Two European Deaths Thought to Be Associated with HPV Vaccine

Mon Jan 28, 2008 - 12:15 pm EST

By Hilary White

January 28, 2008 ( - Two women have died shortly after receiving the new vaccine for human papilloma virus (HPV) that is being used in massive vaccination programmes in Europe. The European Medicines Agency (EMEA) did not disclose the women’s names, but has reported that the deaths occurred in Austria and Germany.

The agency, which acts as the European Union drug overseer, maintains that "benefits of Gardasil continue to outweigh its risks and that no changes to its product information are necessary." An estimated 1.5 million women have already been vaccinated with the drug in Europe, the agency said.

"No causal relationship has been established between the deaths of the young women and the administration of Gardasil," the EMEA statement said.

The drug that will be distributed in mandatory public health programmes in Britain has been implicated in the deaths of three women in the US. Marketed by the pharmaceutical giant Merck Frosst, Gardasil is a vaccine against HPV, the sexually transmitted infection that is known to cause most cases of cervical cancer.

Gardasil’s approval by the US Food and Drug Administration was based on the testing of only a few thousand patients, only a small portion of whom (1200) were young girls, aged 9-13 years. This age, group, however, is now being specifically targeted for mandatory vaccination programmes, including one by the province of Ontario.

The group Judicial Watch reported last year on the deaths of three US women related to the vaccine. One physician’s assistant reported that a female patient "died of a blood clot three hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19, reported deaths relating to heart problems and/or blood clotting.

In the US, the company dropped its lobbying efforts to have the drug used in nation-wide immunization programmes after opposition grew from medical groups.

Side effects published by Merck & Co. warn the public about potential pain, fever, nausea, dizziness and itching after receiving the vaccine. Other more serious side effects reported include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.

The US National Vaccine Information Center (NVIC) warned last year that "Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials."

NVIC president Barbara Loe Fisher said in February 2007, "Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls."

Read related coverage:

Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine

Merck Drug Company Drops Campaign for Mandatory HPV Vaccine

Support for HPV Vaccine Gardasil Helps Planned Parenthood Says LDI President

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