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Old 10-28-2009, 11:45 AM   #30 (permalink)
Acie
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McGeer was responding to Health Canada's decision last week to approve the H1N1 vaccine without evaluating its safety and effectiveness in a single Canadian.


Instead, the federal drug regulator approved the pandemic flu shot based on the results of a small clinical trial conducted in Belgium.


The study involved 130 healthy adults, who were inoculated with the same version of Canada's vaccine, which is produced by GlaxoSmithKline under the trade name Arepanrix.


In the race to approve the vaccine, experts say Health Canada didn't have time to wait for Canadian scientists, who started testing the Glaxo vaccine two weeks ago and indicated that it could take up to seven weeks to collect the early results from Canadian tests.


The situation stands in marked contrast to the U.S., where federally funded scientists last month published early results of their safety and effectiveness tests, weeks ahead of the vaccine's approval by the Food and Drug Administration


While large clinical trials are always more reliable, the federal drug regulator chose to move as soon as some scientific evidence was available.
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