September 2, 2011
The Honorable Margaret A. Hamburg, M.D., Commissioner August 29, 2011
U. S. Food and Drug Administration (FDA)
10903 New Hampshire Ave.
Silver Spring MD 20993-0002
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 number of samples of HPV 4 Gardasil™ (Merck) for possible contamination by human papillomavirus (HPV) DNA in the vaccine lots distributed to physicians.
The laboratory has informed SANE Vax Inc. that one hundred percent of thirteen (13) samples of Gardasil™ taken from lots #1437Z, #1511Z, # 0553AA, #NL35360, #NP23400, #NN33070, #NL01490, #NM25110, #NL39620, #NK16180, #NK00140, #NM08120 and #NL13560, currently being marketed in the U.S.A., Australia, New Zealand, Spain, France, and Poland have been found to be positive for HPV DNA.
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. Its unique sequence is copied below for your reference.
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.
The SANE Vax Inc. data, including the electropherograms of short target sequencing used to validate the HPV DNA detected in the thirteen (13) Gardasil samples, each with a different lot number, are available for your review, provided appropriate safeguards are in place to protect the proprietary processes and information utilized by our laboratory to test the samples.
Thank you for your immediate attention to this matter.
Norma Erickson, President SANE Vax Inc.
154 Cecil Drive
Troy MT 59935
Signed on behalf of the Board of Directors, SANE Vax, Inc.
Leslie Carol Botha, Vice President of Public Relations
Janny Stokvis, Vice President of Research
Rosemary Mathis, Vice President, Victim Support
Freda Birrell, Secretary
Linda Thompson, Treasurer