US: 13 of 13 Gardasil samples discovered to be contaminated with recombinant HPV DNA Print E-mail

 In addition to reading the below Press Releases, to learn more listen to the Special Report of September 5 2011 "Gardasil - A Vaccine Gone Bad" HERE

Tuesday September 6 2011

SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil™ To FDA: Requests Public Safety Investigation

By Norma Erickson, President

Troy, Mont.–(BUSINESS WIRE)– SANE Vax Inc. announced today they sent a certified letter to FDA Commissioner, Dr. Margaret Hamburg to inform the agency 100% of 13 samples of Merck & Companies HPV 4 Quadrivalent vaccine, Gardasil™ have been found to be contaminated with recombinant HPV DNA.  The vaccine vials were from different lots currently marketed in the United States, Australia, New Zealand, Spain, France and Poland.

Medical consumers from these countries asked SANE Vax Inc. to help determine if there is residual recombinant HPV DNA in the Gardasil™ vaccine currently used by their doctors. They are concerned that the recombinant DNA, if present, may have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil™ vaccinations.

According to Norma Erickson, president of SANE Vax,  “A sexually naïve girl developed acute juvenile rheumatoid arthritis at age 13 within 24 hours after the third Gardasil™ injection and her blood sample – tested two years later – was found to be positive for HPV DNA by a local clinical laboratory.”  A possible connection between HPV DNA in Gardasil™ and leukemia or lymphoma has also been raised by vaccine safety advocates, said Erickson.

The letter sent to Dr. Margaret Hamburg at the FDA stated, “One of the HPV DNA fragments detected in the vaccine is part of a synthetic construct (GenBank Locus SCU55993) for HPV11 major capsid protein L1 gene, a recombinant DNA genetically engineered specifically for manufacturing of the Gardasil vaccine.”

“There is no doubt that the HPV DNA found in the vaccine represents an adventitious agent left over from the DNA recombinant manufacturing process with potential adverse impacts on health safety of those vaccinated.  The recombinant DNA found in Gardasil is very tightly bound to aluminum hydroxyphosphate. When injected intramuscularly, this combination may function as a DNA vaccine with uncertain consequences,” said Erickson.

Both the FDA and the vaccine manufacturer assumed that there was no HPV DNA in Gardasil™ when the vaccine was approved for marketing, according to SANE Vax.

 “Because one hundred percent of the samples tested were positive for HPV DNA contamination, SANE Vax Inc. requests the FDA investigate the extent of the HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market and take appropriate actions to ensure public safety regarding future shipments,” stated the letter.

The HPV DNA testing was performed by Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology laboratory known in using cutting-edge DNA sequencing for molecular diagnoses.  This methodology was first reported to the FDA in 2006 and has been published in various peer-reviewed scientific journals, stated Erickson.
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September 6, 2011

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.

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.

[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.

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Monday September 5, 2011

SANE Vax Inc. Discovers Potential Bio-hazard Contaminant in Merck’s Gardasil™ HPV 4 Vaccine

By Leslie Carol Botha, Vice President of Public Relations

Gardasil victim found to have HPV DNA in her blood 2 Years Post-Vaccination
13 different vaccine vials – 13 different lots of Gardasil from around the world tested
Results – 100% contamination with HPV Recombinant DNA.

SANE Vax Inc. contracted with an independent lab to test for contamination and found HPV recombinant DNA (rDNA) in 13 vaccine vials. The Gardasil vials with different lot numbers were from New Zealand, Australia, Spain, Poland, France and three states in the U.S. 100% of the samples tested positive for the presence of the genetically modified HPV DNA.

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

In a certified letter mailed to FDA Commissioner, Dr. Margaret Hamburg on August 29, 2011, SANE Vax Inc. requested ‘the FDA investigate the extent of the HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market and take appropriate actions to ensure public safety regarding future shipments.’ 1.

Why Did SANE Vax Inc. Investigate Possible Gardasil Contamination?

The mother of a sexually naïve adolescent girl who developed acute onset Juvenile Rheumatoid Arthritis within 24 hours of her last injection of the Gardasil™ series contacted SANE Vax Inc. looking for more information.

In an effort to help her now very sick daughter the mother went to an MD practicing naturopath who conducted a toxicity test that eventually found HPV DNA in the girl’s blood. The significance of this finding is that it is highly unusual to find HPV DNA in the blood. HPV, if present in the body, exists in the epithelial (skin and mucosa) membranes. HPV or its DNA, by itself does not survive for any great length of time in the bloodstream. Why was the HPV DNA in her bloodstream two years post-vaccination?

