Canada will have a pandemic vaccine by early next month, and could speed up delivery to Canadians if the swine-flu virus turns more severe in the fall, the country's chief public-health officer says.
David Butler-Jones's comments run contrary to the federal government's insistence that Canadians should not expect to be immunized until mid-November, and follow a rash of criticism that Canada is lagging behind other countries in vaccine delivery.
The Canadian Medical Association Journal took a swipe at Ottawa this week, accusing it of delaying the rollout of the H1N1 vaccine. The governments of Australia, the United States and several European countries are planning to immunize their citizens with a vaccine starting in October.
But Health Canada's decision to fortify vaccine with adjuvants – chemical boosters that can increase production – will mire the vaccine in a time-consuming regulatory process, the CMAJ said in an editorial.
But Dr. Butler-Jones insisted Wednesday that the timing for approving an adjuvant vaccine would be the same as a non-adjuvant drug. Rolling out the vaccine in mid-November appears to be a more cautious stand.
“We will have vaccine available in early October produced. The question is do we have enough information to be comfortable with immunizing at that point or not? If the next phase of the pandemic comes much earlier than we expect, or is much more severe than we've seen, then that changes the equation,” Dr. Butler-Jones said in an interview.
“If we've got reasonable data on safety and effectiveness and we're seeing a worsening disease, then we can move up when we start immunizing, if that's appropriate.”
Canada has ordered 50 million doses from GlaxoSmithKline, which is contracted to produce the vaccine for all Canadians. While other countries are rolling out non-adjuvant vaccine for high-risk groups, Canada has decided to blanket the country with an adjuvant vaccine.
One of the main reasons behind Canada's strategy is because non-adjuvant vaccine didn't work as well in the clinical trials in protecting people against the H5N1 avian flu strain. Adjuvants are in many common vaccines in Canada, but have not previously been approved for influenza vaccines.
Critics have suggested Canada roll out a non-adjuvant vaccine much earlier to vulnerable groups, including children, pregnant women and aboriginal communities. They also say the reason for the initial mid-November timeline for the vaccine is because Ottawa was slow off the mark in placing an order with GSK, and its regulators are overly cautious.
“We don't know when H1N1 is going to hit but ... [we] have to be ready for the worst-case situation,” Liberal MP Marc Garneau said. “At the moment, because of regulatory processes with this government, because they haven't really realized the urgency of what is happening, it is possible that H1N1 could hit us early and high-risk patients will not have access to this very important vaccine.”
Attending a conference in Winnipeg on the virus, Dr. Butler-Jones said the criticism that Canada is not prepared for a resurgence of the virus this fall is unfounded. He said production has begun for the H1N1 vaccine, now that the seasonal-flu vaccine is ready and being shipped across the country.
“We have production capacity in Canada to address the whole population's needs,” Dr. Butler-Jones said. “We are moving the research and regulatory [process] and production as quickly as possible in order to get there.”
With a report from Jane Taber in Sudbury
