Health Canada has authorized the sale of Arepanrix™ H1N1 vaccinebased on no conclusive clinical testing. The authorization is based on the Health Canada review of available data on the quality, safety and immunogenicity of similar vaccines, which established the benefit/risk profile in favour of inoculating the Canadian population.
Read the Notice of Decision issued by Health Canada. The decision by the Health Minister was based on a belief (not qualified or informed) that immediate action is required to deal with the H1N1 risk. The assertion that the decision is based on limited clinical testing is being misapplied.There has been NO conclusive results from any clinical trials on the Arepanrix H1N1 vaccine.
This report is designed to inform you how the risks outweigh the benefits of the vaccine. It will demonstrate how the Health Canada assessment is flawed and contradictory to established research on the detrimental health effects of the vaccine ingredients contained in Arepanrix.
Description and Composition
Arepanrix™ H1N1 (AS03-adjuvanted H1N1 pandemic influenza vaccine) is a two-component vaccine consisting of an H1N1 antigen (as a suspension), and an AS03 adjuvant (as an oil-in-water emulsion).
The virus is inactivated followed by formaldehyde treatment and disrupted with sodium deoxycholate.
Preservative content:
5µg (micrograms) Thimerosal USP per 0.5mL dose or 2.5 micrograms organic mercury (Hg) per 0.5mL dose
Adjuvant:
The AS03 adjuvant system is composed of DL-α-tocopherol, squalene and polysorbate 80 in a 3mL vial:
DL-α-tocopherol: 11.86 milligrams/0.5mL dose
Squalene: 10.69 milligrams/0.5mL dose,
Polysorbate 80: 4.86 milligrams/0.5mL dose
Analysis of Ingredients
Formaldehyde
According to the Australian National Research Council, fewer than 20% but perhaps more than 10% of the general population may be susceptible to formaldehyde and may react acutely at any exposure level.
More hazardous than most chemicals in 5 out of 12 ranking systems, on at least 8 federal regulatory lists, it is ranked as one of the most hazardous compounds (worst 10%) to ecosystems and human health (Environmental Defense Fund).
Formalyn a 37 percent solution of gaseous formaldehyde which includes methano (used in vaccines as a tissue fixative) is considered a hazardous compound, and its vapor is toxic.
In the body, formaldehyde can cause proteins to irreversibly bind to DNA. Laboratory animals exposed to doses of inhaled formaldehyde over their lifetimes have developed more cancers of the nose and throat than are usual, as have workers in particle-board sawmills… Formaldehyde is classifed as a probable human carcinogen by the U.S. Environmental Protection Agency and as a known human carcinogen by the International Agency for Research on Cancer.
Sodium Deoxycholate
Sodium Deoxycholate is a water soluble ionic detergent/bile salt which causes cell death and symptoms such as burning, redness, and swelling. It has been shown to weaken the blood-brain-barrier (BBB) and subsequently activate seizures. It has demonstrated synergistic toxicity with antifungal drugs.
Detergents and emulsifiers promote tumors and cause cells to leak or explode by weakening their walls, with no mechanism for regulating destructive activity. These chemicals are not completely purified out of the final vaccine product, so they enter the body at the time of injection.
Detergents are used extensively in cell research precisely because of their ability to break cells open for further analysis. This catastrophically mimics the membrane attack complex (MAC). Detergents hit cells at random and continue destroying cells regardless of which call off the attack.
Sodium Deoxycholate is completely foreign to the relationships that define and make up the delicate balance of the immune system. It systematically disrupts these relationships to negate the optimal function and design of immune responses.
Thimerosal
Thimerosal has powerful and damaging effects on cells of the nervous and immune systems in mammals including humans. Its effect may vary depending on the dose, the genetics of the individual, and the timing of exposure. The mercury dose from thimerosal produces acute and often deadly ethylmercury blood levels.
