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 […]
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SANE Vax Inc. Announces the Discovery of Viral HPV DNA Contaminant in Gardasil
By Norma Erickson, President Phone calls from mothers with children who have experienced adverse events after HPV vaccination is part of the everyday routine for members of the SANE Vax team. This one was different. A sexually naïve 13 year old girl from Toronto had developed acute juvenile rheumatoid arthritis within 24 hours after the […]
SANE Vax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil
The Honorable Margaret A. Hamburg, M.D., Commissioner U. S. Food and Drug Administration (FDA) 10903 New Hampshire Ave. Silver Spring MD 20993-0002August 29, 2011 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 […]
SANE Vax to CDC: Request for additional data on HPV vaccine post-marketing monitoring
Lauri Markowitz, M.D. Centers for Disease Control and Prevention MS E05, 1600 Clifton Road Atlanta, GA 30333 lem2@cdc.govAugust 31, 2011 Dear Dr. Markowitz: Thank you for your August 29, 2011 response to my letter requesting additional information about post licensure monitoring for Gardasil™ from the CDC. Before relaying your response to medical consumers, I would […]
SANE Vax to CDC: Request for post-HPV vaccination monitoring data
Lauri Markowitz, M.D. Centers for Disease Control and Prevention MS E05, 1600 Clifton Road Atlanta, GA 30333 lem2@cdc.gov July 26, 2011 Dear Dr. Markowitz: Thank you for your letter dated July 14, 2011 in response to the SaneVax Inc. letter of 28 May 2011, concerning the post-licensure monitoring project on Gardasil™, which was approved for marketing […]
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