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One-Quarter of U.S. Girls Receive Controversial Gardasil Vaccine

Oct 10, 2008 | Parker Waichman LLP

Federal authorities report that about 25 percent, or one-quarter, of U.S. teenage girls have received the cervical cancer vaccine Gardasil in its first full year of distribution.  The figures represent the government's first substantial study of Gardasil vaccination rates.  Gardasil is Merck and Company's heavily advertised, three-shot vaccination series that targets the sexually transmitted human papillomavirus, or HPV.

Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts.  "For a new vaccine, 25 percent is really very good," Lance Rodewald, director of the division of immunization services at the Centers for Disease Control and Prevention (CDC) said.  "We need to see that rate every year if we are going to meet our goal" of having 90 percent of teenagers vaccinated, he added.  But immunologist W. Martin Kast, of the University of Southern California's Keck School of Medicine, said, "Twenty-five percent is not bad, but it's not good either."  Last May, the U.S. Centers for Disease Control and Prevention (CDC) said Gardasil is linked with a higher risk of fainting.

The vaccine has been criticized by scientists who say it is only modestly effective and its safety has not been adequately proved; conservative groups who say that giving it to young girls implies approval of sexual activity; and consumer advocates who say its price, $360 for a series of three shots, is prohibitive.  Meanwhile, we reported on a group of Australian researchers who found that young women there who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer rare and severe allergic reaction versus other girls who received other vaccines in comparable school-based vaccination programs.

In July, Gardasil was criticized for possible links to a 20-year-old woman who suffered a stroke after receiving a second Gardasil injection.  In June, Merck added more possible adverse reactions to Gardasil’s growing list, including fatigue, weakness, and muscle pain.  Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released by watchdog group Judicial Watch.  We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered.  A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure.  Recently, a 13-year-old, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; she is now almost completely paralyzed.

U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems.  Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.


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