Canadian health officials continued to fend off criticism Wednesday over the timing of Canada's swine flu vaccine, saying the plan to roll out vaccination programs in early November still holds.
"Let me be perfectly clear: in early November we will have a safe and effective vaccine that will begin rolling out to all Canadians who want and need it," Health Minister Leona Aglukkaq said Wednesday.
"It is a vaccine that can be administered to both healthy Canadians and those with underlying medical conditions."
But with vaccination beginning in the U.S., and program rollout slated for next week in Europe, officials here are being asked why Canadians don't yet have access to a vaccine, even as flu activity begins to increase.
What's more, they're being asked by Canadian trials to test the safety and effectiveness of the vaccine have not even begun.
Canadian researchers have told Â鶹´«Ã½ that they are still waiting approval to begin trials. But Canadian officials say the vaccine will be rolled out without data from those Canadian trials, because they will have safety data from similar trials in Europe.
"Certain media reports have wrongly drawn a connection between the timing of vaccine availability and the timing of clinical trials in Canada," Aglukkaq told reporters in a news conference. "There is no delay in the vaccine."
The supporting safety and efficacy data upon which Canadian vaccine authorization will be based on international clinical trials, she said.
Vaccines are routinely approved in Canada without domestic clinical trials. In this case, the antigen --the "pure vaccine" -- has been tested in other trials around the world. And the adjuvant -- the added compounds that boost immune response -- has been tested on tens of thousands using the H5N1 avian flu strain.
Canada's Chief Public Health Officer Dr. David Butler-Jones has said the only thing different between the vaccine tested in Europe by Canada's contracted pandemic vaccine supplier, GlaxoSmithKline, and that to be tested in Canada is that they are being made in different manufacturing plants.
He noted Wednesday that the clinical trials in Europe were able to start earlier because "they had a bit of a headstart on production." That's because they were able to produce seasonal flu vaccines at the same time as swine flu vaccines. In Canada, our contracted pandemic vaccine supplier, GlaxoSmithKline, needed to complete work on seasonal flu vaccine first.
Overall, the Canadian clinical trials will test the vaccine on tens of thousands of people, Butler-Jones said Wednesday, though much of that testing will happen during the so-called post-market period, after vaccination programs have begun.
As for why Americans are beginning to get vaccinated this week, Butler-Jones noted that the vaccine unveiled this week in the U.S is an inhaled vaccine, which has never been approved in Canada and is not suitable for those most at risk because it contains a live virus.
"The fact that they have access to the vaccine is nice... That's a useful thing, but it's in small amounts, for a small number of people and not those at greatest risk of serious disease," Butler-Jones said.
He reiterated that the plan is to make sure the vaccine is available for every Canadian who wants it. "This is the largest immunization plan in history, we have to get it right," he said.
He also noted that while the swine flu virus seems to be spreading in the southern U.S., in Canada, we have so far only seen a few clusters of outbreaks.
"Right now in Canada, unlike in the United States, we are not seeing widespread influenza activity," he said. "We're many weeks behind the Americans in terms of rates of disease."