Natural vs. Recombinant DNA
According to Dr. Lee, “‘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.”

What is a Recombinant DNA Virus?
Recombinant DNA (rDNA) refers to novel DNA molecules engineered by joining natural or synthetic DNA segments to other DNA molecules so that they can replicate in a living cell. The possibility for these replicable forms of DNA as uncertain toxic substance or as environmental hazard has been a concern since rDNA technology was invented in 1973. Thus, rDNA is considered a potential biohazard, and NIH has mandated that research institutions monitor and regulate its use.2.

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. However, Gardasil™ is the first vaccine found to be contaminated by a genetically engineered DNA used to manufacture virus-like particle proteins for the vaccine.

SANE Vax Inc. 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. SANE Vax Inc. believes the FDA should require every lot of Gardasil™ be tested for residual HPV DNA prior to shipment.

Gardasil Patient Product Insert Stated No Viral DNA’s in the Vaccine. In fact, Merck’s Gardasil™ Patient Product Inserts stated that there is ‘no viral DNA’ in the Gardasil vaccine. That is until April 2011 – when the line was glaringly absent from U.S. product inserts. 3.


The European Medicines Agency on line literature still states: ‘Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLP’s) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. The VLP’s contain no viral DNA; they cannot infect cells, reproduce or cause the disease.’ 4.

SANE Vax Inc.’s research found that 100% of the 13 samples tested were contaminated with viral HPV DNA residue, including a synthetic construct for HPV11 major capsid protein L1 gene, a recombinant DNA genetically engineered specifically for manufacturing of the Gardasil vaccine. All DNA residue discovered was firmly attached to the insoluble aluminum adjuvant in the vaccine, requiring a new protocol for detection.5

Dr. Lee firmly stated: “Based on medical literature and some of the FDA/Merck’s own publications, adventitious (coming from an outside source) DNA in an injectable protein-based vaccine may increase the risk of autoimmune disorders and gene mutation which may lead to malignancies.”

Merck, the FDA, CDC and the NCI Owe Medical Consumers Answers
SANE Vax Inc. wants to know how many adolescents who have suffered adverse reactions post Gardasil vaccination have HPV DNA in their blood. What are the medical ramifications should HPV DNA remain in the bloodstream for an extended period of time?

Does the aluminum adjuvant become the carrier for HPV DNA causing said DNA to remain in the blood and/or organs for an extended length of time?

Since viral DNA cannot replicate by itself (it needs a host cell) what happens if genetically engineered viral DNA enters a human host cell?

How will this now ‘genetically-engineered cell’ replicate? Will it mutate the host cell leading towards cancer?

How will genetically engineered cells affect the reproductive health of future generations?

How does the immune system react to the detection of a combination viral DNA and human DNA in what was once a ‘normal’ cell? Will the immune system fight the now genetically engineered human cell?

Medical consumers need to have these questions answered by Merck, the FDA, CDC, and NCI.

SANE Vax Inc.’s Position
SANE Vax Inc. believes the FDA and Merck should be transparent and tell medical consumers the potential health impacts the contaminant HPV DNA has brought upon the vaccinated children of the world. High rates of autoimmune disorders, 380 reports of abnormal pap tests, 137 reports of cervical dysplasia, and 41 reports of cervical cancer including Carcinoma in situ or Cervix carcinoma or Cervix carcinoma stage 0 or Cervix carcinoma stage I or Cervix carcinoma stage III 6 warrants an immediate investigation into Gardasil’s™ safety and efficacy.

SANE Vax Inc. believes the FDA and Merck should have tested, evaluated and quantified the risk of the residual recombinant HPV DNA in Gardasil™ before vaccine approval.

SANE Vax Inc. believes that both the FDA and Merck were at least negligent and perhaps fraudulent when claiming there was ‘no HPV (viral) DNA’ in the Gardasil™ vaccine.

Sources:


1. SANE Vax Inc. Letter to FDA Requesting Investigation into Gardasil Contamination

2. Policy on the use of Bio-hazardous Agents and Recombinant DNA in Research and Teaching Laboratories at the University of North Carolina at Greensboro

3. Gardasil™ Patient Product Insert

4. EMEA Scientific Discussion on Gardasil

5. Gardasil Contaminants by Country

6. VAERS Data