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Canada, U.S. spark ethical debate with different approaches

Who's winning the H1N1 battle: Canada or the U.S.? How are athletes dealing with swine flu? Should I vaccinate my child? Every one has questions when it comes to this strain of influenza.

The widely divergent approaches taken by Canada and the United States on the H1N1 pandemic strategy and vaccine rollout are part of an enormous public-health experiment whose outcome is impossible to predict.

The United States has opted for unadjuvanted vaccines while the bulk of H1N1 vaccine distributed in Canada will contain immune-boosting adjuvants. South of the border, health officials are already dealing with a vaccine shortage as Canada prepares to begin inoculating the public. U.S. President Barack Obama has declared the virus a national emergency, while Prime Minister Stephen Harper has so far remained near the sidelines to allow public-health officials to advise citizens.

As the H1N1 virus becomes more widespread across North America, the differing national strategies are sparking debate and raising ethical questions about which country is taking the correct approach. It may be tempting to point fingers at this early stage, but health experts and government officials say it will be too early to draw any conclusions until well after the pandemic is over.

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Vaccination strategy

U.S. officials opted for an H1N1 vaccine made without adjuvants, which is now a household term across Canada. Adjuvants are substances that help boost the immune response of individuals receiving the vaccine. But the adjuvant being used in the H1N1 vaccine has not been approved by health officials in the United States, so it is not being added to the vaccine there.

There have been concerns that vaccines containing an adjuvant could cause Gulf War syndrome, a mysterious illness suffered by many Persian Gulf war veterans, typified by symptoms such as fatigue and loss of muscle control. But there is no scientific evidence to support that theory.

Some previous studies, involving rodents, have suggested that certain adjuvants may cause autoimmune disorders. However, health officials say the specific adjuvant being added to the H1N1 vaccine now being distributed across Canada has been used in Europe for many years, tested on tens of thousands of people and been found to be safe.

Although any vaccine comes with risks, they are "infinitesimally small" while the risks from influenza are "far, far higher," said Anand Kumar, a specialist in critically ill patients with the Winnipeg Regional Health Authority and an associate professor of critical care and infectious disease at the University of Manitoba.

"The risk-benefit here is so incredibly in favour of getting vaccinated it's not even worth considering adjuvant or no adjuvant," Dr. Kumar said in an interview yesterday.

Vaccine supply

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But adjuvants do not just boost the immune response. They also allow vaccine makers to use less antigen, the active ingredient in vaccines, meaning that they can produce significantly more vaccine - four to five times more - than would be possible without adjuvants. It's a critical point because it allows makers to produce large amounts of vaccine quickly as the virus spreads throughout a country. The necessity of being able to produce significant quantities of vaccine rapidly hit home this week as reports of major shortfalls in the United States began to emerge.

U.S. officials had said 40 million doses would be available by the end of October, but this week, less than 23 million were ready. The shortage is due primarily to manufacturer difficulty in producing the vaccine.

A front-page New York Times article yesterday described how public-health officials are having to act as "swine flu police," turning away elderly people who are not part of the risk groups being targeted for early vaccination. It also suggests that news of the shortage has led some Americans to beg or lie about being pregnant or having an underlying health condition, such as asthma, just to get vaccinated.

Weeks ago, Canadian public-health officials were under fire after reports that other countries, such as the United States, would have the H1N1 vaccine before Canada.

But now, it appears that the use of adjuvants has put the delivery of vaccine across this country on track.

"It looked initially like we were perhaps going to be too late," Kumanan Wilson, Canada Research Chair in public-health policy at the Ottawa Hospital Research Institute. "But in retrospect it looks like we may have actually made the right call."

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Communication strategy

This past weekend, Mr. Obama declared swine flu a U.S. national emergency, a designation that allows hospitals to take certain measures, such as setting up alternative sites, in order to speed treatment. That designation is part of an overarching communication strategy that is being used south of the border, said Michael Gardam, director of infectious diseases prevention and control at the Ontario Agency for Health Protection and Promotion.

"The U.S. approach has been far more aggressive," Dr. Gardam said.

By contrast, Mr. Harper has taken a more back-seat approach. When asked by reporters earlier this month if he planned on getting vaccinated, he said he would if it was recommended by health officials - a comment some critics said added to the confusion.

Instead of declaring a state of emergency, federal health officials have been trying to encourage Canadians to get vaccinated while emphasizing the need to wash hands often, avoid coughing or sneezing into the air and staying home when sick.

"Despite all of the accusations of Canada hyping this, Canada has actually been pretty cool about it," Dr. Gardam said.

But a major part of the reason for a less-aggressive public campaign is that the hands of Canadian health officials have been tied, according to Dr. Wilson. They could not encourage the public to become inoculated until the H1N1 vaccine was approved in Canada, which occurred last week. But even then, health officials are being careful about what they say because they are focusing preliminary efforts on protecting vulnerable risk groups such as young children, pregnant women and people with certain medical conditions.

"They still can't be totally saying everyone needs it right away because they've actually asked non-high-risk people to defer the vaccine," Dr. Wilson said.

But as more doses are delivered and vaccination clinics open to the general public in coming days and weeks, he suspects Canadian health experts and government officials will change their tune and perhaps adopt the U.S. tone.

"When they have enough, they're going to definitely be out there saying, 'Everyone should get this,'" Dr. Wilson said.

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