How Health Canada tracks and analyzes COVID-19 vaccine side effects

Two professors with backgrounds in clinical trials say Health Canada's monitoring system for side effects is built with layers of redundancy to ensure nothing is missed. Xiaoli Li has more on how Canada is tracking COVID-19 vaccine side effects.

By CityNews staff

OTTAWA (CityNews) — It usually happens behind the scenes, but Canadians are now trying to learn more on how Health Canada monitors new biologics and medicines for side effects.

Greg Staios and Frank Merante teach at the School of Biological Sciences and Applied Chemistry at Seneca College in Ontario. Between them, they have decades of experience bringing new medical products through clinical trials.

The two say Health Canada’s system has redundancies built in, aimed at ensuring no safety issue is missed.

“Quality is like Swiss cheese,” said Staios. “What you do is, you have various different layers of Swiss cheese lined up against each other. And so you can envision that there might be one thing gets through one slice of Swiss cheese, but another slice of Swiss cheese is going to be able to catch it when it gets through.

“So there’s definitely a significant oversight and a variety of different mechanisms that exist to ultimately ensure the safety of the medication.”

Staios and Merante say several different parties are responsible for reporting adverse reactions.

Manufacturers are required to track how their new medications or vaccines affect people. Local health authorities are also required to report when someone says they’ve had a bad reaction to a new drug, vaccine, or treatment.

Vaccines in particular are watched more carefully as they are given to healthy Canadians.

Merante and Staios say Canada’s international allies also have a vested interest in the vaccine and are monitoring and sharing information as well.

“The concept of cooperativity nationally, and internationally, it’s unprecedented,” said Merante. “We took a literally unknown disease virus and created a vaccine and are putting that vaccine into the arms of people, in the course of a year. I think that’s extraordinary. And I think everybody should be proud of that accomplishment.”

While Health Canada always tracks adverse reactions to vaccines, the federal group has taken it a step further by publishing that data online for all to see. Those reactions range from soreness at the injection site, to death.

The most recent data shows 24 deaths reported among the 3.7 million people who have been vaccinated. Of those, 13 deaths were determined to be not related to a vaccine. The remaining 11 are still under investigation.

Staios says that information has always been available but not always easy to find for the general public.

“It’s been a lot more targeted,” he said. “So the key information around medications that have been approved are easier to find. Versus the normal database, where you have to go through and search it yourself.”

–with files from Xiaoli Li

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