Canada Decides To Approve
Unlicensed Adjuvanted Vaccines
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
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 officially approved," said Tim Vail, a spokesman
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
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,
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
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.