Canada is Rushing Approval
For Untested H1N1 Vaccines
Ontario Health Minister David Caplan urged Ottawa yesterday
to speed up approval of untested
H1N1 vaccines amid fear-hyped concerns that a second wave
of the swine flu may have already arrived in the province.
Ontario is equipped to deploy the vaccine quickly, but the province
can't get it until Health Canada issues a licence to the manufacturer,
Production of the vaccine by GlaxoSmithKline in Ste-Foy, Que.,
is largely complete, he said.
The federal government wants to make sure the flu shots are safe
and effective and, as a result, Caplan said it could take three
weeks just to get the necessary approvals in place.
This news comes despite a plethora of evidence suggesting trials,
that were just initiated a few months ago, have no conclusive
evidence of safety and efficacy.
According to infectious disease experts, due to delayed and potentially
serious side effects, such as paralysis and neurological disorders,
the timelines for effective safety testing on adjuvanted vaccines
should span years from initial clinical trials.
Just over a month ago, a Canadian
health expert called for compensation for flu-vaccine injuries.
This and other initiatives by health protection advocates prompted
the government of Canada to enact protection
measures for vaccine maker GlaxoSmithKline and shield them from
all lawsuits. Health practitioners including all Physicians
will not be included in this measure.
"I'm urging the federal government to show some leadership
and, as we're seeing in the United States, expedite the approval
process so that we can get (the vaccine) deployed as quickly as
we possibly can," he said.
"But unfortunately, that's beyond the control of provincial
It may already be too late to prevent the spread of the virus
in the general population, said one expert.
"Ideally, the vaccine would have been available in September,"
said Kumanan Wilson, Canada research chair in public health policy
at the Ottawa Hospital Research Institute.
Accelerating the approval process may actually deter people from
rolling up their sleeves for a swine-flu shot over fears that
it isn't safe, he said.
"Just having the vaccine available isn't going to be enough
if nobody's going to take it," he said.
PreventDisease.com recently reported that Ontario
H1N1 flu propaganda kits in attempt to control opinion and
convince the public of vaccine and drug safety.
Surveys have shown that people are leery of the vaccine, a perception
that may have been reinforced by an unpublished
study which suggested that people who got a seasonal flu shot
last year had double the risk of catching swine flu compared with
Despite this study gaining international recognition from reputable
scientists, the Public Health Agency of Canada has said a preliminary
analysis of that study suggests there is no link between having
a seasonal flu shot and developing a severe case of pandemic flu.
There is a great deal of confusion about the vaccine and how
bad an H1N1 pandemic could be, Wilson said.
"Rushing the vaccine to market even if it's completely
legitimate and appropriate there will be segments of the
population that perceive that in a very negative light,"
That perception could change, however, if there is a sudden spike
of serious cases and H1N1-related deaths, he added.
A resurgence of the swine flu is expected this fall, but Ontario
officials don't yet know for sure whether it has already arrived.
Other parts of the world have seen several waves of the swine
flu, so provincial officials are closely monitoring the situation
here, Caplan said.
"Of course we won't know until actual testing, or there
is evidence of it," he said.
Caplan's comments come after a published report quoted a senior
Ontario health official as saying the second wave may be here.
Dr. Donald Low, head of the public health laboratories with the
Ontario Agency for Health Protection and Promotion, said a number
of flu cases have come to emergency departments over the last
The flu activity is concentrated primarily in Toronto, Hamilton
and London, said Low, who is also chief microbiologist at Toronto's
Mount Sinai Hospital.
He said there have been few cases of H1N1 in Ontario over the
last few weeks, but on Monday, six new cases were confirmed.
Provincial labs have seen a sharp increase in influenza A cases
and further testing is expected to determine that they are the
H1N1 strain, Low said.
health officials in British Columbia were already caught advising
doctors to assume that all flu symptoms are the results of the
H1N1 virus, a malicious attempt to manipulate the data.
David Jensen, a spokesman for the Ministry of Health, wouldn't
confirm Low's figures. An updated list of flu activity in the
province will be available Friday, he said.
Neither Low nor Dr. Arlene King, Ontario's chief medical officer
of health, were available for comment.
Dr. Barbara Yaffe, director of communicable disease control and
associate medical officer of health for Toronto Public Health,
told CTV News that Toronto had three confirmed cases this week,
without specifying what laboratory analysis were used to verify
whether the cases are H1N1 at all.