The Globe and Mail

Dissent over Canada's H1N1 vaccination strategy continued to quietly mount in the country's medical community Tuesday as the top public health official announced the government will temporarily leave nearly 1 million doses of the vaccine on the shelf till early November.

The decision to hold off comes at a time when the pandemic flu is on the rise in places like British Columbia and high-risk individuals across the country could face severe disease and little protection.

Other countries, including the United States, Australia and China, have already begun inoculating their populations against the swine-flu virus.

Some health experts fear that the late rollout in Canada could come just as the virus begins to peak – and that the vaccine, awaiting regulatory approval, will do little to save those groups most vulnerable to the influenza pandemic, including pregnant women.

David Butler Jones, Canada's chief public health officer, said the vaccine needs to be tested for its safety and effectiveness before being rolled out to Canadians. “Immunizing a small number of people will not stop the effects of the pandemic,” he said Tuesday.

Pressed by reporters on Canada immunizing its citizens in early November instead of sooner, he responded: “There is no delay. The vaccine is just starting to come out of quality-testing. Provinces and territories are doing all the work to put it in place. So that rather than piecemeal, you can deliver an effective vaccine campaign for the whole country.”

Anand Kumar, an intensive-care specialist at Winnipeg Health Sciences Centre, acknowledged that rolling out the vaccine piecemeal won't stop the pandemic. “But it will protect the highest risk people from getting severe disease,” he argued.

Dr. Kumar co-authored a Canadian study in the Journal of the American Medical Association that revealed a disturbing number of young, otherwise healthy women fell critically ill and died of H1N1 influenza. The study found that a large majority of those who became seriously ill had no serious underlying health conditions. Two-thirds of patients admitted to Canadian intensive care units were women. The average age was 32. That is in stark contrast to seasonal flu, which mainly burdens the elderly.

“Personally, I don't feel that a lot of testing is warranted given the fact that this is a variation of vaccines that have been used for the last 10 years,” Dr. Kumar said. “The faster we get the vaccine out and get the communities covered, the better we're going to do.”

Canada's vaccine, produced by GlaxoSmithKline at its plant in Ste-Foy, Que., has yet to be approved by Health Canada – and it won't be distributed until the approval process is complete, even though that is considered largely a formality. Ottawa has ordered 50 million doses of the H1N1 vaccine from GSK.

Dr. Butler Jones hinted that Canadians could be offered the H1N1 vaccine at the end of this month, if Health Canada moves through the regulatory hurdles quickly. But he said the first week of November is still the target date for the vaccine launch.

While other countries are rolling out non-adjuvant vaccine, Canada has decided to fortify its vaccine with adjuvants, which are chemical boosters that can increase production. Adjuvants are in many common vaccines in Canada, but have not previously been approved for influenza vaccines. But components of the vaccine have been proven to be safe: The adjuvant has been tested on thousands with the H5N1 avian flu drug, and the antigen has been tested in other trials in the U.S. and elsewhere.

Dr. Butler-Jones said the early November timeline is based on the availability of the vaccine, and the ability of provinces and territories to smoothly move from administering seasonal flu shots to the H1N1 vaccine.

The Health Minister, he said, will authorize the use of the vaccine once there's sufficient evidence on its safety. Results from further clinical trials will be released later this week.

About 4,500 people worldwide have died of H1N1, including 79 in Canada. Hundreds of thousands have been infected, but many countries have stopped counting cases because the disease is so widespread.