccine to have regular cervical cancer screening: this involves Pap tests and, when appropriate, HPV tests. Read more about cervical cancer screening at the ASHA website.