Health Canada has authorized the sale of Arepanrix™ H1N1 vaccine based 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-?-tocopherol, squalene and polysorbate 80 in a 3mL vial:
DL-?-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).
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