Organic forms of mercury are well-known neurotoxic agents
and far more dangerous than inorganic mercury sources. Exposure to organic mercury produces predominantly central nervous system (CNS) effects that are commonly severe and can induce prolonged unconsciousness, coma and death. (See: Acta Chim. Slov. 2004, 51, 361-372)
After only 2 hour exposures, thimerosal at micromolar concentrations causes neuronal membrane damage and alterations leading to cell death in immune T-cells.
Thimerosal alters the functioning of critical neurotransmitters necessary for proper brain functioning.
Thimerosal causes DNA fragmentation of neuronal cells and disrupts
neuronal growth factor signaling at micromolar and even nanomolar concentrations. It also causes DNA methylation and attentional
pathways at nanomolar concentrations, leading to alterations in brain function.
Under microscopic magnification the following video presentation by the University of Calgary demonstrates the immediate damage mercury does to the structure of brain cells.
75 Studies Demonstrating the Toxic Effects of Thimerosal and Mercury
National Center For Biotechnology Information
* Toxicity of Thimerosal
* Poisoning of Thimerosal
* Adverse Effects of Thimerosal
Squalene in AS03 adjuvant
Too dangerous for human use, Squalene is not officially licensed for use in the United States or Canada. Oil adjuvants like squalene have been ordinarily used to inflict diseases in animals – for experimentation and study. According to anthrax vaccine expert Gary Matsumoto and other reliable sources, the US military used an unlicensed, experimental anthrax vaccination laced with squalene, with disastrous consequences, including Gulf War Sydrome.
"There are now data in more than two dozen peer-reviewed scientific papers, from ten different laboratories in the US, Europe, Asia and Australia, documenting that squalene-based adjuvants can induce autoimmune diseases in animals, observed in mice, rats, guinea pigs and rabbits. Sweden's Karolinska Institute has demonstrated that squalene alone can induce the animal version of rheumatoid arthritis. The Polish Academy of Sciences has shown that in animals, squalene alone can produce catastrophic injury to the nervous system and the brain. The University of Florida Medical School has shown that in animals, squalene alone can induce production of antibodies specifically associated with systemic lupus erythematosus" writes Matsumoto.
Oil-based vaccination adjuvants like squalene have been proved to generate concentrated, unremitting immune responses over long periods of time according to a 2000 article in The American Journal of Pathology. The study demonstrated that a single injection of the adjuvant squalene into rats triggered a chronic, immune-mediated joint-specific inflammation, also known as rheumatoid arthritis. The researchers concluded the study raised questions about the role of adjuvants in chronic inflammatory diseases.
Squalene Adjuvant Toxicity in Animals
National Center For Biotechnology Information
* Toxicity of Squalene
* Adverse Effects of Squalene
Polysorbate 80
Polysorbate 80 is similar to Sodium Deoxycholate in its ability to increase cell permeability, damage, and bursting. After injection it can rapidly metabolize into sorbitol and ethylene oxide which is much more toxic than the original chemical. When Polysorbate 80 breaks down there are 20 moles of ethylene oxide for every mole of sorbitol. These polysorbates have been shown to cause dangerous, sometimes fatal effects, when given through a needle. Changes in heart function can occur immediately. The blood-brain-barrier (BBB) can be weakened and penetrated, followed by seizures and even death. Polysorbates demonstrate synergistic toxicity with a wide range of chemicals.
Polysorbate 80 has been found to negatively affect the immune system and cause severe anaphylactic shock which can kill. According to Annals of Allergy, Asthma and Immunology, Volume 95, Number 6, December 2005 , pp. 593-599(7), "it is of current relevance as a 'hidden' inductor of anaphylactoid reactions", and "Polysorbate 80 was identified as the causative agent for the anaphylactoid reaction of nonimmunologic origin in the patient. The study included a pregnant woman who suffered anaphylactic shock after being given a IV drip of multi-vitamins containing polysorbate 80.
