This is an important new study of aluminum hydroxide (AlOH) adjuvant and Gardasil vaccine compared to saline placebo. This study is the result of a collaboration between the Shaw research group at the University of British Columbia and the Shoenfeld research group at Tel Aviv University. Dr Yehuda Shoenfeld is an internationally known expert on autoimmune diseases and editor of high-impact journals on autoimmune diseases. He has investigated ASIA syndrome (autoimmune syndrome induced by adjuvants) for many years. Dr Shaw’s group played a relatively minor role in this study. Most of the work was done by the Shoenfeld group.
This paper was accepted by the vaccine industry-friendly journal Vaccine, and then “temporarily removed” 4 weeks later. The Vaccine journal is probably the most important journal in the vaccine field. The vaccine industry definitely noticed this paper. The Vaccine journal is very pro-vaccine, and is well-funded by the industry. Its sometimes described as “prestigious”, but this is not a reasonable description. The Vaccine journal is merely well-funded. Vaccine has published sloppy, low-quality papers defending vaccine safety. Perhaps its “prestigious” to have a vaccine-critical paper accepted by the Vaccine journal. Vaccine has a low bar for papers praising vaccines, and a high bar for papers critical of vaccines.
Reasons for the removal have not yet been released (as of Feb 20, 2016). The publisher (Elsevier) has stated:
“The article in question has been temporarily removed as requested by Vaccine’s Editor-in-Chief Gregory Poland. In addition, Dr Poland has recommended the article be further reviewed. We will let you know when we have more information.“
Dr Gregory Poland is a vaccine scientist at the Mayo Clinic. His bio is here: http://www.mayo.edu/research/faculty/poland-gregory-a-m-d/bio-00078220
Dr Poland is vehemently pro-vaccine. In this editorial, he calls for the “funeral of antivaccination campaigns“: http://www.nejm.org/doi/full/10.1056/NEJMp1010594
Dr Poland is vehemently pro-vaccine. In this editorial, he calls for the “funeral of antivaccination campaigns“: http://www.nejm.org/doi/full/10.1056/NEJMp1010594
Dr Poland has in the past worked for Merck (the manufacturer of Gardasil). Dr Poland is reported to have worked on the “safety review committee” for Gardasil. However, we have been unable to find details about this relationship.
This new paper is important because it shows serious safety problems with both Al adjuvant and Gardasil. It reported harm (abnormal behavior and memory/learning impairment) at the lowest dosages of Al adjuvant tested so far. Gardasil caused autoimmune activity against the brain (specifically, it caused the production of antibodies reactive to brain proteins).
Each human dose of Gardasil contains 225mcg Al from the adjuvant. This corresponds to a dosage of 225mcg/40 kg =5.6mcg/kg per dose for a typical (40kg) tween girl. The mice in this study received the same dosage: 5.6mcg/kg in 3 doses (17mcg/kg total). The mice were 6-weeks old and the doses were spaced one day apart, in all groups. The mice were type C57BL/6, a widely-used research mouse with no particular susceptibility to brain diseases or autoimmune diseases.
The Al adjuvant dosage used in this study is far smaller than the amount of aluminum adjuvant injected into infants per the recommended CDC vaccine schedule:
Birth (Hep B): 74 mcg/kg (250 mcg for 3.4 kg infant)
2 month: 245 mcg/kg (1225 mcg for 5 kg infant)
4 month: 150 mcg/kg (975 mcg for 6.5 kg infant)
6 month: 153 mcg/kg (1225 mcg for 8 kg infant)
In this experiment, there were four groups, with 19 mice in each group.
- Control group: Received 3 injections of harmless saline.
- Al adjuvant group: Received 3 x 5.6mcg/kg Al in the form of AlOH adjuvant. As noted, this is the same dosage of AlOH adjuvant received by a 40kg teenage girl receiving all 3 doses of Gardasil. AlOH is generally considered the strongest immune activator of the Al adjuvants (other forms are Al phosphate and Al sulphate), and seems to have the greatest potential for neuro- and immune- toxicity.
- Gardasil Group: Received 3 doses of Gardasil vaccine in the same dosage received by a 40kg teenage female. The Gardasil also provided 3 x 5.6mcg/kg Al in the form of AlOH adjuvant.
