- 3 Girls Dead, Others Hospitalized After Gardasil HPV Vaccine
- SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil To FDA: Requests Public Safety Investigation (Pharma Live):
TROY, Mont.–(BUSINESS WIRE)–Sep 6, 2011 – 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.”
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