Australia's Therapeutic Goods Administration Recommends Cervarix Approval, GSK Plans To Launch Vaccine Sales Within Months

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology;  Pediatrics / Children's Health
Article Date: 26 Apr 2007 - 6:00 PDT

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The Australian Therapeutic Goods Administration's drug evaluation committee has recommended that the Australian Department of Health and Ageing approve GlaxoSmithKline's experimental human papillomavirus vaccine Cervarix for girls and women ages 10 to 45, the West Australian reports (O'Leary, West Australian, 4/21). 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. According to Merck, Gardasil is about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases. Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that are linked to HPV, according to a study presented in June 2006 at a meeting of the American Society of Clinical Oncology in Atlanta (Kaiser Daily Women's Health Policy Report, 3/30). According to a GSK spokesperson, the company is finalizing information for Cervarix and plans to launch the vaccine within a few months (West Australian, 4/21). GSK also has applied to Australia's Pharmaceutical Benefits Advisory Council to include Cervarix on the national immunization list, Australia's Courier & Mail reports. According to GSK, older women who already have HPV could benefit from the vaccine because they are still at risk of contracting different strains, according to the Courier & Mail (Courier & Mail, 4/21).

Teen Girls Begin Receiving Gardasil at No Cost
Teenage girls in the country earlier this month began receiving Gardasil at no cost as part of a four-year immunization program, according to the West Australian (West Australian, 4/21). The Therapeutic Goods Administration in June 2006 approved Gardasil for girls and women ages nine to 26 and boys ages nine to 15. Prime Minister John Howard in November 2006 announced that the government will provide about $342 million for a program that will offer Gardasil at no cost to girls and women ages 12 to 26. Australia's National Immunisation Program aims to vaccinate female students ages 12 to 18, and women ages 18 to 26 will be able to receive the vaccination at no cost from their general practitioner for two years beginning in the middle of 2007 (Kaiser Daily Women's Health Policy Report, 11/30/06).

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