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

Comments

  1. Who was the independant lab that tested the vaccines? Anti vaxers continually scream about transparancy regarding studies etc, yet you cannot be forth coming about details regarding information such as this?

    The hypocracy stinks to high hell.

    • Please read the second paragraph of the article above.

    • ducatidave says:

      Scott, know what? You win. So go ahead and inject yourself and your kids with all the vaxx you want. We’ll pass.

    • If only such vehemence was displayed regarding vaccine “safety,” why don’t you question Merck and the FDA with such tenacious fervor?

      • How about giving Scott the information that he asked for, rather than harassing him for not believing what ever you say regardless of how outlandish it sounds?

        Cheers.

        • Matt, why are you and Scott and others like you even on this site giving people grief. This is a site disputing the use of vaccines as safe. If you are any kind of intelligent, you can find your own answers to your own questions. We all did. This is a forum of people not the doctors/researchers doing the research, why don’t you pose your questions to people to whom have all the research to give you your answers. Why would you even trust people who are so diluted like the kool-aid drinkers on this site. I’m with DixieDiva. I have done enough research and found that I wouldn’t give my children vaccinations ever! I took my a year to come to that conclusion. For the sake of the people you love…. quite getting pissy and start getting busy, the answers if you chose to be honest with yourselves, will haunt you!

  2. I see a new thread has started about the same story. So I will have to ask here as well:

    1) What was the name of the laboratory that did the tests?

    2) Which vaccines are “necessary” and “effective” to match the “N” and “E” in SANE?

  3. DOES GARDASIL CAUSE CANCER?

    This is a undoubtedly a special question considering that Gardasil is promoted as a vaccine which is intended to ultimately prevent cancer. However, the question is both relevant and justifiable because a credible and satisfactory answer has not been presented.

    The presence of viral HPV recombinant DNA (rDNA) contamination which has been discovered in samples of the vaccine from New Zealand, Australia, Spain, Poland, France and three states in the U.S. is of deep concern.

    As Dr. Lee states: “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”.

    Further, quote from the above press release from Sane Vax:
    “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”.

    Information in the package insert states that the vaccine has not been tested for carcinogenicity. (Absence of evidence is not evidence of absence!)

    In addition, there is the extremely relevant issue of “replacement”, a normal phenomenon in virology where strains which have been removed are always replaced by new ones. It is not known to anyone, including the manufacturer, whether the new virus strains are more carcinogenic than the original ones which have been removed.

    In other words it cannot possibly be guaranteed that Gardasil does not increase the risk of cancer before at least the following three issues have been seriously considered:

    – the presence of recombinant DNA (rDNA)
    – lack of carcinogenicity testing of the vaccine
    – replacement

    It may be most inappropriate and have deeply tragic consequences if Gardasil, which is sometimes incorrectly termed a “cancer vaccine” is shown to actually increase the risk of cancer.

  4. Mothers Alliance Ireland has repeatedly expressed their concern about the safety and effectiveness of this vaccine. We have made our cncerns known to the Irish Health Service Executive and others in positions of power in our country, calling for a moritorium on vaccinations in this country until parents were fully informed about the issue and capable of making a fully informed decision for their children. However our pleas have been ignored or rejected in some cases. In view of this latest revelation, we are now calling on our Government for that moritorium to be put in place immediately.

  5. Scott Hansen , I’m thinking perhaps you need glasses and to read a few History books and do the proper research. Thank goodness we have people who actually are willing to check what is in these vaccines because it is blatantly obvious that the pharmaceutical companies actually aren’t priortising our children’s health.
    As a parent I vaccinated my children thinking I was doing the right thing, right from the beginning my children had adverse reactions. Initially I wanted to believe these reactions were a coincidence just like I was assured by Doctors, however, you really can’t have that many coincidences. So perhaps most of us so called anti vaccine people are people who have either dealt with patients (yes that includes some Doctors) or are parents who have had children who have suffered long term consequences from vaccination. Mr Hansen you obviously haven’t had a child in that position. So, thank you Sane Vax.

  6. Gulf War Illness / Syndrome

  7. I see you have posted several reports on the role of homeopathy in health.
    Homeopathically prepared dilutions are safe from contamination such as these.

    I think you may be very interested in these experiences of using homeopathy as a safe method of immunisation:

    http://www.ncbi.nlm.nih.gov/pubmed/20674839

    It is not ‘Classical Homeopathy’, but a new development by a Dr Isaac Golden from Australia.
    He has figures from years of research:

    http://www.homstudy.net/Research/

    His method has been successfully applied during a leptospirosis outbreak in Cuba, where 2.3 million people were immunised using this protocol, with a ridiculously low incidence of the disease in this group. And all the rest of the country can even be taken as a control group.

    The weird thing about all this? Neither the institute in Cuba who implemented this immunisation programme, not Dr Golden himself can get their figures published in any medical journal…

    Thank you for your work!

  8. With regards to SANE Vax Inc.’s position about possible adverse effects of the HPV vaccine –
    ‘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 ‘ Chapter 9 from the National Academies Inc’s Press book Adverse defects of vaccines: Evidence and causality is well worth read. The chapter reports on a review of literature for evidence of adverse reactions to the Human Papilloma virus vaccine.

    It found one causal relationship between HPV vaccine and an adverse reaction. It stated “Evidence favours acceptance of a causal relationship between HHPV vaccine and anaphylaxis.”

