Recombinant HPV DNA found in multiple samples of Gardasil

Anonymous
http://sanevax.org/sane-vax-to-fda-recombinant-hpv-dna-found-in-multiple-samples-of-gardasil/


"At the request of medical consumers concerned about HPV vaccine safety and efficacy, SANE Vax Inc. has retained a private laboratory to test a number of samples of HPV 4 Gardasil™ (Merck) for possible contamination by human papillomavirus (HPV) DNA in the vaccine lots distributed to physicians.

The laboratory has informed SANE Vax Inc. that one hundred percent of thirteen (13) samples of Gardasil™ taken from lots #1437Z, #1511Z, # 0553AA, #NL35360, #NP23400, #NN33070, #NL01490, #NM25110, #NL39620, #NK16180, #NK00140, #NM08120 and #NL13560, currently being marketed in the U.S.A., Australia, New Zealand, Spain, France, and Poland have been found to be positive for HPV DNA.

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. Its unique sequence is copied below for your reference.

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.

The SANE Vax Inc. data, including the electropherograms of short target sequencing used to validate the HPV DNA detected in the thirteen (13) Gardasil samples, each with a different lot number, are available for your review, provided appropriate safeguards are in place to protect the proprietary processes and information utilized by our laboratory to test the samples."

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Very interesting new development with Gardasil. I wonder if the media will pick up on this one or stay hushed so as not to upset the masses.
Anonymous
Could you please spell out the implications?
Anonymous
It could be nothing or something. On one hand, Gardasil is not supposed to have any whole virus. If they found that, it would be bad.

However, that is not what they said. What they said was a little vague. 100% tested positive for some DNA fragment. They did not say what fragments. They only specified one, a DNA fragment that is used to produce the capsid protein (which is the outer shell of the virus). The point is that this outer protein is what your body identifies and attacks. So if you produce the outside without generating an actual virus, your body can train on a safe target.

If this is really the only thing they found, then I don't see what the fuss was about. There is no potential for a DNA fragment to create actual virus. I think they want the public to believe that there is whole virus in the product, because it fits their agenda.
Anonymous
Anonymous wrote:It could be nothing or something. On one hand, Gardasil is not supposed to have any whole virus. If they found that, it would be bad.

However, that is not what they said. What they said was a little vague. 100% tested positive for some DNA fragment. They did not say what fragments. They only specified one, a DNA fragment that is used to produce the capsid protein (which is the outer shell of the virus). The point is that this outer protein is what your body identifies and attacks. So if you produce the outside without generating an actual virus, your body can train on a safe target.

If this is really the only thing they found, then I don't see what the fuss was about. There is no potential for a DNA fragment to create actual virus. I think they want the public to believe that there is whole virus in the product, because it fits their agenda.


Can someone educate us about their agenda or lack thereof? I briefly browsed the site and hadn't heard of issues with this vaccine before and I'm wondering whether these are legitimate concerns or another soon-to-be-discredited scare like the autism/MMR issue (Disclaimer: I was totally open to that hypothesis when it was first published but understand that it was at best sloppy science, if not much worse).
Anonymous
Anonymous wrote:
Anonymous wrote:It could be nothing or something. On one hand, Gardasil is not supposed to have any whole virus. If they found that, it would be bad.

However, that is not what they said. What they said was a little vague. 100% tested positive for some DNA fragment. They did not say what fragments. They only specified one, a DNA fragment that is used to produce the capsid protein (which is the outer shell of the virus). The point is that this outer protein is what your body identifies and attacks. So if you produce the outside without generating an actual virus, your body can train on a safe target.

If this is really the only thing they found, then I don't see what the fuss was about. There is no potential for a DNA fragment to create actual virus. I think they want the public to believe that there is whole virus in the product, because it fits their agenda.


Can someone educate us about their agenda or lack thereof? I briefly browsed the site and hadn't heard of issues with this vaccine before and I'm wondering whether these are legitimate concerns or another soon-to-be-discredited scare like the autism/MMR issue (Disclaimer: I was totally open to that hypothesis when it was first published but understand that it was at best sloppy science, if not much worse).


Just look at their web site. It's a vaccine victims site. http://sanevax.org/who-we-are/

Anonymous
Gardasil is a recombinant vaccine. Sanevax is trying to skew the science.

From:
http://www-scf.usc.edu/~uscience/gardasil_vaccine.html

"Gardasil is a type of recombinant vaccine, as shown in Figure 2. The Gardasil recombinant vaccines are made by taking genes that encode for capsid proteins of HPV types 6, 11, 16, and 18 and inserting them into yeast expression vectors, which are circular DNA pieces containing specific sequences that allow translation of those genes into proteins. The HPV protein-encoding genes are expressed in the yeast vectors to create large amounts of protein, which are then purified and used in the vaccine (McCormack and Joura; U.S. Food and Drug Administration, "Gardasil")."
Anonymous
In other words, there's supposed to be recombinant HPV DNA in it, right?
Anonymous
Right.
Anonymous
Anonymous wrote:Right.


NOPE!!!!


http://us2.campaign-archive1.com/?u=b62698a50aececa2aded9f56b&id=5a494bb655&eo=f19e67d489

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.

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.

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.’.

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.

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.” "
Anonymous
Anonymous wrote:
Anonymous wrote:Right.


NOPE!!!!


http://us2.campaign-archive1.com/?u=b62698a50aececa2aded9f56b&id=5a494bb655&eo=f19e67d489

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.

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.

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.’.

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.

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.” "


This is total nonsense.

SANE VAX takes issue with the design of Gardasil, fine. But it is fraud to make it sound like it is "contaminated". Gardasil contains a part of the viral DNA sequence in order to produce the protein necessary to trigger the immune reaction.

If you need to deceive in order to make your point, then you have lost the argument.
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