Dear Dr. Hamburg:

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.

Thank you for your immediate attention to this matter.

Read the response from the FDA here.

SANE Vax Inc. issued the following rebuttal to the FDA response:

Dear Mr. Gardner:

Thank you for taking time to respond to our September 2, 2011 letter addressed to Commissioner Hamburg, informing the FDA of our discovery of recombinant HPV DNA in Merck & Co.’s HPV 4 vaccine, Gardasil currently marketed worldwide.

Your response dated September 22, 2011 seems to indicate that the FDA is unaware of, or indifferent to the harms HPV vaccines have brought to medical consumers;  primarily adolescent girls, as documented in the VAERS reports. Do you know how many parents have lost their perfectly healthy young daughters and how many parents still have to deal with the hardship of caring for their physically disabled or mentally impaired daughters as a result of Gardasil vaccinations?

There are at least seven reports published in the peer-reviewed medical journals containing documented links between HPV vaccination and a class of newly recognized, probably immune-mediated inflammatory neurodegenerative disorders, also described under the name of acute disseminated encephalomyelitis (ADEM).^[1-7] These inflammatory pathologies in the central nervous system may constitute a highly likely cause for the commonly reported seizures, physical and mental impairments or even deaths following Gardasil vaccinations.

Your response appears to show the FDA has definitively dismissed the aforementioned peer-reviewed articles and the possible link of the confirmed cases of ADEM to HPV vaccinations, a link that has been universally suggested by the authors of the science-based articles.

Contrary to your assertion, recombinant HPV DNA does not have to be able to infect cells, or to self-reproduce to cause or to trigger a disease. When adsorbed to cationic particles, ^{[8, 9]} including aluminum adjuvant, ^[10] the DNA molecules can be inserted into human cells via mechanisms only recently recognized as nonviral gene delivery to their targets.^[11]

Chromosomal integration of foreign DNA may occur through poorly understood mechanisms ^{[12, 13]} with uncertain consequences.^[14] Recombinant DNA molecules have long been recognized as potential biohazards.^[15] Retention of residual recombinant DNA in protein-based vaccines has been a concern in the virology industry since the induction of cancer as a single-cell phenomenon.  It is well documented that a single functional unit of foreign DNA integrated into the host cell genome might serve to induce cell transformation as a single event or part of a series of multifactorial events. ^[16]

SANE Vax Inc. believes it is the FDA’s responsibility to conduct an investigation based on the new scientific information to protect public safety. We believe it is irresponsible of the FDA to simply declare ‘…the presence of residual DNA is not a safety factor’ without ‘due diligence’ and supportive data.

Unlike other vaccines against contagious childhood infectious diseases, and even if proven effective as claimed, HPV vaccination is targeting 9-12 year old children to prevent 70% of cervical cancers which may develop at an average age of 54 at the death rate of <3 to 6.7 per 100,000 women in various population groups in the United States^[17]. Cervical cancer deaths are primarily the result of a lack of adequate gynecologic care.

For a vaccine to prevent a disease that may occur 40 years later, at a death rate of 3-6.7/100,000 – which may be further decreased by adequate and affordable gynecologic care, the risk to the vaccinated children should be zero to reap any benefits from said vaccination. As you are aware, all other childhood vaccines are used for public safety in the prevention of infectious diseases, not for a disease that may occur 40 years down the road in a finite demographic who have limited access to adequate gynecological care.

The members of SANE Vax and the thousands of parents whose daughters have suffered injuries or died after receiving Gardasil injections were shocked to learn for the first time that “Gardasil does contain recombinant HPV L1-specific DNA fragments,” as stated in your response on behalf of the FDA to our report of September 2, 2011.

Your statements, “The presence of these expected DNA fragments, which are inevitable in vaccine production; this DNA is not a contaminant; after purification of the vaccine, small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine; and Information concerning the presence of HPV DNA has never been in the U.S. labeling for Gardasil” seemed to play a semantics game when compared to the information data released to the consumers in public by the vaccine manufacturer with collaboration of the FDA and equivalent regulatory agencies in other countries.

Following are samples of some of the documents with relevant statements still available in the public domain:

1)      A briefing document submitted to the FDA for the Gardasil™ Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting held on May 18, 2006 attached to a letter signed by Patrick Brill-Edwards, MD, Director Worldwide Regulatory Affairs Vaccines/Biologics of Merck Research Laboratories dated April 19, 2006, made public and posted on the FDA website, clearly stated that the vaccine (sic) “…contains no viral DNA”.

2)      In another Gardasil® Supplemental Biologics Licensing Application for Use in Anal Cancer Prevention submitted as Briefing Document presented to the FDA VRBPAC on 17-Novemner-2010, it is again stated under 3.2 GARDASIL®- “The Quadrivalent HPV (Types 6, 11, 16, 18) Vaccine GARDASIL®is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”

3)      In Submission Control No. 102682 to Health Canada by Merck Frosst Canada Ltd. GARDASIL™ – Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18), Recombinant Vaccine, Date 2007/03/16, it is stated “Gardasil™ contains HPV 6, 11, 16, and 18 L1 proteins in addition to the following excipients: amorphous aluminium hydroxyphosphate sulphate adjuvant, sodium chloride, L-histidine, polysorbate 80 (PS-80), sodium borate, and water for injection (WFI). The product contains no preservative or antibiotics. Gardasil™ is not a live virus vaccine. It contains no viral DNA and is not capable of causing infection. All excipients found in the drug product are acceptable for use in drugs according to the Food and Drug Regulations.”

