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
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.
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
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
"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
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.
full list of h1n1 vaccine ingredients, alerts and warnings.
Reference Sources: 210, www.edmontonjournal.com
November 2, 2009