Inpharma 1575 - 17 Feb 2007 Quadrivalent recombinant HPV vaccine: safety concerns The National Vaccine Information Center (NVIC), the leading vaccine safety and informed consent advocacy organisation in the US, is pressing for state legislatures to investigate the safety and cost of introducing Merck’s human papillomavirus (HPV) vaccine recombinant quadrivalent [Gardasil] for all pre-adolescent girls prior to introducing changes to state vaccine laws. In an analysis of reports made to the federal Vaccine Adverse Event Reporting System (VAERS) since the recommendation * for universal use of Gardasil for all young girls in July 2006, NVIC found reports of loss of consciousness, joint pain, seizures and Guillain Barre syndrome. Between July 2006 and January 2007, 82 reports of adverse events have been filed with VAERS following the administration of Gardasil to girls and boys aged 11–27 years. In all but three reports, the adverse event occurred within 1 week of vaccination, and over 60% of adverse events occurred within 24 hours of vaccination. The reports also indicate that Gardasil is being administered to girls and women concomitantly with a number of different vaccines, despite the product’s insert stating that, with the exception of the hepatitis B vaccine, the coadministration of Gardasil with other vaccines has not been studied. Currently, there is no publicly available information regarding the number of girls aged 9–15 years who received Gardasil and the hepatitis B vaccine in pre-licensure clinical trials. * by the US Centers for Disease Control and Prevention National Vaccine Information Center. HPV Vaccine Mandates Risky and Expensive. Media Release : 1 Feb 2007. Available from: URL: http:// www.nvic.org 809072091 1 Inpharma 17 Feb 2007 No. 1575 1173-8324/10/1575-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Quadrivalent recombinant HPV vaccine: safety concerns

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Inpharma 1575 - 17 Feb 2007

Quadrivalent recombinant HPVvaccine: safety concerns

The National Vaccine Information Center (NVIC), theleading vaccine safety and informed consent advocacyorganisation in the US, is pressing for state legislaturesto investigate the safety and cost of introducing Merck’shuman papillomavirus (HPV) vaccine recombinantquadrivalent [Gardasil] for all pre-adolescent girls priorto introducing changes to state vaccine laws.

In an analysis of reports made to the federal VaccineAdverse Event Reporting System (VAERS) since therecommendation* for universal use of Gardasil for allyoung girls in July 2006, NVIC found reports of loss ofconsciousness, joint pain, seizures and Guillain Barresyndrome.

Between July 2006 and January 2007, 82 reports ofadverse events have been filed with VAERS following theadministration of Gardasil to girls and boys aged11–27 years. In all but three reports, the adverse eventoccurred within 1 week of vaccination, and over 60% ofadverse events occurred within 24 hours of vaccination.The reports also indicate that Gardasil is beingadministered to girls and women concomitantly with anumber of different vaccines, despite the product’sinsert stating that, with the exception of the hepatitis Bvaccine, the coadministration of Gardasil with othervaccines has not been studied. Currently, there is nopublicly available information regarding the number ofgirls aged 9–15 years who received Gardasil and thehepatitis B vaccine in pre-licensure clinical trials.* by the US Centers for Disease Control and Prevention

National Vaccine Information Center. HPV Vaccine Mandates Risky andExpensive. Media Release : 1 Feb 2007. Available from: URL: http://www.nvic.org 809072091