FDA Approves Two HPV Vaccines: Cervarix for Girls, Gardasil for Boys
October 20, 2009- Bethesda, Maryland- The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine's manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months.
Cervarix is a bivalent vaccine, meaning it is specifically designed to protect against two human papillomavirus (HPV) types, HPV 16 and 18, which together are responsible for three-quarters of cervical cancers in North America. Clinical trial data also indicate that Cervarix offers more modest protection against precancerous lesions associated with HPV 31, GSK explained in a statement, as well as other tumor-causing (or oncogenic) HPV types. The company expects the vaccine to be available in the United States by the end of the year.
The FDA last week also approved the HPV vaccine Gardasil for the prevention of genital warts in boys. Gardasil is already approved and is being actively used in girls and young women for the prevention of cervical cancer.
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