Kenya's Pharmacy And Poison Board Approves Marketing GlaxoSmithKline's HPV Vaccine Cervarix

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 05 Sep 2007 - 16:00 PDT

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GlaxoSmithKline's human papillomavirus vaccine Cervarix earlier this month became available in Kenya, shortly after the country's Pharmacy and Poison's Board approved it for marketing, Nicholas Muraguri, director of health promotion in the Ministry of Health, said, Kenya's Business Daily reports (Onyango/Kimani, Business Daily, 8/29).

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 (Kaiser Daily Women's Health Policy Report, 8/28). According to Business Daily, Kenya became the third country after Australia and the United Arab Emirates to approve marketing of Cervarix after the pharmacy board approved GSK's application on June 20.

Price, Competition from Merck
GSK has not yet determined the price of the vaccine in Kenya, but Muraguri said it costs about 20,000 shillings, or about $300. Muraguri added that many Kenyans will be unable to afford the vaccine and that the government "will be lobbying with health donors" to purchase bulk quantities of Cervarix. The Kenyan government does not have the authority to issue price controls for the vaccine, Business Daily reports.

William Mwatu, director of medical and regulatory affairs in East Africa for GSK, said the company is "investigating the cost and supply details of Cervarix" in Kenya, adding that GSK hopes to have a price within the next two months. He added that the "ideal situation" would be to vaccinate all Kenyan girls and women ages 10 to 55.

Merck's HPV vaccine Gardasil already is registered in Kenya and available commercially for 10,000 shillings, or about $150, Business Daily reports (Business Daily, 8/29). Gardasil has shown to be 100% effective in preventing infection with HPV strains 16 and 18 and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains (Kaiser Daily Women's Health Policy Report, 8/28). According to data released by the Kenya Medical Research Institute in December 2006, cervical cancer is the leading cause of death among women in the country (Business Daily, 8/29).

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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