U of C injects advice on flu shots

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by Alex Frazer Harrison

Clinical trials can be a slow process. It can take months to organize the research and analyze the results.

So what happens when you need to conduct an urgent safety study – and you only have six weeks in which to collect the data and analyze it?

That’s what the Canadian Association for Immunization Research and Evaluation (CAIRE) faced when it was called upon by Health Canada to conduct clinical trials to gauge possible side-effects of a flu vaccine.

Several U of C researchers were involved in the ground-breaking 2001 study.
“ In 2000, it was noticed that a higher number than usual people had reported side effects after getting flu shots, including red eyes and tightness in the throat (oculorespiratory syndrome),” says Dr. Margaret Russell, an associate professor in the Department of Community Health Sciences in the Faculty of Medicine.

The side-effects were traced to a change in how one of Canada’s flu-vaccine makers manufactured the drug in 2000. That company made the correction, but in order to ensure the vaccine set to go out in the fall of 2001 was safe, a clinical study had to be done fast, Russell says.

“ Participants had to be found, screened and treated – in just four weeks.”
The results of both studies were recently published this year in the journal Clinical Infectious Diseases.

But the data needed to give the 2001 vaccine the go-ahead was ready within the six week deadline.

“ We found that the vaccine was safe (but) some people do have adverse reactions,” Russell says. “Our findings will help make health care providers and the public more aware that the vaccines are safe but some aches and headaches could be expected.”

The findings, published in October 2003, suggests those who have experienced adverse effects from flu shots in the past should check with their doctor, but reported reactions were generally mild and are not a barrier to people being vaccinated again.

“ In our first trial of people who had not suffered effects before, no one was bothered enough by side-effects to seekmedical attention,” Russell says.
In the long term, Russell says, the fact CAIRE was, in such a short period of time, able to recruit and screen hundreds of test subjects from across Canada, gather data, and draw conclusions, will bode well the next time an urgent study of this sort is needed.

“ We know that if necessary we will be able to do the necessary safety testing (in a short period of time),” she says. “The lessons learned from doing this study will be incredibly important.”

Other U of C faculty involved in the study were Doctors H. Dele Davies, James Kellner and Judy MacDonald.

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