The HPV vaccine Gardasil® (quadrivalent human papillomavirus [types 6, 11, 16, 18] recombinant vaccine) was found to be safe, according to the results of a large safety study published in the Archives of Pediatrics & Adolescent Medicine. The study was required by the U.S. Food and Drug Administration (FDA) as follow-up to the drug’s 2006 approval.
Human papillomaviruses (HPV) consist of more than 100 different viruses. Some types of HPV cause warts on the hands or feet; others cause genital warts; and some have been linked with cancer, most notably cervical cancer.
Gardasil prevents infection with four types of HPV—types 6, 11, 16, and 18. HPV types 16 and 18 cause roughly 70% of all cases of cervical cancer, and HPV types 6 and 11 account for roughly 90% of genital warts. The FDA approved Gardasil in June 2006 for girls and women ages 9 to 26. The drug is now also approved for boys and men. Follow-up studies are the norm to evaluate side effects of drugs and vaccines.
In this study, researchers evaluated the medical records of 189,629 girls and women ages 9 to 26 within the Northern and Southern California Kaiser Permanente health care systems. All participants received at least one dose of Gardasil between 2006 and 2008 and by the end of the study period, 44,000 participants had received three doses of the vaccine.
The researchers examined the rate of emergency visits and hospitalizations in the two weeks following vaccination and again a couple months later. They found that the vaccine caused fainting on the day of the injection and skin infections two weeks later in some subjects, both of which are known short-term side effects of the vaccine. However, they concluded that the vaccine was not associated with serious health effects.
Although there were reports of seizures and allergic reactions, a five-member safety committee of medical experts concluded that these reactions were not related to the vaccine.
Overall, the safety experts determined that there were no safety concerns with the vaccine. They note that fainting is a common reaction to all vaccines.
Klein NP, Hansen J, Chao C, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Archives of Pediatrics & Adolescent Medicine. Published early online October 2012. doi:10.1001/archpediatrics.2012.1451.
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