"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors. Any state or local government now beset by Merck’s lobbying campaigns to mandate this HPV vaccine for young girls ought to take a look at these adverse health reports."
-Tom Fitton
On June 8, 2006, the Food and Drug Administration (FDA) approved the drug Gardasil. Gardasil is a vaccine against certain types of human papillomavirus (HPV) which is the primary cause of cervical cancer in women.
- Several state and local governments have proposed requiring the vaccine for school girls entering the 6th grade.
- Gardasil is approved for girls as young as nine years old, despite the fact that the youngest girls participating in clinical trials were 11-12 years old.
- A recent study, published in the New England Journal of Medicine, also questioned the general effectiveness of Gardasil. Additionally, there has not been a chance to study long term side effects of the vaccine.
Judicial Watch, concerned about the rush to market and mandate a drug with possible serious adverse effects, filed its first Freedom of Information Act (FOIA) request on May 9, 2007, and received 1,637 adverse event reports on May 15, 2007. These reports are submitted to the Vaccine Adverse Event Reporting System (VAERS) and used by the FDA to monitor the safety of vaccines.
On August 20, 2007 Judicial Watch filed a request for updated adverse event reports and received 1,824 reports on September, 13 2007. Judicial Watch then filed a complaint against the FDA on October 3, 2007 for failing to fully respond to the May 9, 2007 FOIA request.
Judicial Watch has posted links to the adverse event reports below and continues to monitor VAERS reports submitted to the FDA in relation to Gardasil.
The case was closed in April 2010.
Special Reports
Documents Uncovered
- Vaccine Adverse Effects Report System (VAERS) serious effects report from May, 2009 to September, 2010 - September 28, 2009
- Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 16, 2009
- Vaccine Adverse Effects Report System (VAERS) serious effects report from May 1, 2008 to May 15, 2009 - May 15, 2009
- Vaccine Adverse Effects Report System (VAERS) serious effects report from January 1, 2008 to June 10, 2008- June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) reports on Guillane-Barre Syndrome, spontaneous abortions, and all life-threatening cases from 2008 - June 30, 2008
- Vaccine Adverse Effects Report System (VAERS) cumulative Gardasil adverse effects report (Warning, this is a very large file) - June 30, 2008
- Merck's application to the FDA to patent the Gardasil vaccine - February 22, 2008
- Merck's standard Gardasil information publication
- Merck's report to the FDA giving the details of Gardasil and its clinical test results - February 22, 2008
- A transcript of the Vaccines and Related Biological Products Advisory Committee's meeting to discuss Gardasil - February 22, 2008
- Document from the FDA giving a determination of Regulatory Review Period for Purposes of Patent Extension for Gardasil - February 22, 2008
- Gardasil Related Deaths Reported to VAERS as of September 7, 2007
- Gardasil Related Deaths Reported to VAERS as of May 11, 2007
- Vaccine Adverse Event Reporting System (VAERS) Reports as of September 7, 2007
- Vaccine Adverse Event Reporting System (VAERS) Reports as of May 11, 2007
Litigation Documents
Press Releases
News Stories, Reports and Informational Links
- New England Journal of Medicine
Guide to State Legislation About Mandatory HPV Vaccination
Article originally appeared on The Gary Null Blog (http://www.garynullblog.com/).
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