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.


  1. Could you please tell me…

    1. Is Dr Sin Hang Lee, MD quoted above, the same Sin Hang Lee, MD reported in “Natural News” as having teamed up with SANE Vax for “reliable HPV genotyping”?

    2. Can you point me to any peer-reviewed studies confirming Dr Sin Hang Lee’s testing methodology referenced in the above article? I’m puzzled that you claim his testing is “proprietary” and yet claim peer-review”. Which is it?

    3. Can you please publish Dr Sin Hang Lee’s results regarding the HPV vaccine?

    • Certainly! In answer to your questions:
      Question #1. Yes
      Question #2. You may find the methodology in the following peer-reviewed articles:

      1.      Lee, S. H., Vigliotti, V.S., Vigliotti, J.S. and Pappu, S. Routine human papillomavirus genotyping by DNA sequencing in community hospital laboratories.Infect Agent Cancer 2007; 2:11.
      2.      Lee S.H., Vigliotti V.S., Pappu S. Human papillomavirus (HPV) infection among women in a representative rural and suburban population of the United States. Inter J Gyn Ob.  2009; 105:210-214.
      3.      Lee, S.H., Vigliotti, V.S., and Pappu, S. Molecular tests for human papillomavirus (HPV), Chlamydia trachomatis and Neisseria gonorrhoeae in liquid-based cytology specimen.  BMC Women’s Health 2009; 9:8.     
      4.      Lee, S. H., Vigliotti, V.S., Vigliotti, J.S. and Pappu, S. Validation of human papillomavirus genotyping by signature DNA sequence analysis. BMC Clin Pathol  2009; 9:3.
      5.      Lee, S.H., Vigliotti, V.S., and Pappu, S. Signature sequence validation of human papillomavirus type 16 (HPV-16) in clinical specimens. J Clin Path.2010;63:235-239.
      6.      Lee, S.H. Guidelines for the use of molecular tests for the detection and genotyping of human papilloma virus from clinical specimens. In seriesMethods in Molecular Biology, volume Diagnosis of Sexually Transmitted Diseases. C. MacKenzie and B. Henrich, Vol. Eds. Series Ed. J. Walker. Humana Press. In Press 2011.

      Question #3 – The results are already included as an attachment in the SANE Vax press release.

  2. what a terrible thing
    all those young people – now damaged


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