E.U. Agency Will Not Change HPV Vaccine Gardasil Label

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 29 Jan 2008 - 9:00 PST

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The European Medicines Agency on Thursday said it would make no changes to the label of Merck's human papillomavirus vaccine Gardasil after two deaths were reported among women who received the vaccine, London's Times reports (Times, 1/25). The agency said no link between the deaths and the drug has been established. It added that an estimated 1.5 million women have been vaccinated in the European Union (Kahn/Jones, Reuters, 1/23).

Gardasil in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 1/7).

Forbes Examines Use of Pap, HPV Tests

In related news, Forbes on Monday examined use of HPV and Pap tests in the U.S. and worldwide, as well as the research and development activities of HPV test producer Digene and its parent company Qiagen. According to Forbes, the Pap test has been a "valuable" tool, but the 65-year-old test is "archaic" (Cain Miller, Forbes, 2/28). Digene's DNA Pap test -- which combines the traditional Pap test with a DNA test for 13 strains of HPV - has been approved by FDA as a primary screening tool for cervical cancer for women ages 30 and older, as well as for testing women with abnormal Pap test results (Daily Women's Health Policy Report, 10/19/07).

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