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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, Caplan said.

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 governments."

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 is distributing
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 unvaccinated people.

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," he said.

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 few days.

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.

Public 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.

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