    For the other 12 adverse reactions no causal relationship was found because there was insufficient or absent evidence for reasons such as the persons concerned receiving more than one vaccine or no base line data about the incidence of the abnormal event in the comparable group not receiving the vaccine; or insufficient information provided in the paper reviewed.

    The other twelve illnesses investigated were Acute Disseminated Encephalomyelitis, Transverse Myelitis, Neuromyelitis Optica, Multiple Sclerosis, Guillain-Barré Syndrome, Chronic Inflammatory Disseminated, Polyneuropathy, Brachial Neuritis, Amyotrophic Lateral Sclerosis, Anaphylaxis, Transient Arthralgia, Pancreatitis, Thromboembolic Events, and Hypercoagulable States.

    You can download the ‘uncorrected proofs or read the uncorrected copy on line.
    Here is the link – http://www.nap.edu/catalog.php?record_id=13164#aboutprepub

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  14. Godofredo Arauzo says:

    INEFFECTIVE OF THE HPV VACCINE SEEN BY
    DOCTOR OF PERU DEPTH
    The scientific efficacy of this vaccine will be determined just the years 2025-2030 because research has begun the decade of 2000. From its inception until the appearance of carcinoma of the cervix (CCU), takes on average 25 to 30 years; definitely not the HPV causes the (CCU); in the onset of this disease involve multiple risk factors, among them are suspected to HPV. yes it is proven that sex generates this condition: Mix in 130.000 nuns found no CCU.
    To accept that a bacteria or virus causes a disease inevitably have to fulfill the Koch’s Postulates:.
    http://www.xatakaciencia.com/salud/los-postulados-de-koch
    1 – The agent must be present in every case of the disease and absent in the healthy.
    2 – The agent should not appear in other diseases.
    3 – The agent must be isolated in pure culture from lesions of the disease.
    4 – The agent has to cause the disease in an animal capable of being inoculated.
    5 – The agent must be isolated from new lesions in experimental animals.
    1. Principle: not found any physical HPV cervical carcinoma (CCU), has found only his DNA immunology, which can be interpreted as the virus is present or is a residual immunity. and immunological detection was not meet in all CCU;only 90% of CCU: does not fulfill this first principle;
    2. Principle: The agent also appears in the warts does not appear only in the CCU: not satisfy this principle;
    3. Principle: It have not been isolated cultivating from a growing CCU: Does not fulfill this principle
    4. Principle: The HPV inoculate a laboratory animal, produces the disease; as it have not been isolated from the CCU, it has not inoculated to laboratory animal; violates this principle and
    5. As it was not inoculated in laboratory animal because they was not found in a CCU, . also violated this principle.
    Consequently, HPV does not fulfill any principle of the Koch’s postulates; this postulates is accepted as dogma in the scientists physicia world to ensure that it is the causative agent of the CCU.
    Until March of this year, 95 girls had death; until 2009 had 20.000 adverse effects and more of one thausand disabled irreversible damage. The Vaccine Adverse Effects Reaction (VAERS) reports too that the vaccine produced abnormal Pap 376, anogenital warts 108, HPV infections 224, 41 cervical cancers, 21.634 adverse events and 95 death after vaccination. The VAERS say that is known only 1 to 10% of adverse effects and deaths from unlucky vaccine; therefore, have been 216.340 adverse effects and 950 death alone in the U.S. and all the damages listed add a zero.
    http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d
    Dra. Harper, who helped develop the vaccine by Merck, refers that the vaccine was not investigated in children under 15 years and the vaccine given to children under 11 years is a big public experiment.
    http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gardasil-hpv-marketing.html
    The vaccine was approved for girls to not contaminated with HPV; Dr.Howenstinc say that if women infected with HPV is vaccinated, have the opportunity to acquire a 44.6% CCU
    http://www.newswithviews.com/Howenstine/james170.htm.
    Sane vax has discovered that the vaccine is contaminated with the DNA HPV and has raised its concerns to the president of the FDA Margaret Hamburg
    http://www.mecfsforums.com/index.php?topic=9331.0
    To introduce the vaccine are using the marketing of fear:
    http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht
    http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht
    The HPVs lives in wild and domestic animals, we pollute us from first day of birth, is found in the doorknobs, in towels, in the nails, on fomites, in gloves and specula of gynecologists. It is doubtful that sex is the only means of contamination
    http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/investigadores-descubren-el-v
    The PVH live too in 400 nanometers more external of our skin; if he HPV live on our skin, our immune system produces cellular and humoral immunity or that our bodies are being vaccinated in a natural way; if the HPV live in our skin, by inference we can ensure that too they live too in the mucous membranes ..
    http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
    This vaccine is genetically modified, the vaccines known are original virus known and the vaccine is prepared to prevent infection only by the HPV 16 and 18
    The HPV is not distributed uniformly over the world. The HPV 18 has been found in Canada in only 3%, more common is HPV 31, in my country Peru there are no studies that established the predominant HPV types;
    This vaccine contains 225 mcg. Aluminum, a suspected cause Alzheimer’s and Polisorbatol 80 which is a powerful contraceptive; in experimental animals produces sterility; is carcinogenic and mutagenic, also contains sodium borate considered poison, not used in medicinal preparations.
    http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html
    http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
    For the dangerous reasons from Peru, depth, Huancayo, I believe that this vaccine is a Fraud?, Robbery?, Swindle? , Rough joke?; it is not scientifically proven at the moment, its effectiveness, will be determinated just the years of 2025-2030.

    Dr. Godfrey Arauzo
    E mail: godo.ara @ gmail.com
    Phone: 05164252052

Trackbacks

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