Gardasil Side Effect Reports Near 8000Jul 8, 2008 | Parker Waichman LLP
Nearly 8,000 adverse events associated with Gardasil were reported to the Centers for Disease Control (CDC) since June of 2006, further igniting concerns about the controversial vaccine's safety. While the majority of the reports involved complaints about pain and swelling at the injection site, at least 7 percent were more serious, and included reports of paralysis and deaths.
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.
According to the CDC, there were 7802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national program of the CDC and the FDA that monitors the safety of vaccines after they are licensed. VAERS receives reports of adverse events that occur after people receive vaccines.
According to the CDC, VAERS received 15 reports of death following Gardasil vaccination in the US. The CDC says it has not been able to establish a link between Gardasil and 10 of the deaths. The agency did not have enough information about the remaining five to make any determination.
According to the CDC, while Gardasil was being tested in the US before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.
VAERS also received 31 reports of Guillain-Barré Syndrome (GBS), an illness that leads to temporary, but often total body paralysis, after Gardasil vaccination in the US. Ten of those cases have been confirmed, five of which occurred when Gardasil was administered with another vaccine.
In a statement, Merck insisted that an adverse event report "does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination." Merck said it would continue to evaluate reports of adverse reactions. It said it "updates product labels with new safety information as appropriate."