Last month, a Food and Drug Administration panel approved the use of Gardasil for males.  Gardasil, a vaccine created to prevent the sexually transmitted Human Papillomavirus (HPV), was approved for women under the age of 25 in 2006, and recently several states have moved to mandate the vaccine for young girls.  On September 9th, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel voted 7 - 1 in favor of approving Gardasil for males, and it is expected that the FDA will officially approve the decision shortly. 

HPV  is the most common sexually transmitted disease in the world.  While the majority of sexually active people have contracted HPV, very few will ever experience symptoms.  HPV can lead to cervical cancer in women, but in men the most common complaint is genital warts.  Although genital warts are contagious and can cause discomfort and embarrassment, they are usually not serious.  Also, according to a briefing document provided to the VRBPAC, only "~1% of all sexually active adults in the U.S." has genital warts.  Given the extremely low number of males who experience complications from HPV, it is worth questioning whether the vaccine is necessary for males at all.  The VRBPAC briefing document shows that Gardasil is only 67.2% effective for men, and for men who have been exposed to HPV, the efficacy rate is only 23.2%.  Another document provided to the VRBPAC revealed that in safety studies, "overall, 46.1% of male subjects who received Gardasil...reported one of more new onset medical conditions after Day 1."

As the FDA moves to approve Gardasil for males, other sources still question its safety for use in females.  According to the FDA's Clinical Review, released in September 2008, 85.9% of girls aged 9 -17 experienced adverse events after receiving the Gardasil vaccine.  92.5% of women aged 18 - 26 experience adverse events.  The percentage of patients with new medical conditions after receiving their first dose of Gardasil was 38.6%.  The report also found that "there was only an 18.4%...reduction of any HPV related CIN 2/3 in the entire study population."  CIN 2/3 are lesions that often lead to cervical cancer.  The study concluded that "it is not known the ultimate duration of immune response elicited by Gardasil, nor its long term safety." 

In addition to supplemental documents, the FDA and the Centers for Disease Control (CDC) have a reporting system put in place to monitor adverse reactions.  The Vaccine Adverse Event Reporting System (VAERS) tracks all adverse events reported in relation to Gardasil.  Judicial Watch routinely requests these reports using the Freedom of Information Act.  In the latest VAERS produced, Judicial Watch received reports from May 2009 to September 4, 2009, roughly a four month period.  In those four months:      

• 1510 adverse event reports were filed
• 19% were classified as "serious"
• 40 cases were life threatening
• 77 cases resulted in permanent disability

Also, 8 deaths were reported, making the total number of deaths connected to Gardasil vaccinations 55.  Given these numbers, one might ask why anyone would approve the vaccine, let alone mandate it.  However, the FDA and CDC continuously downplay the importance of VAERS data.

While some VAERS are filed by physicians and medical staff, in many cases a VAERS report must be submitted by the patient or a family member because a doctor or nurse refuses to fill out the form.  In those instances, the FDA has claimed that there is not "sufficient detail" to evaluate the cases.  This does not in any way imply that the adverse reactions in these reports are any less real, but instead raises a question:  Why do the FDA and CDC continue to use what they deem an unreliable system to collect their data?  Instead of dismissing the information that they collect, they ought to either reform the system or start analyzing information from every VAERS. 

Gardasil's safety is a growing concern.  The FDA has not done a thorough job of evaluating problems with the vaccine, despite issues raised by numerous scientists and concerned parents whose daughters have experienced adverse reactions.  At present, it is not known whether Gardasil is safe or effective in the long term.  As the FDA moves to approve Gardasil for males and more states begin to mandate the vaccine, the public ought to carefully examine the available data and determine whether Gardasil is worth the risk.  Judicial Watch has obtained thousands of documents on Gardasil.  All the information obtained from FDA documents, as well as Judicial Watch's special report and press releases, may be found at our Gardasil Investigation page. 

Documents

VAERS, May 2009 - September 2009

September 2009 VRBPAC Briefing Information

FDA Information on Gardasil