Health Canada said limited non-adjuvant vaccines will be available to pregnant women.

Vaccine-risk groups, alternative medicine advocates and numerous parents and citizens are voicing concern in Canada and the United States. Locally, activist Doug Shapira has organized a "peaceful information rally" at the Grey Bruce Health Unit.

National opinion polls suggest fewer than 50% of Canadians will request the shot.

Dr. Hazel Lynn, Grey-Bruce's medical officer of health, stopped short of recommending the H1N1 vaccine for everyone. She said it will be up to each person or parent to weigh the risks of contracting H1N1 -- which people have recovered from in 99% of cases -- against concern about the shot.

"If we do, indeed, end up with a vaccine in time, I think people who are at real high risk should be immunized. It's still way safer for them to take an immunization than it is to get the disease," Lynn said. "Now, a healthy person, I guess everybody has to make up their own mind."

The federal government has ordered 50.4 million doses of the new H1N1 vaccine -- enough for every Canadian who wants it -- as part of a $400-million contract with GlaxoSmithKline. Clinical trials are expected to begin in Canada late this month in advance of a November release.

Health Canada is fast-tracking the approval process for the vaccine, due to the World Health Organization's decision to lift the H1N1 pandemic to its highest alert level.

Advertisement


As part of the accelerated review process, Health Canada will draw on clinical trial results from other countries, according to Public Health Agency of Canada spokeswoman Nadia Mostafa.

Mostafa said the "safety and effectiveness" of the vaccine will be monitored following the immunization's release and Health Canada will "ensure the timely communication of any potential adverse events."

Owen Sound-based homeopath Sue Seguin said her top concern is the use of an adjuvant in the H1N1 vaccine and its risk to people, especially children.

Adjuvants boost a vaccine's active ingredient and a person's immune response, so less antigen is required.

Health Canada refused to specify the type of adjuvant used in its vaccine, citing "proprietary information."

Dr. Lynn said she hopes GlaxoSmithKline will use the adjuvant aluminum salt, which is the only one ever used in Canada. The compound has produced very few complications in its 70- year history, she said.

"We don't know what the vaccine (contains), so if it was a brand new adjuvant that no one's ever used before, I'd be cautious," she said.

Lynn said she expects to learn the contents of the vaccine within the next few weeks.

Seguin and others fear Glaxo- SmithKline will add the newer, fat-based adjuvant, squalene, to the serum.

Squalene was present in the anthrax vaccine injected into Gulf War soldiers. It has been linked to the so-called Gulf War Syndrome, which produced multiple symptoms -- from memory problems to chronic illness -- in thousands of soldiers. The link has never been proven and many health experts believe contamination was behind the syndrome.
The WHO said experts reviewed the safety of adjuvants in June and identified "no significant safety concerns."

Seguin said she is also concerned the vaccine preservative thimerosal -- which contains high levels of mercury -- or formaldehyde will be used in the serum.

"If they do show up in the vaccines for Canadians, that changes the weight of the decision that Canadians have to make," she said.

Severe side effects to swine flu vaccines were recorded in the United States in the 1970s when elevated rates of autoimmune disorder Guillain-Barre syndrome were found in people who received the injection, according to Canadian health agencies. Thirty people died. About one person per thousand were diagnosed, which halted the vaccine campaign.

The World Health Organization said there is no guarantee a similar risk will not emerge this time.

"However, the influenza A (H1N1) vaccine will be manufactured according to established standards and post-marketing surveillance will be conducted to monitor potential development of any serious adverse events following administration of vaccine," the WHO said in a statement.

Groups such as the Canadianbased Vaccine Risk Awareness Network are calling on Health Canada to list all components of the H1N1 vaccine and possible risks of each.

"We want people to know and understand the potential health problems of this vaccine," spokeswoman Edda West said. "The other thing is, the flu vaccine is notorious for being ineffective."

The Public Health Agency of Canada said that while the H1N1 vaccine is "recommended for all Canadians who need or want it," it is optional. Each jurisdiction will organize immunization clinics.

Dr. Lynn said she does not have enough staff to hold school vaccination clinics.

Still, Seguin said she is concerned parents will feel obligated to vaccinate their children against H1N1, especially if it is added to Ontario's Immunization of School Pupils Act.

Seguin said it is important for parents to know that they can submit a conscientious objection to any or all vaccines, without risking a child's suspension.

"Your kids can go to any school they want to in Ontario without any vaccinations. That's always been the law. It's still the current law. But, they stretch it to look as though the child will be suspended without the vaccine. They will be suspended without an updated file," she said.

Dr. Lynn said the disease has been mild so far in children, so it is up to each parent. However, school children are "incubating vessels" for the virus, so parents must keep their child home to prevent an outbreak, she said.

Canada's public health agency is expected to release a priority list this month for the H1N1 vaccinations. It will likely include pregnant women and people with serious medical conditions.

Health Canada said limited non-adjuvant vaccines will be available to pregnant women.