HPV vaccine Gardasil approved for sale in EU

Sep 26 2006

The European Commission on Friday approved Merck's human papillomavirus vaccine Gardasil for sale and marketing in the European Union, London's Guardian reports (Batty, Guardian, 9/22).

FDA in July approved Gardasil for sale and marketing to girls and women ages nine to 26.

According to Merck, the vaccine -- which is given in three injections over six months and costs $360 -- in clinical trials has been shown to be 100% effective in preventing HPV infection with strains 16 and 18, which together cause about 70% of cervical cancer cases, in women who do not already have the virus, 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.

Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that are linked to HPV, according to a study presented in June at a meeting of the American Society of Clinical Oncology in Atlanta (Kaiser Daily Women's Health Policy Report, 9/22).

Gardasil will be sold in the E.U. by Sanofi Pasteur, a joint company of Merck and Sanofi-Aventis. Sanofi Pasteur President Didier Hoch said the company will begin selling the drug in a European country by the end of next month (Reuters, 9/22).

In the United Kingdom, the Joint Committee on Vaccination and Immunisation, an independent advisory committee for the U.K. Department of Health, will decide if the vaccine will be covered by the National Health System (Daily Mail, 9/22).

A U.K. heath department spokesperson said the JCVI later this year will have meetings to review the vaccine's safety, efficacy and benefits, adding, "No decisions will be taken until the main JVCI present their recommendations to ministers for consideration" (BBC News, 9/22).