Gardasil Paralysis and Adverse Events

Washington, DC: The numbers are staggering. Less than two years after the approval of Gardasil, the much touted vaccine supposed to prevent cervical cancer in young women, several deaths and thousands of cases of adverse effects have been reported. [ Read More ]

On July 7, 2008 CNN News reported that the Center for Disease Control and Prevention (CDC) had received 7,802 "adverse event" reports since Gardasil was approved, including reports of paralysis and death. According to CNN, 15 deaths were reported to the FDA, and 10 were confirmed, but so far, none of the 10 confirmed deaths have been directly linked to the vaccine. The CDC is currently investigating reports of illness.

In June 2006, Gardasil became the only approved vaccine to prevent cervical cancer, precancerous or dysplastic lesions and genital warts caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18 in girls and women nine through 26 years of age. At that time, Merck claimed their clinical trials had proven the vaccine to be between 90-100 percent effective in preventing the transmission of some strains of HPV that cause cervical cancer, and it even claimed that Gardasil had the "potential to eventually eliminate most cervical cancers". (According to the CDC, Gardasil has been tested in more than 11,000 females 9 to 26 years of age in many countries around the world, including the US.)

However, some experts say the vaccine has not been subjected to enough testing to ensure its safety and there has not been enough post-marketing surveillance of Gardasil to ensure it is free of side effects that could prove particularly dangerous to young girls.

The Vaccine Adverse Event Reporting System (VAERS), managed by the CDC, is a national program that monitors the safety of vaccines after they are licensed. Just over a year ago, VAERS reported a total of 2,531 reports regarding Gardasil, of which nearly 95 percent were classified as non-serious. However, it also reported seven deaths after the vaccine was administered.

HPV (human papillomavirus) is a sexually transmitted virus. The FDA reports that at least 50 percent of people who have had sex will have HPV at some time in their lives. Since its approval, Merck & Co. Inc. says it has distributed more than 26 million Gardasil vaccines worldwide, including nearly 16 million in the US. Also known as Silgard, it has been approved in 103 countries, and Merck is pushing for additional applications to be approved with regulatory agencies in many more countries.