The FDA has approved Merck's cervical cancer vaccine Gardasil, the first vaccine approved to treat cervical cancers and other diseases caused by the human papillomavirus (HPV).
The agency approved Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) for use in 9- to 26-year-old females to prevent cervical cancer, cervical precancers, vulvar precancers and vaginal precancers caused by HPV types 16 and 18. It is also FDA-approved to prevent genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18. An FDA advisory committee recommended approval of Gardasil in May.
HPV Types 16 and 18 account for 70 percent of cervical cancers. Nearly half a million women develop cervical cancer every year and more than half of them die as a result, according to the World Health Organization. Clinical trials Merck released in October 2005 showed Gardasil prevented virtually 100 percent of HPV-caused growths that can lead to the deadly disease.
