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.