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28 Deaths Tied To Gardasil, Watchdog Says

Vaccine Meant To Prevent HPV Infections, Cervical Cancer

POSTED: Wednesday, June 24, 2009

Twenty-eight girls and women died in 2008 soon after taking Gardasil, a vaccine meant to prevent human papillomavirus infections and fight cervical cancer, according to a group that analyzed FDA records.

Judicial Watch, which said it investigates and prosecutes government corruption, said in a news release there have been 47 deaths associated with Gardasil since it was approved in 1996.

The results were taken from the FDA's Vaccine Adverse Event Reporting system, which also noted more than 6,700 adverse events in 2008.

A news release from the group did not say how many people had taken the vaccine, which is given as a series of three shots.

The FDA said on a Gardasil information page that it monitors the system but still feels that the benefits of the vaccine outweigh the risks.

It also notes that there has been no common pattern in the deaths and adverse reactions that can be traced to the vaccine. It said that in many cases, the deaths were explained by other factors.

"Given the large number of vaccine doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in a large population during the time period following vaccinations," the site says.

Gardasil's maker, Merck, has distributed more than 16 million doses of Gardasil, the FDA says.

Judicial Watch noted incidents including a patient who developed cervical cancer 15 months after taking the vaccine, along with warts and miscarriages in pregnant women.

It also said there has been a pattern of cases of Guillain-Barre syndrome, a rare neurological disorder that causes muscle weakness. And the group says that of the 47 reported deaths, 41 occurred within a month of receiving the vaccine.

The group recommended against requiring girls to take the vaccine, as some locations have considered. A requirement for all school-age girls to take the vaccine in Texas was rejected by the state's Legislature in 2007.

Neither Merck's Web site nor a site for Gardasil have a statement reacting to the issue.
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