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European Regulators Report 2 Deaths After Gardasil

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Two young women in Europe have died after receiving Gardasil, bringing the total number of known deaths following administration of the HPV vaccine to 5. In the U.S., three young women have reportedly died after receiving Gardasil. However, there could be more such incidents, as health officials believe that adverse effects of medication are widely underreported.

Though no cause of death has yet been listed, the European Medicines Agency (EMEA) says the young women died shortly after receiving Gardasil. The EMEA is characterizing their deaths as “sudden and unexpected.”

Gardasil was approved by the U.S. Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of HPV that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.

Just weeks after its approval, the U.S. Centers for Disease Control (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities to make Gardasil vaccinations mandatory for young girls. Merck has made similar efforts in Europe. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.

However, many critics have opposed moves to make Gardasil mandatory, and contend the safety of the vaccine has yet to be proven. In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory. In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.

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