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Canada Approved H1N1 Vaccine Without Evaluating Safety on a Single Canadian

Health Canada approved the H1N1 vaccine without evaluating its safety and effectiveness on a single Canadian.

Instead, the federal drug regulator approved the Arepanrix pandemic vaccine based on the results of a small clinical trial in Belgium.

The study involved 130 healthy adults, aged 18 to 60, who were inoculated with the same version of Arepanrix, which is produced by GlaxoSmithKline, the sole vaccine manufacturer for Canada.

The vaccine used in the Belgian study was manufactured by GSK in Germany. Canada's vaccine is produced in Ste-Foy, Que.

Health Canada officials released the information late Friday, in response to increased pressure from various media outlets about what scientific evidence was used to establish the safety and effectiveness of the H1N1 vaccine.

Canada's largest-ever immunization campaign began in late October after the federal government rushed approval for a vaccine.

"Data from a clinical trial conducted in Belgium, using the same version of the vaccine produced by GSK in Dresden, Germany, was reviewed, as was initial safety data from European and Japanese studies using the Quebec-produced vaccine Arepanrix," Health Canada spokeswoman Christelle Legault said in an e-mail.

Legault did not indicate how many volunteers participated in the Japanese or European studies that used the Quebec-made vaccine.

To date, Health Canada has not reviewed any data from the clinical trials being conducted in this country, said Legault.

"Canadian clinical trials, which began in October, will be used as part of ongoing work to evaluate the vaccine's safety and effectiveness in larger and more specific populations, after the vaccine authorization takes place," said Legault.

Health Canada surprised many observers by approving the pandemic vaccine two weeks ahead of schedule. Since then, several questions have been raised about precisely what information went into evaluating the vaccine.

A simple search on the website shows that three "Rapid Evaluation" studies for Arepanrix H1N1vaccine have not even initiated recruiting as of the date this article was published.

Opposition parties have called on federal Health Minister Leona Aglukkaq to make public the medical evidence used to determine the safety of the H1N1 vaccine to reassure Canadians that no short cuts were taken in the race to test and produce the pandemic flu shot.

At a news conference Friday, Aglukkaq said Health Canada approved the vaccine ahead of the initial target of early November because "the international community was able to share their clinical data and work with us." As a result, "we had all the data that was necessary to make an informed decision on the safety and effectiveness of the vaccine by Wednesday," said Aglukkaq.

NDP health critic Judy Wasylycia-Leis said she has repeatedly pressed Aglukkaq for the H1N1 safety data, but has not received a response.

"I was told all documents and studies around vaccines are transparent and fully available. I haven't found them yet, and I'm still looking. So that is the big concern," said Wasylycia-Leis. "Where's the hard scientific evidence showing that (they) have done the tests, independent of the drug companies?Where is the body of evidence that they're citing?"

The questions are being raised because Canadian scientists, who started testing the Glaxo vaccine last week, have indicated that it could take up to seven weeks to collect the early results from Canadian test subjects.

The federal regulator also examined data on the safety and effectiveness of GSK's AS03 squalene adjuvant, a chemical derived from fish oil that boosts the vaccine's effectiveness.

The H1N1 vaccine is the first time Canada has approved a flu shot with the squalene adjuvant in it, which is currently unlicensed and not regulated by any province in Canada.

* A full list of h1n1 vaccine ingredients, alerts and warnings.

The Public Health Agency of Canada
Is Already Hyping The 3rd Wave of Flu

Canadian H1N1 Clinics Closing
Due To Decreased Demand

Push Is On To Continue Vaccinating
Everyone For H1N1 Swine Flu

Report: 36 Canadians Suffer Severe
Allergic Reactions While 200 Others Died

Surge in Anaphylactic Shock In B.C. As More People Report Reactions To H1N1 Vaccine

Canada Sets Aside 170,000 Doses of the Arepanrix H1N1 Vaccine After Reactions

Health Canada Warns Canadians To Stay Away From Natural Medicine To Fight H1N1

Canadian Councillor Representing Ottawa Wants Military To Conduct Vaccinations

Canadian Press Reports On
Depopulation and H1N1 Vaccine Fears

More Canadian Propaganda:
Hyping H1N1 Vaccine Scarcity

Canada Approved H1N1 Vaccine Without Evaluating Safety on a Single Canadian

Canadian Government Orders Surveillance
of Public Transportation For Swine Flu

Toronto Public Health Officials Use Tragic Death of Teenager To Promote H1N1 Hype

ALERT Canadians: Toxic Ingredients in the Arepanrix H1N1 Vaccine Harm Your Health

Canadian Health Officials Struggle To Counter What They Consider H1N1 Myths

Canada Decides To Approve
Unlicensed Adjuvanted Vaccines

Canadians Will Be Immunized Faster
Than Other Parts of the World

Impending Mandatory Vaccinations Will Affect The Health, Jobs of Canadians

Public Health Officials in Canada Engaged
in Cover-Up Operation To Conceal Flu Origin

Canadian Province May Suspend Flu
Shots After Vaccine's Safety Questioned

Canada's Largest Province Distributing
H1N1 Flu Propaganda Kits

Canada Plans To Vaccinate The Entire
Population Against H1N1 Swine Flu

Canadian Medical Journal, Population Health Expert Call For Greater Pandemic Powers

Canadians Will Be Inoculated With H1N1 Vaccine Before Trials Are Completed

Canada is Rushing Approval
For Untested H1N1 Vaccines

Forced Vaccination and
Quarantine Laws in Canada

Targeted Native Populations in Canada
Dying of Tamiflu and Antiviral Intoxications

Health Expert in Canada Calling For
Compensation For Flu-Vaccine Injuries

Reference Sources: 210,
November 2, 2009


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