Rushing H1N1 vaccine for fall unethical, prof says

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This 2009 image taken through a microscope and provided by the Center for Disease Control and Prevention, shows the H1N1 strain of the swine flu virus. The swine flu epidemic crossed new borders Tuesday with the first cases confirmed in the Middle East and the Asia-Pacific region, as world health officials said they suspect American patients may have transmitted the virus to others in the U.S. (AP Photo/Center for Disease Control and Prevention, C. S. Goldsmith and A. Balish) (CP)

THE creation of a vaccine for the H1N1 virus is being rushed for late-fall distribution without the public being told that it may not work or could be harmful, a University of Manitoba professor says.

Arthur Schafer, director of the U of M's Centre for Professional and Applied Ethics, said Thursday the fall release of a vaccine cannot be done in time without a lot of doubt about its safety and effectiveness.

"It will have been tested only for a short time and only on a comparatively small sample of patients," Schafer said, adding that isn't enough time to determine it will protect the public.

"My argument is that it's wrong to lead the public to believe that the vaccine will be a 'magic bullet,'" Schafer said. "Nobody knows that. Nobody can know that." He said the public should be told about the uncertainties.

Ottawa announced Thursday that 50.4 million doses of an H1N1 vaccine will be purchased and should be ready for distribution.

Dr. David Butler-Jones, Canada's chief public health officer, said during a teleconference that clinical trials of the vaccine will be carried out in late September and the vaccine distributed across the country in November.

Butler-Jones said enough vaccine has been ordered to ensure everyone who wants or needs it can get it, adding public health officials expect upwards of 60 per cent of Canadians will be vaccinated.

Butler-Jones said the 50.4 million doses of the vaccine are enough to ensure two doses for every individual who is receiving it. If more is needed, it can be ordered in the new year, he said.

A senior official with the World Health Organization (WHO) said Thursday that fast-tracking H1N1 vaccine production will not undermine safety concerns.

But Dr. Marie-Paule Kieny said countries using a vaccine will need to be vigilant to look for and investigate any reports of adverse effects.

Schafer said the scientific research shows that the effectiveness of seasonal flu vaccines in preventing healthy people from developing the flu has been marginal. The effectiveness of antiviral drugs, designed to mitigate the effects of flu, are equally unimpressive and research shows they can have dangerous side-effects, he said.

"Good ethics requires good facts, and the ethical debate so far has been who should be the first (to get the vaccine) and there has been virtually no discussion of the safety and effectiveness of the drug."

Schafer said an independent review of the effectiveness of flu vaccines concluded that healthy adults shouldn't be taking them, adding he wonders why anyone would want to take a vaccine for H1N1 that's been rushed to the public and without proper studies to determine it's safe.

Schafer said public health officials are aware of the scientific evidence, but that he believes they and politicians are rushing a vaccine without explaining they don't know if it will work.

"The public is entitled to know that no one can be sure whether the (H1N1) vaccine will be genuinely beneficial overall," Schafer said. "No one can be sure that the benefits will outweigh the harms.

"Will the vaccine be a life-saver? Possibly, but possibly not. That's what the public needs to understand."

Meanwhile, Premier Gary Doer said all governments in Canada must make it a priority to plan for the return of H1N1 this fall.

The potential H1N1 outbreak is like "a truck coming around the corner," Doer said from the premiers' conference in Regina, adding the provinces and Ottawa must be ready with vaccine and antiviral plans, and outlines for how to handle everything from the effect an outbreak could have on hospitals and paramedics to school absences and workplace productivity.

Doer said one of his chief concerns is the low rate of regular flu vaccination among the most vulnerable in some communities. It's as low as 15 per cent in some places, he said.

That means there has to be a lot of planning now to ensure the vaccine reaches where it's most needed as soon as it's ready and that once it is distributed, it is actually given to the people who need it most.

-- With files from Mia Rabson and The Canadian Press

aldo.santin@freepress.mb.ca

Republished from the Winnipeg Free Press print edition August 7, 2009 A4