July 25, 2008 FDA and CDC Continue to Find Gardasil A Safe and Effective Vaccine Responding to concerns raised by consumers, health professionals and parents about the vaccine Gardasil, the Food and Drug Administration (FDA) and the Centers For Disease Control and Prevention (CDC) jointly released a statement, on July 22, 2008, reporting that they continue to find the vaccine safe and effective. The FDA approved Gardasil in June 2006 for use in girls and women 9 to 26 years of age to prevent infection with the human papillomavirus (HPV) that causes most types of cervical cancer and genital warts. The FDA and CDC monitor vaccine safety through the Vaccine Adverse Event Reporting System (VAERS). VAERS tracks unconfirmed reports of adverse events associated with the administration of all vaccines licensed in the U.S. Since Gardasil’s release, 94% of the adverse events reported to VAERS have been non-serious events such as fainting, pain at the vaccine injection site, headache, nausea and fever. Upon further analysis of the 6% of reported adverse events, (9, 749 in total) including reports of Guillain-Barre Syndrome (a rare neurological disorder causing muscle weakness), blood clots, and 20 deaths, the FDA and CDC found that there is no common pattern amongst the events to suggest there is an association between the adverse event and the vaccine administration. Both the FDA and CDC commit to continue close monitoring of all events through VAERS and two other systems the CDC uses to monitor vaccine safety. Additionally, Merck, Gardasil’s manufacturer, has pledged to conduct a large postmarketing study to further assess vaccine safety. For more information please read the release at either the FDA http://www.fda.gov/cber/safety/gardasil071408.htm or CDC http://www.cdc.gov/vaccinesafety/ websites. |
