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Apr 25, 2008 7:24 pm US/Eastern
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CBS4 I-Team: Vaccine Concern Part 2
MIAMI (CBS4) ―
The Gardasil television commercial is a popular one which markets a vaccine that is considered a major breakthrough in a fight the U.S. federal government is convinced can prevent cervical cancer. Within weeks of approval by the FDA, the Centers for Disease Control immediately recommended it for every 11 and 12-year-old girl.
Christina Bell, like many mothers, found her pediatrician recommending it for her daughter.
CBS4 Chief Investigative Reporter Michele Gillen asked Bell if it seemed like a no-brainer.
"I thought so," Bell told Gillen.
However, Bell says she now finds herself on a search for answers as to what happened to her daughter, Brittney, just weeks following an injection of Gardasil and a tetanus shot. The former cheerleader and runner's left leg was mysteriously affected by paralysis. The family wants to know if the condition could have been triggered by the vaccines she received that day.
Reported adverse events following vaccine injections, including Gardasil, have come under increasing scrutiny by parents reviewing them on the U.S. Vaccine Adverse Event Reporting System (VAERS).
"I think it's a marvelous addition to the scope of therapy I can offer kids," said Dr. Lorena Siqueira, Director of Adolescent Medicine at Miami Children's Hospital.
She says she believes the vaccine is safe and well worth prescribing for adolescents.
"Fortunately, I have no reports of serious reactions. I have seen occasional fainting episodes," Dr. Siqueira told Gillen.
Dr. Siqueira says she believes the fainting episodes are not tied to just the Gardasil vaccine but is the reaction of certain adolescents to an injection. Because of concerns over some girls who have reportedly fainted and injured themselves falling, the National Vaccine Information Center recommends that girls receive the shot lying down and that they be observed for 15 minutes after the injection.
"Brittany's case is at a quandary," said Sean Cronin, attorney for the Bell family.
Cronin says it is an uphill battle trying to investigate whether the Gardasil shot played any role in what has happened to Brittney. Christina Bell says Brittney's pediatrician does not believe there is a link.
Now the Bell family has learned that Merck can't be sued over its Gardasil vaccine because it has been added to a federal list of vaccines recommended by the government. The vaccine manufacturers are insulated from liability.
It's a fact many parents, and even some doctors, may not be aware of.
"You can't sue Merck over Gardasil," Gillen told Dr. Siqueira. She replied, "It's because vaccines are protected."
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Statement from Merck regarding the GARDASIL vaccine:
Merck actively monitors adverse event databases throughout the world, including the U.S. Vaccine Adverse Event Reporting System (VAERS). An event report does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination.
The labeling for GARDASIL reflects the extensive data available from our clinical trials. The data, including safety information, have been thoroughly reviewed and discussed by medical experts.
Since its FDA approval in June 2006 through March 31, 2008, Merck has distributed more than 26 million doses of GARDASIL worldwide.
Merck will continue to evaluate all reports in the context of our own post-marketing adverse experience database and our clinical trial database. Post-marketing adverse event reports received by the Company are sent to regulatory authorities worldwide in accordance with regulatory requirements, and Merck updates its product labels with new safety information as appropriate.
Merck encourages healthcare providers and consumers to report any potential adverse experiences following vaccination with GARDASIL to the Company and to adverse event reporting systems.
(© MMVIII, CBS Broadcasting Inc. All Rights Reserved.)