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Gardasil Declared Safe, Despite Side Effect Reports

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Even with side effect reports nearing 10,000, the Food & Drug Administration (FDA) and Centers for Disease Control (CDC) are still standing by Gardasil. Earlier this month, the FDA and Merck announced that the prescribing information for Gardasil was being updated to include warnings about some of the more minor reactions seen after the vaccine, including joint and muscle pain, fatigue, physical weakness and general malaise. At the time, FDA spokeswoman Karen Riley told The Washington Times that the label updates have “nothing to do with” the serious cases that have been reported. She said the updates were made at Merck’s request and touch on possible “mild” symptoms.

As of June 30, 2008, there have been 9,749 Vaccine Adverse Event Reporting System (VAERS) reports of adverse events following Gardasil vaccination. Of these, 6 percent were deemed serious. The adverse event reports included 20 deaths, as well as reports of a rare neurological condition called Guillain-Barré Syndrome.

Despite these disturbing reports, the FDA and CDC are standing by Gardasil. “There was not a common pattern to the deaths that would suggest they were caused by the vaccine,” the FDA and CDC said in a statement.

Regarding other serious problems reported in relation to Gardasil, the CDC and FDA claimed the data “do not currently suggest an association” between Gardasil and the conditions.

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 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.

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