Author Topic: Potential Bio-hazard Contaminant found in Merck’s Gardasil™ HPV 4 Vaccine  (Read 7602 times)

rosemary

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

By Leslie Carol Botha, Vice President of Public Relations

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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

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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?

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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.”


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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.

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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.”

Continued...

http://sanevax.org/sane-vax-inc-discovers-potential-bio-hazard-contaminant-in-merck%E2%80%99s-gardasil%E2%84%A2-hpv-4-vaccine/

Robyn

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See many products go on the market that contain things they shouldn't.  Only to be recalled later.   How would we all like some biohazard material, or unproven to be infectious retroviruses in our vaccines?  Oh I think that's already happened before.
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Karin

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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.”

Well, I just wanted to throw out there that in his second year, my son developped a mastocytoma on his thigh, right where they used to do the immunization injections as an infant. Now, the Hep B vaccine is using the same recombinant technology as Gardasil, also using yeast cells. The final injected product contains a hefty dose of aluminum, as well as 1 to 5% of residual yeast protein. Now I would not be suprised if it contained contaminant recombinant Hepatitis B virus as well, after reading the above.

So to the question 'What are the consequences of this contaminant recombinant virus bound to aluminum?', I propose the following answers:

Maybe a local formation of a mastocytoma. -> Check, my son had that.
Maybe chronically elevated liver enzymes, as a reaction to a potential Hep B contaminant that chronically infects the body? -> Check, my son has that.
Maybe an abnormal immune reaction against yeast protein. -> Check, my son still has very high IgG titers to Saccharomyces.
Maybe a development of inflamatory bowel disease due to this abnormal reaction to yeast aquired BEFORE his gut was colonized (since Hep B is given at birth). -> Check.

A lot of 'maybe's, but there is one thing I will always regret, is to have given that Hep B shot at birth to my son.
« Last Edit: September 08, 2011, 10:00:53 PM by Karin »

cassea

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A lot of 'maybe's, but there is one thing I will always regret, is to have given that Hep B shot at birth to my son.

I hear you Karin. My regret is in allowing my eldest daughter to have the gardisal shots. I have not allowed my younger 2 to have it.

We allowed these in ignorance though. I hold the company marketing the vaccine and the government responsible for the damage rather than myself. It shouldn't be the case that we need to do this research for ourselves - there are those who are responsible to make certain these things are safe, but they are not doing their job.

jace

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The Gardasil story is Pharma arrogance writ large.  The trials in India caused six deaths, and a huge percentage of adverse reactions.  I heard yesterday that immunisation is to be compulsory in California.  One mother was thinking of moving because of this.

We mums just want to do the best for our children, and we trust the advice our doctors give us, until we become aware that they are not acting in our best interests though they may well think they are.  I was fortunate to have a mother that had already worked out that mass multiple vaccination could be damaging, so I was able to avoid an aggressive vaccination schedule for my kids.  Ever grateful, Ma!   

As with most things, it's not what you do, it's the way that you do it.  The idea of Hep B at birth just seems obviously wrong to me.  The idea of giving several vaccinations in one go, sometimes overwhelming the infant's immune system, at four months, and on and on is for economy of scale, not health.

Vaccination is a powerful tool.  It is not being used wisely.  It may overall be doing more harm than good.   And the manufacturers are laughing all the way to the bank.
IinME  All it takes for evil to prevail is for good men to do nothing. MEactionUK

Daisymay

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Scary, but really good that this is coming out. I hope the media picks up on this...

Mark3981

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No doubt the media knows about this and is helping keep it quiet.

rosemary

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INITIATIVE CITOYENNE ( Belgium) has just published the translation of the SANE Vax Press Release into French

http://www.initiativecitoyenne.be/article-contamination-possible-du-gardasil-avec-de-l-adn-heterogene-potentiellement-cancerigene-83796755.html


Justin Reilly

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wow, merck seems pretty shady on this, quietly removing the statement that gardasil wasn't contaminated.
Silence = A Living Death

Robyn

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Yes but they are trying to do damage control with flooding the news tonight with how giving only 1 or 2 doses are better than giving 3 as far as effectiveness.  How convenient! Never mind the contaminant that women have already been injected with. I guess they think 1 shot less gives less risk.  Give me a break some of these girls were 11 years old, I think some even younger.  And then there is was the rotavirus vaccine that was recalled last year containing pig DNA and another vaccine with a retrovirus in it.  Oh yes these have been safe for years.  That's why they are now currently looking into the safety of vaccines.  A bit late.

http://www.webmd.com/sexual-conditions/hpv-genital-warts/news/20110909/under-3-doses-of-hpv-vaccine-may-be-effective?src=RSS_PUBLIC

It was on my local news tonight as well. 

Here's the info on Rotavirus:  http://www.achildgrows.com/2010/03/23/fda-warns-using-one-brand-of-rotavirus-vaccine/
« Last Edit: September 11, 2011, 04:49:07 AM by Robyn »
"If Freedom of Speech is taken away then dumb and silent we may be led, like sheep to the slaughter,"
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rosemary

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Re: Potential Bio-hazard Contaminant found in Merck’s Gardasil™ HPV 4 Vaccine
« Reply #10 on: September 11, 2011, 07:34:08 AM »
SANE Vax Inc  Announces the Discovery of  Viral HPV DNA Contaminant in Gardasil

http://philosophers-stone.co.uk/wordpress/2011/09/sane-vax-inc-announces-the-discovery-of-viral-hpv-dna-contaminant-in-gardasil/

By Norma Erickson, President

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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, 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:
 1.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.
 2.‘Wild DNA’ is any DNA found in nature.
 3.‘Viral DNA’ is any DNA isolated or derived from the genome of a virus.
 4.‘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.
 5.‘Recombinant DNA,’ also known as genetically modified DNA, is considered a biohazard.[ii] [iii]
 6.‘DNA residue’ is left-over DNA in a final product after the product has been purified to remove the DNA.
 7.Any DNA can be adsorbed (attached) to aluminum adjuvant.
 8.‘Mutagenesis’ is the formation or development of a genetic mutation. Gardasil has not been evaluated for mutagenesis.[iv]
 9.‘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.

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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][/quote]

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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?


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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