In addition to this, there have been studies in Food and Chemical Toxicology which showed that Polysorbate 80 causes infertility. Baby female rats were injected with polysorbate 80 at days 4-7 after birth. It accelerated the maturing of the rats and caused changes to the vagina and womb lining, hormonal changes, ovary deformities and degenerative follicles.
According to the World Intellectual Property Organization, which is part of the United Nations, scientists from the organization are developing vaccines specifically to damage fertility as a method of contraception. A suggested ingredient for the vaccine is Polysorbate 80 (also known as tween 80). As it is a preferred ingredient, scientists are obviously aware of its ability to cause infertility.
National Center For Biotechnology Information
* Toxicity of Polysorbates
* Poisoning of Polysorbates
* Adverse Effects of Polysorbates
Discussion
There are currently NO clinical trials or results which have validated the long-term safety and efficacy of the Arepanrix H1N1vaccine and its integrated AS03 adjuvant. Regulatory health agencies are refusing to acknowledge this fact or the nature of toxicity levels associated with Arepanrix and its ingredients. The well documented toxicity evidence for each ingredient presented above is simply being ignored.
A simple search on the ClinicalTrials.gov website shows that three "Rapid Evaluation" studies for Arepanrix H1N1vaccine have not even initiated recruiting as of the date this article was published.
One of the most critical elements which defines the toxicity potential of any vaccine are its pharmacokinetic properties. GlaxoSmithKline (GSK) and Health Canada do not consider the study, analysis or evaluatation of the pharmacokinetic properties of any vaccine including Arepanrix. This means that the bodily absorption, distribution, metabolism and excretion of ingredients within the Arepanrix vaccine are not known or even considered in safety assessments. This in itself is a highly suspicious and negligent behavior which leaves many questions on the credbility and reputability of GlaxoSmithKline and Health Canada and their motives for marketing this vaccine to the Canadian population.
Adults aged 18-60 years:
Dosage recommendations of 0.5ml are based on very limited clinical evidence of safety and immunogenicity data available from two 3-week studies. Neither study has validated the long-term immunogencity, safety, toxicity, or pharmacodynamics of the vaccine based on any dosage.Clinically, the shortest acceptable period to study the side effects of any vaccine is 6-8 weeks. The accepted studies noted by GSK and Health Canada are half this period.
Elderly (>60 years):
No clinical data are available for Arepanrix H1N1 in this age group including the effects of the AS03 squalene adjuvant. There is no data to justify any safe dosage in this age group.
Children and Adolescents aged 10-17 years:
No clinical data are available for Arepanrix H1N1 in this age group including the effects of the AS03 squalene adjuvant. No exact dosing recommendations can be made.
Children aged from 6-35 months:
No clinical data are available for Arepanrix H1N1 in this age group including the effects of the AS03 squalene adjuvant. No exact dosing recommendations can be made.
Pregnancy and Lactation
No data have been generated in pregnant or breast feeding women with Arepanrix nor with the AS03 adjuvant.
Fertility & Sterility
GSK suggests animal studies have not demonstrated harmful effects with respect to fertility which directly contradicts several scientific studies which show that Polysorbate 80 causes infertility.
Interactions With Seasonal Flu Vaccines
GSK claims that no data is available on the concomitant administration of Arepanrix H1N1 with other vaccines, including seasonal influenza vaccines.
A study based on research in British Columbia, Ontario and Quebec, has shown that people who received the seasonal influenza vaccine last year are at greater risk of contracting the H1N1 flu this year.
Adverse reactions may be intensified with co-administration with other vaccines.
Despite the suggested evidence in unpublished studies that seasonal flu vaccines can increase the risk of H1N1 flu, Canadian provinces are recommending co-administration of both vaccines in as little as 60 days. This highly irresponsible recommedation by public health officials could potentially devastate the health of millions of Canadians. An example of the schedule of shots in Ontario is listed in the chart below released in a leaflet to all Ontarians in early October 2009.