- Gardasil + pertussis toxin group: Received 3 doses of Gardasil with pertussis toxin (Pt) added. Pt was added because it is known to increase permeability of the blood-brain barrier, and the researchers hypothesized that increased permeability of the BBB may increase damage to the brain. The results generally did not support this hypothesis. Results with Pt added were not significantly different than gardasil vaccine alone.
RESULTS
After receiving the injections, the mice were subjected to a variety of behavioral tests (at 3 and 6 months) and laboratory analysis. 5 mice from each group were sacrificed before the 6 month tests, so only 14 mice per group were used for behavioral testing at the 6 month date.
Selected results are explained below.
Forced swimming test (FST). The FST is the most widely used model of depression in rodents. It is commonly used for evaluation of antidepressant drugs, and experiments aimed at inducing and examining depressive-like states in basic and pre-clinical research. However, the FST may also indicate movement or joint disorders or pain. The FST is simple: mice are placed in a water bath for 6 minutes, and the duration of immobile/motionless floating (not swimming, jumping or attempting to escape) is measured.
The FST was performed twice: at 3 months and 6 months after vaccination. Results are below. Both Al adjuvant and Gardasil produced highly significant increases in immobility. Notice that immobility increased further (compared to control) at 6 months.
Y maze test. The Y maze test was used to assess spatial short-term memory and interest in novel environments. In this test, mice are initially confined in one of three arms of a maze. Later trials measure the time that mice spend in the other 2 arms they are not familiar with. A normal cognitively non-impaired mouse will recognize the old arm as familiar and spend more time in the new arms of the maze. A variant of the Y maze test is described here: http://sbfnl.stanford.edu/cs/bm/lm/bml_ymaze.html
In the Y maze test, Al adjuvant injection caused significant avoidance of the new maze arms at 3 months. Gardasil produced a non-significant effect. These effects could be the result of memory impairment (observed in other experiments), increased anxiety or other cognitive impairment.
Brain Autoimmunity. One month after the injections, blood serum was obtained and tested for antibody reactivity to a variety of substances. As expected, gardasil-injected mice had antibodies active against the human papilloma virus (HPV). Presence of these antibodies is indicative of immunity to HPV.
Blood serum antibodies were also tested for reactivity against alum (aluminum hydroxide), dsDNA (double-stranded DNA), B2GP1 (B-2glycoprotein-1), mouse brain proteins, and mouse brain phospholipids.
Reactivity to dsDNA or B2GP1 is indicative of autoimmune diseases such as lupus. These tests were performed because there have been claims that Gardasil and Al adjuvant have caused lupus-like disease in humans. You can read about these substances and their relationship to autoimmunity here:
Antibody reactivity to Al hydroxide, dsDNA and B2GPI was not observed.
However, the Gardasil-exposed mice had antibodies reactive to mouse brain proteins and mouse brain phospholipids (fats that comprise cell membranes). This is strongly indicative of autoimmune disease. The Gardasil vaccine caused the mice to produce antibodies attacking the brain. Antibodies attacking phospholipids are often present in lupus and other autoimmune diseases.
Note that “OD 405nm” means “optical density at 405 nanometers”. This is an optical measurement of antibody concentration. High optical density indicates high antibody concentration.
The results presented here indicate that Al adjuvant and Gardasil can cause brain damage at dosages that humans receive from Gardasil. The antibody tests indicate that Gardasil can cause the immune system to attack the brain.
Paper Conclusions
The paper concludes with these statements:
“In summary, both Al and Gardasil vaccine injections resulted in behavioral and cognitive abnormalities in mice.”
AND
“…it is likely that mice immunized with the HPV vaccine developed cross-reactive anti-HPV antibodies which in addition to binding to the HPV protein, may also bind to brain auto-antigens.”
AND
“In light of these findings, this study highlights the necessity of proceeding with caution with respect to further mass-immunization practices with a vaccine of yet unproven long-term clinical benefit [20,52] which is capable of inducing immune-mediated cross-reactions with neural antigens of the human host.”
Conflict to Come?
The acceptance and then removal of this paper sets up a potentially very important conflict between researchers that are leaders in their fields.
Dr Shoenfeld is a leader in the field of autoimmunity research and he is the editor of high-impact journals on autoimmune diseases. Dr Shaw has published many papers on aluminum neurotoxicity and is the first to seriously investigate Al adjuvant neurotoxicity. Dr Poland is a leader in the dubious field of vaccine research and promotion, and as editor of Vaccine, has a very influential position. The outcome of this conflict will likely have important consequences for the future of the vaccine controversy.
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