SANE Vax Inc. Announces the Discovery of Viral HPV DNA Contaminant in Gardasil

By Norma Erickson, President


Phone calls from mothers with children who have experienced adverse events after HPV vaccination is part of the everyday routine for members of the SANE Vax team. This one was different. A sexually naïve 13 year old girl from Toronto had developed acute juvenile rheumatoid arthritis within 24 hours after the third Gardasil™ injection. Two years later, her blood was tested by a local clinical laboratory and found to be positive for HPV DNA.

Local physicians could provide no explanation. Human papillomavirus is an epithelial virus which does not survive in the blood stream for long. HPV only thrives on skin and mucosal membranes. They could not explain why HPV was in her blood instead of HPV antibodies.

Desperate for answers, her mother called SANE Vax to see if there was any research available that might shed some light on her daughter’s situation. Not having any contradictory information available, the SANE Vax team agreed to contact some experts for their professional opinion.

Many phone calls and much research later, the only option left was to try to determine whether Gardasil could have been the possible source of HPV in the girl’s blood.

Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology laboratory well-known for using cutting-edge DNA sequencing for molecular diagnoses,[i] was initially contracted to examine a single sample of Gardasil for possible contamination. This sample tested positive for recombinant viral HPV-11 and viral HPV-18 residues, both of which were firmly attached to the aluminum adjuvant.

In order to understand the possible implications of such contamination, medical consumers must understand the following definitions:

There is no such thing as an independently ‘live virus’. Any and all viruses must be embedded in a host cell in order to reproduce.
‘Wild DNA’ is any DNA found in nature.
‘Viral DNA’ is any DNA isolated or derived from the genome of a virus.
‘Recombinant DNA’ is a DNA that has been artificially attached to DNA from another species or a man-made DNA construct, in other words, genetically modified.
‘Recombinant DNA,’ also known as genetically modified DNA, is considered a biohazard.[ii] [iii]
‘DNA residue’ is left-over DNA in a final product after the product has been purified to remove the DNA.
Any DNA can be adsorbed (attached) to aluminum adjuvant.
‘Mutagenesis’ is the formation or development of a genetic mutation. Gardasil has not been evaluated for mutagenesis.[iv]
‘Carcinogenesis’ is the initiation of cancer formation. Gardasil has not been evaluated for carcinogenesis.⁴
Concerned that recombinant DNA, if present, might have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil™ vaccinations, medical professionals and vaccine safety advocates from the United States, Australia, New Zealand, Spain, France, and Poland donated samples of Gardasil™ currently distributed in their countries to be examined.

In all, 13 different lot numbers were tested by Dr. Sin Hang Lee. One hundred percent of the samples were found to be contaminated with viral HPV DNA residues, firmly attached to the aluminum adjuvant.

At the time of Gardasil™ approval, both Merck and the FDA represented that there was no viral DNA in the vaccine.[v] [vi] [vii] Both the FDA and Merck knew, or should have known, that any residual recombinant HPV DNA left in the vaccine could pose a health risk to any medical consumer injected with Gardasil™.[viii] [ix]

Medical consumers need the answers to the following questions:

If recombinant HPV DNA attached to aluminum adjuvant enters a person’s blood, how long will it remain there?

What autoimmune-related disorders could result from this contamination?
Is it possible for this contamination to initiate gene mutations which may lead to cancer?
What genetic changes (mutagenesis) could occur should the residual HPV DNA enter and begin reproducing in a human cell?
SANE Vax believes the FDA should have required Merck to test for, evaluate and quantify the risks of residual recombinant HPV DNA in Gardasil™ before granting approval for marketing the vaccine. SaneVax believes the FDA should require every lot of Gardasil™ be tested for residual HPV DNA prior to shipment.

It is time for the manufacturer and the FDA to do their jobs. It is time to disclose the health impacts contaminant viral HPV DNA may have unleashed on unsuspecting medical consumers around the globe.

SANE Vax Inc. has sent a letter to Dr. Margaret Hamburg, FDA Commissioner to inform her of the contamination and request FDA investigation into the extent of HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market. It was also requested that the FDA take appropriate actions to ensure public safety regarding future shipments.

Anything less than immediate action is not acceptable.


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[i] DNA sequencing for molecular diagnoses

[ii] Potential Biohazards of Recombinant DNA

[iii] POLICY ON THE USE OF BIOHAZARDOUS AGENTS AND RECOMBINANT DNA IN

RESEARCH AND TEACHING LABORATORIES AT THE UNIVERSITY OF NORTH

CAROLINA AT GREENSBORO

[iv] Gardasil: Highlights of Prescribing Information

[v] Developing an HPV vaccine to prevent cervical cancer and genital warts

[vi] Gardasil (Human Papillomavirus Vaccine) Questions and Answers – Gardasil, June 8, 2006, FDA

[vii] VRBPAC Briefing Document, FDA, 17 Nov 2010,see section 3.2, page 12

[viii] History, precedent, and progress in the development of mammalian cell culture systems for preparing vaccines: safety considerations revisited.

[ix] In vivo study of hepatitis B vaccine effects on inflammation and metabolism gene expression.