Gardasil, which targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer, is already approved to help prevent a leading cause of cervical cancer in women of that same age range. Two of those HPV strains can also cause some vulvar and vaginal cancers.
The HPV vaccine first gained Food and Drug Administration (FDA) approval in 2006 for use in girls and women aged 9-26 to help prevent cervical cancer, precancerous genital lesions, and genital warts. The CDC recommends Gardasil for all girls aged 11-12. Girls can get Gardasil when they're as young as 9. If they miss vaccination at ages 11-12, they can get vaccinated by age 26.
FDA also added on its website that that no vaccine is 100 percent effective and urged women to continue to receive routine screenings to detect possible cancer.
Market analysts believe that the FDA approval of Gardasil for the added uses may give Merck an advantage over Cervarix, a competing vaccine that GlaxoSmithKline Plc wants to bring to the U.S. market. The FDA delayed approval of Cervarix in December.
Vaginal and vulvar cancers account for about 1,760 deaths a year, according to the American Cancer Society. There are about 2,140 new cases of vaginal cancer and 3,490 of vulvar cancer annually.