The people in Ontario need to call the ServiceOntario INFOline at
1-800-476-9708 and request information as to why Ontario is contradicting studies which demonstrate the risks of administering both the seasonal flu and H1N1 vaccine within short periods.
In addition, the Government of Ontario (and Canada) need to respond to direct queries from the public to justify why and how recommendations are being be made to administer the H1N1 vaccine to those receiving the seasonal flu vaccine, when the studies that test the safety and efficacy for the "Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine" have not yet started as of late October 2009 (with no participants even being recruited).
Adverse Reactions
Solicited adverse reactions were reported more frequently in the H1N1+AS03 group compared to the H1N1 group based on 2 studies which evaluated the safety of another AS03-adjuvanted vaccine containing HA derived from A/California/7/2009 (H1N1)v-like (Pandemrix) in healthy subjects aged 18-60 years.
Since 48.6 of the 50.4 million doses of Arepanrix ordered by the Canadian government contain the AS03 adjuvant, we will focus on those adverse reactions documented which are as follows:
- Pain
- Redness
- Swelling
- Fatigue
- Headaches
- Arthralgia (joint inflammation)
- Myalgia (muscle inflammation)
- Shivering
- Sweating
- Swollen lymph nodes
- Fever
- Vomiting
- Tingling or numbness of the hands or feet
- Shortness of breath
- Vasculitis (inflammation of the blood vessels)
Serious adverse reactions are as follows:
- Blood and lymphatic system disorders (lymphadenopathy)
- Psychiatric disorders (insomnia)
- Nervous system disorders (dizziness, paraesthesia, inflammation of the central nervous system, inflammation of nerves, autoimmune disorders affecting myelin sheaths of nerves such as Guillain-Barré Syndrome)
- Ear and labyrinth disorders (vertigo)
- Respiratory, thoracic and mediastinal disorders (dyspnoea)
- Gastrointestinal disorders (nausea, diarrhea, abdominal pain, vomiting, dyspepsia, stomach discomfort)
- Skin and subcutaneous tissue disorders (pruritus, rash)
- Musculoskeletal and connective tissue disorders (back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity)
- General disorders and administration site conditions (bruising, asthenia, chest pain, malaise)
Disturbing Concentrations of Squalene
The average quantity of squalene injected into the US soldiers abroad and at home in the anthrax vaccine during and after the Gulf War was 34.2 micrograms per billion micrograms of water. According to studies, this was the cause of Gulf War syndrome in 25% of 697,000 US personnel at home and abroad.
The soldiers developed a cascade of reactions including arthritis, fibromyalgia, lymphadenopathy, rashes, photosensitive rashes, malar rashes, chronic fatigue, chronic headaches, abnormal body hair loss, non-healing skin lesions, aphthous ulcers, dizziness, weakness, memory loss, seizures, mood changes, neuropsychiatric problems, anti-thyroid effects, anaemia, elevated ESR (erythrocyte sedimentation rate), systemic lupus erythematosus, multiple sclerosis, ALS, Raynaud’s phenomenon, Sjorgren’s syndrome, chronic diarrhea, night sweats and low-grade fever.
The AS03 adjuvant in the Arepanrix H1N1 vaccine contains 10.69mg per dose. This corresponds to approximately 2.136.0000 microgrammes pr. billion microgrammes of water, i.e. one million times more squalene per dose than the anthrax vaccine.
How much more evidence is necessary to convince public health officials that the risks of the Arepanrix H1N1 vaccine exceed any benefits?
Please do not play roulette with your health. Do not listen to the Public Health Agency of Canada or any public health or medical official that advises you to protect yourself from the flu with this vaccine. Its design and toxicity will only destroy your health.
Dave Mihalovic is a Naturopathic Doctor who specializes in vaccine research, cancer prevention and a natural approach to treatment.
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