Study to investigate effectiveness, safety of COVID-19 vaccine in children

TORONTO — The federal government is investing $1.8 million towards a Canada-wide study looking into the effectiveness and safety of the COVID-19 vaccine in children.

The study has been underway since June 1 through Canada’s Immunization Monitoring Program ACTive (IMPACT), a medical surveillance network involving 13 pediatric hospitals across Canada.

Researchers are examining the severity of symptoms in children who are admitted to these hospitals for COVID-19 infections as well as watching out for any children who report any adverse health events following vaccination.

“These studies on the effects of illness from COVID-19, and COVID-19 vaccine safety and effectiveness will help us learn more about the best ways to protect younger Canadians and their families,” said Chief Medical Officer of Health Dr. Theresa Tam in a news release on Friday.

Dr. Shaun Morris, who is a pediatric infectious disease physician at Toronto’s Hospital for Sick Children, says such studies are a “standard part” of the vaccine safety process.

“In Canada, we regularly monitor alternative vaccines to ensure that their continued safety, post licensing,” Morris told over the phone on Friday. “Canada is really a leader, actually, in post-licensing vaccine safety surveillance.”

Currently in Canada, the Pfizer-BioNTech vaccine is the only one that has been approved for children ages 12 to 17. After initially approving the vaccine for individuals 16 and over, Heath Canada cleared the vaccine for children 12 and up following a clinical trial in the U.S., which found that the vaccine was 100 per cent effective in children aged 12 to 15.

“Overall, the vaccines are safe and generate a very good immune response in the 12- to 17-year-old age group,” said Morris.

However, continued surveillance of the vaccine could shed light on any potential rare side-effects that may not have been seen during clinical trials.

“When you start using vaccines around the world in tens or hundreds of millions of people, very, very rare events, may be seen,” Morris explained. “And so that’s why it’s important for all vaccines that we monitor them after they’re licensed and being used in larger numbers than they were in (clinical) studies.”

Current data shows that children infected with SARS-CoV-2, the virus that causes COVID-19, tend to experience milder symptoms compared to adults. However, children who do become seriously ill from COVID-19 have a greater chance than adults of developing multisystem inflammatory syndrome or MIS-C, which causes inflammation in numerous parts of the body as a result of a dysregulated immune response. Cases of MIS-C will be one of the things that researchers will be looking out for.

If Health Canada approves any COVID-19 vaccines for children under 12 in the future, the researchers would expand their focus to include younger children as well.

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