By Susan Brinkmann, OCDS
A new cervical cancer vaccine, dubbed the “promiscuity jab” in the UK, is responsible for more than 2,000 complaints since the government began administering it to teens last year. The same drug is currently under consideration by the Food and Drug Adminstration (FDA) for use in the U.S.
Cervarix, manufactured by GlaxoSmithKline, competes with Merck’s more expensive Gardasil vaccine in the UK where more than a million teens have already received it as part of a government program. The new drug, which is administered in three doses, targets two HPV strains that cause cervical cancer – HPV 16 and HPV 18.
But after a year of use, the track record for Cervarix does not appear to be much better than the problem-strewn Gardasil.
An analysis drawn up this month by the UK’s drug safety watchdog group, Medicines and Health care products Regulatory Agency (MHRA), found 2,107 patients who reported some kind of adverse reaction to the vaccine, including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total.
“We have spoken to parents whose daughters have had seizures, paralysis, blurred vision, severe headaches and the loss of feeling in parts of their body,” said Jackie Fletcher, founder of Jabs, a support group for families with children who became ill after vaccination, to London’s Telegraph.
“Doctors will try to convince parents that these problems are in their child’s mind, or have nothing to do with the vaccines, but we don’t think there is sufficient evidence to show Cervarix is safe.”
One girl, Stacey Jones, 17, began to suffer epileptic seizures within four days of her third injection of Cervarix this past March. She has since been diagnosed with a brain injury caused by inflammation of the brain and is currently receiving rehabilitation just to perform basic tasks such as making a sandwich.
Thus far, the family has received no explanation for what happened to their daughter and believe she was used as a guinea pig for the new drug.
However, a spokesman for GlaxoSmithKline said more than 70,000 doses of the drug were used in trials before a license was granted. “The UK medicines safety agency has reviewed all reported adverse events relevant to Cervarix and there is no evidence to suggest that the vaccine carries any long-term side effects,” he said.
Merck says much the same thing about its version of the vaccine, Gardasil, introduced in 2006. As of July, 2009, the Vaccine Adverse Event Reporting System (VAERS) has received more than 15,000 reports of reactions to the vaccine, including more than 3,000 injuries and 48 deaths. Despite the ever-increasing number of reports, Merck has consistently maintained that “no safety issue related to the vaccine has been identified.”
The UK government plans to continue administering Cervarix to girls as they enter their teens, as well as to older girls, with the goal of having all females below the age of 18 vaccinated by 2011.
Cervarix has been under consideration for several years by the FDA for use in girls ages 10 to 25 and is expected to be approved at any time.
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