4)      In United Kingdom, Sanofi Pasteur MSD Limited Summary of Product Characteristics last updated on the eMC: 26/08/2011 states that Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. “The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.” http://www.medicines.org.uk/emc/document.aspx?documentid=19016

5)      In an Australian Public Assessment Report for Gardasil submitted by Merck Sharp & Dohme (Australia) Pty Ltd February 2011, it states that GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce. http://www.tga.gov.au/pdf/auspar/auspar-gardasil.pdf

6)      In New Zealand Ministry of Health Information for Health Professionals Data Sheet submitted by Merck Sharp & Dohme (NZ) Limited  on 29 April 2009, it states that GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce. …Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of borax, and water for injection.

7)      In the document issued April 2011 and titled as USPPI 9883616 Patient Information about GARDASIL®, the medical consumers are informed “The ingredients are proteins of HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.” There is no reference to DNA in the vaccine although yeast protein which is an adventitious substance is disclosed.

8)      In HIGHLIGHTS OF PRESCRIBING INFORMATION 9883616, April 2011. GARDASIL is described as a “sterile suspension for intramuscular administration. Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein/dose, and water for injection.” There is no reference to DNA in the vaccine although yeast protein which is an adventitious substance is disclosed and listed the amount present to be <7 mcg/dose.

The above documents clearly indicate that all documents #1- #6 issued prior to April 2011 contained the words ‘no viral DNA.’ However, the same reference has not been on the last two documents, #7 and #8 issued in April 2011. Comparing your statements with the history of records, it is highly disturbing to find out now that the FDA and vaccine manufacturer knew from the very beginning and withheld such an important material fact from consumers; namely that  Gardasil has always been contaminated by residual recombinant HPV DNA.

Your statement ‘this DNA is not a contaminant’ is a simply another semantics game designed to evade inconvenient information. It grossly contradicts what the manufacturer has acknowledged and presented to the public.

For your information, the US patent #6,602,697 granted to Merck states:

“Specifically, it has been found that most contaminating biomolecules, including DNA, lipids and proteins are removed from the lysate.”

“Quantitation of L1 was made using a 2.5 mg load and yeast contaminants were quantitated at 20.0 mg loading.”

Therefore, again the record shows that the vaccine manufacturer has considered both residual DNA and yeast protein to be contaminants in the final product and as such must be removed. If not completely removed, it must be disclosed when it was detected. For example, the contaminant yeast protein was detected and listed as <7mcg/dose in April 2011 (See document above #8). Why was the contaminant HPV DNA not disclosed if known to exist?

To help medical consumers understand these very disturbing statements in your response, please provide answers to the following questions:

1)      How large, in number of base pairs, are these recombinant HPV DNA fragments that are known to exist in the vaccine Gardasil?

2)      Are these DNA fragments in the vaccine still spliced into plasmids?  If not, please show data.

3)      Can you provide a copy of the document in which the vaccine manufacturer reported that Gardasil does contain these DNA fragments, along with the date of the report made to the FDA?

4)      What was the decision of the FDA issued on the above report? Why not make public the information about the existence of HPV DNA in the vaccine products? Who signed off the decision?

Your categorical denial that ‘there is no scientific evidence linking juvenile rheumatoid arthritis and vaccination with Gardasil’ grossly contradicts the safety data observed in the clinical trial which showed  rheumatoid arthritis, including juvenile rheumatoid arthritis, occurred 3 times more frequently in the Gardasil®-vaccinated subjects than in the placebo control subject receiving aluminum placebo.^[18] Complexes of anti-DNA antibodies with microbial or self DNA may play a role in the activation of B cells by Toll-like receptors and surface IgM rheumatoid factor.^{[19, 20]}  The immunotoxic reactions may be further augmented by the aluminum adjuvant in the vaccine.^[21]

Your response and this letter of rebuttal will be posted on the SANE Vax website so medical consumers will be properly informed of the contradicting evidence on the risks and benefits of Gardasil vaccination. This will preserve their right to make an informed choice regarding the use of Gardasil for their families.

SANE Vax Inc. and the injured patients along with their families urge the FDA to immediately appoint a committee composed of unbiased scientists to review the safety impact of the newly discovered residual recombinant HPV DNA in Gardasil. All cases of unexplained deaths of young women following Gardasil immunizations must be reviewed and the brains obtained at autopsies re-examined by qualified neuropathologists to determine if an immune-based acute disseminated encephalomyelitis might be the cause of death. Research must be conducted to determine if residual HPV DNA might have played a role in triggering the inflammatory lesions of the brain as a cause of death.

If you need more scientific evidence which will contradict your evaluation of the risks and benefits of Gardasil for adolescents age 9-26; especially those 9-12 years old, in the United States, please contact SANE Vax Inc. at your earliest convenience.

Thank you for your cooperation in performing your due diligence to reduce the unnecessary risks to future generations in this country.

Sincerely,

References

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4. Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2010 Oct 9. doi:10.1136/jnnp.2010.214924
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