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.
