September 2011 – SANE Vax Inc, a consumer group advocating for vaccine safety, has notified the US FDA that thirteen vials of the Gardasil HPV4 vaccine currently on the market worldwide have been found contaminated with recombinant HPV DNA. Of concern is that this hitherto unknown contaminant may have triggered some of the autoimmune disorders, malignant tumors, and joint and central nervous system inflammation which have arisen in children and young women following their Garadsil™ vaccinations.
The vials tested all came from different lot numbers of the vaccine and were sourced from New Zealand, Australia, Spain, Poland, France and three states in the U.S. All the vials tested positive for the presence of the genetically modified HPV DNA.
SANE Vax contracted Dr. Sin Hang Lee to analyze the vaccine samples after a request for help by the mother of a young girl who’d developed the autoimmune disease, acute onset Juvenile Rheumatoid Arthritis, within 24 hours of her third injection of Gardasil™. Toxicity tests had found HPV DNA in the girl’s blood two years after that injection – a highly significant finding as it’s unusual to find HPV DNA in the blood. HPV (human papillomavirus) normally exists on the skin and mucous membranes and does not survive for any length of time in the bloodstream.
Dr. Lee, a pathologist at Milford Hospital pathology laboratory, a lab which uses the most advanced DNA sequencing techniques for molecular diagnoses, had this to say: “Natural HPV DNA does not remain in the bloodstream for very long. However, the HPV DNA in Gardasil™ is not ‘natural’ DNA. It is a recombinant HPV DNA (rDNA) – genetically engineered – to be inserted into yeast cells for VLP (virus-like-particle) protein production. rDNA is known to behave differently from natural DNA. It may enter a human cell, especially in an inflammatory lesion caused by the effects of the aluminum adjuvant, via poorly understood mechanisms….Once a segment of recombinant DNA is inserted into a human cell, the consequences are hard to predict. It may be in the cell temporarily or stay there forever, with or without causing a mutation. Now the host cell contains human DNA as well as genetically engineered viral DNA.” SANE Vax emphasizes that, “All recombinant or genetically engineered DNAs are considered potential biohazards if injected intramuscularly into the body. Merck’s Gardasil™ HPV4 vaccine is administered intramuscularly – as are many other vaccines.” (emphasis ours)
Since its US launch in 2006, Canadian in 2007, children have suffered catastrophic injuries including death following vaccination with Merck’s Gardasil vaccine, and GlaxoSmithKline’s Cervarix HPV vaccine. Some of their parents have launched websites to warn other families that the risks may far outweigh any potential benefit claimed by the manufacturers and health agencies who promote them. A Google search with the words “Gardasil dangers” brings up hundreds of articles discussing side effects and injuries linked to these vaccines. In the September 2008 FDA Closing Statement on Gardasil™ it was noted that 73.3% of girls in the clinical trials developed “new medical conditions” post vaccination and 17 girls died during them. Despite this, in February 2010 Health Canada approved use of Gardasil® for boys and men aged 9-26 years for prevention of infection caused by HPV types 6, 11, 16, and 18. And, again – despite the April 2011 US FDA’s rejection of Merck’s fourth application to extend its Gardasil™ licence to use in US women ages 27-45 – that same month, a Merck press release announced Health Canada had approved Gardasil® for use in Canadian women up to age 45.
According to Sane Vax Inc, the FDA’s rejection coincided with the removal of a statement in the Gardasil™ Patient Product Insert that the vaccine contained “no viral DNA”. But Medpage Today only reported that, “The decision was based on a trial in 3,253 women ages 27 to 45. Although the vaccine appeared to prevent persistent HPV infection, no significant benefit was found for more important outcomes such as high-grade neoplastic lesions or cervical cancer when all participants were included irrespective of baseline HPV status.”
- SANE Vax Letter to FDA
- Entire SANE Vax report
- Policy on the use of biohazardous agents and recombinant DNA in research and teaching laboratories at the University of North Carolina at Greensboro; Sept 24, 2008
- VRAN’s HPV vaccine page
- Global concerns about HPV vaccines; SANE Vax Inc; 2011
- Gardasil™ Patient Product Insert
- FDA Rejects Licensure of Gardasil vaccine for women between aged 27-45
- Medpage Today article re FDA rejection of Merck application for extension of Gardasil™ to older women