A consumer watchdog group that specifically focuses on vaccine safety, SANE Vax, Inc., sent a certified letter to U.S. Food & Drug Administration (FDA) Commissioner Dr. Margaret Hamburg on Sept. 6, asking the agency to review the possibility of contamination involving the vaccine Gardasil. Gardasil, manufactured by Merck & Co., is promoted as a preventive against the Human Papillomavirus (HPV), which is linked to the development of cervical cancer. SANE Vax reports independent testing indicates samples of the Gardasil vaccine may be contaminated with recombinant HPV DNA.
In its official news release, SANE Vax reports that 100 percent of the 13 samples of Gardasil they had tested were contaminated with recombinant HPV DNA. They report the vials of the vaccine were pulled from different lots being marketed in the United States, Australia, New Zealand, Spain, France and Poland. The tests were conducted on Merck’s HPV 4 Quadrivalent vaccine, Gardasil. The HPV DNA testing was performed by Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology lab.
The reason for the tests, which SANE Vax said it instigated at the request of medical consumers, was because consumers “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 the release.
In her letter to FDA Commissioner Hamburg, Norma Erickson, president of SANE Vax, writes, “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.”
SANE Vax is requesting that the FDA investigate the possible extent of any HPV DNA contamination of Gardasil HPV vaccine currently on the market to ensure public safety.