Canada Decides To Approve Unlicensed Adjuvanted Vaccines

Prevent Disease
Oct. 22, 2009

Canada's largest-ever immunization campaign is about to get underway after the federal government rushed approval for a vaccine that could be administered to the population in as little as a week.

Health Minister Leona Aglukkaq's office confirmed Wednesday an announcement would be made allowing provinces and territories to proceed with H1N1 flu vaccinations as soon as possible.

It's Approved

"It's officially approved," said Tim Vail, a spokesman for Aglukkaq.

The Public Health Agency of Canada had said it was aiming to have the vaccine available in early November.

Other countries have already begun vaccinations. The United States has started giving swine-flu shots to people in groups thought to be at greater risk.

Japan started its vaccinations Monday and Britain started Wednesday.

Two million doses of the swine-flu vaccine have already been shipped to the provinces and territories to await final sign-off from Ottawa.

The government aims to ship around three million doses a week as the vaccine rolls off the production line.

The vaccine needed regulatory approval before the federal government could give the provinces and territories the green light to start the H1N1 flu shots.

Canadian clinical trials are still underway, but federal health authorities are relying on data from clinical trials done in Europe.

Pharmaceutical giant GlaxoSmithKline has a contract to produce 50.4 million doses of pandemic vaccine at its facility in Ste-Foy, Que.

Can You Do The Math?

There are concerns about the new vaccine, which contains adjuvants, or compounds that are claimed to boost the immune system's response to vaccines.

There's currently no licensed flu vaccine containing adjuvant in Canada and there are no data on the use of so-called adjuvanted flu vaccine in pregnant women, which may add to the already high degree of reluctance many pregnant women feel about taking any medication or therapy.

There is also little data on the safety of the additives in vaccines given to children.

Though it had first said it would only buy adjuvanted vaccine, the federal government later ordered 1.8 million doses of vaccine that does not contain adjuvants for pregnant women and young children. But the doses shipped this week contain adjuvants.

The population of Canada may want to pay special attention to the fact that there are no licensed flu vaccines containing adjuvant in Canada. Yet only 1.8 million of the 50.4 million doses do not contain adjuvants. That means that potentially 95% of the Canadian population will receive adjuvanted vaccine contradicting Canadian health regulations as mandated by Health Canada.

The vaccine without adjuvants needs to be formulated and packaged separately from the adjuvanted vaccine, which is why they are being shipped separately, said Canada's chief public health officer, Dr. David Butler-Jones.

The Public Health Agency hasn't said when the vaccine without adjuvants will be shipped.

* A full list of h1n1 vaccine ingredients, alerts and warnings.