Saturday, November 14, 2009

Canadian Swine Flu Vaccine "Interim Order" uses identical language as US "Emergency Use Authorization"

Canada's Minister of Health, Leona Aglukkaq (a politician with no medical training) issued an "interim order" for the sale of swine flu vaccine in Canada on October 13, 2009.

Under the section titled "Authorization for Sale" are the following requirements that must be met to issue an interim order. These are:
"... it is reasonable to believe that
  1. the vaccine may be effective in providing protection against the novel influenza A H1N1 virus, and
  2. the known and potential benefits of the vaccine outweigh the known and potential risks."
What does the US regulation for an Emergency Use Authorization say?
"2. ... it is reasonable to believe that the product may be effective...

3. ... the known and potential benefits of the product outweigh the
known and potential risks ..."

What does the interim order allow? According to GlaxoSmithKline's AREPANRIX vaccine package insert:
"Health Canada has authorized the sale of the Arepanrix H1N1 [vaccine] based on limited clinical testing in humans under the provision of an Interim Order issued on October 13, 2009."
It further states that no clinical data are available for influenza vaccines with ASO3 in the 6-35 month age group. Up to 1 in 1,000 recipients may have the following side effects: seizures, anaphylaxis, painful neuropathy or thrombocytopenia (presumably on an autoimmune basis, like Idiopathic Thrombocytopenic Purpura due to the MMR vaccine). Very rare side effects that occur in 1 in 10,000 doses or less include neurological disorders such as encephalitis, neuritis and Guillain Barre Syndrome and vasculitis (autoimmune inflammation/thrombosis of multiple blood vessels).

It seems that health agencies have decided to trade cases of severe respiratory disease due to the virus for cases of neurological and autoimmune diseases due to the vaccine. This meets the legal standard specified above for the US and Canada: requiring only that the vaccine "may be effective" and that its potential benefits outweigh its potential risks. Because there has been just "limited clinical testing" one can only guess whether the potential benefits outweigh the potential risks.

Politicians seem to always prefer errors of commission to errors of omission. They can't be caught sitting on their hands, after all. Their charge is to Do Something! And furthermore, they appreciate the opportunity to spend a few billion bucks.
  • Should we thank them for this medical trade-off?
  • Will we have any drugs and vaccines left for use when they are really needed?
  • Is our northern neighbor reading from Washington's script?

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