GSK Applies For WHO Prequalification Of HPV Vaccine Cervarix

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 12 Oct 2007 - 1:00 PDT

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GlaxoSmithKline recently applied for World Health Organization prequalification review of its human papillomavirus vaccine Cervarix for by with the aim of expediting the drug's sale to women in developing countries, Business Daily Africa reports (Aron, Business Daily Africa, 10/9).

Cervarix has 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. Kenya in August became the third country after Australia and the United Arab Emirates to approve marketing of Cervarix (Kaiser Daily Women's Health Policy Report, 8/31). GSK earlier this month announced that the European Commission approved Cervarix for sale and marketing in the European Union (Kaiser Daily Women's Health Policy Report, 9/24).

According to some medical experts, WHO's approval is important to the success of GSK's plan to sell Cervarix at preferential prices in low-income countries through a "tiered pricing" program. Under the tiered pricing program, the company will enter into special purchase agreements with buyers -- including UNICEF and governments of developing countries -- to purchase the vaccine at a reduced price, Business Daily Africa reports. The company in a statement said the subsidies will be based on the buyer's national income, the number of doses ordered and the length of the contract. Products with prequalification status could be used by U.N. agencies, the GAVI Alliance and HPV vaccination programs worldwide, Business Daily Africa reports.

"GSK believes that people in developing countries should have rapid access to life-saving vaccine once they are approved," Jean Stephenne, president and general manager of GSK Biologicals, said. "Prequalification would help speed access to this important new tool for girls and women across the world at risk for cervical cancer," Nono Simelela of the International Planned Parenthood Federation said, adding, "Along with increased awareness and improvements in screening and treatment, cervical cancer vaccines will help save and improve the lives of millions of women" (Business Daily Africa, 10/9).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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