HPV Vaccine Cervarix Approved In Australia, GSK Says

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Pediatrics / Children's Health;  Women's Health / Gynecology
Article Date: 24 May 2007 - 6:00 PST

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GlaxoSmithKline on Monday announced that the Australian Therapeutic Goods Administration has approved its human papillomavirus vaccine Cervarix for girls and women ages 10 to 45, Reuters reports (Potter/Hirschler, Reuters, 5/21). According to Dow Jones, the approval is the first "major market" license for Cervarix. GSK also has applied for approval of the vaccine in the U.S. and Europe (Berton, Dow Jones, 5/21).

Cervarix and Merck's HPV vaccine Gardasil have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. Researchers in a 2006 study published in the online edition of the Lancet also found that Cervarix prevented infection with HPV strains 31 and 45, which together with strains 16 and 18 cause more than 80% of cervical cancer cases. GSK in January announced that it would begin a trial to determine whether Cervarix provides better protection against cervical cancer than Gardasil (Kaiser Daily Women's Health Policy Report, 4/24).

"The approval of Cervarix in Australia is a key milestone towards eradicating the burden of cervical cancer for all women, especially as this is the first cervical cancer vaccine that is explicitly indicated anywhere in the world for women over the age of 26," Jean Stephenne, president of GlaxoSmithKline Biologicals, said (GSK release, 5/21). According to GSK, older women who already have HPV also could benefit from the vaccine because they are still at risk of contracting different strains. The company has applied to Australia's Pharmaceutical Benefits Advisory Council to include Cervarix on the national immunization list (Kaiser Daily Women's Health Policy Report, 4/24).

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