Health Canada authorizes Pfizer vaccine for children 12 and up

On Wednesday, Health Canada authorized the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age. 

This is the first COVID-19 vaccine authorized in Canada for use in children.

Dr. Supriya Sharma, the chief medical adviser at Health Canada, called it “a significant milestone in Canada’s fight against the pandemic,” that could allow young people to safely return to school and extracurricular activities.

Canada is the first country in the world to extend this approval to children, Dr. Sharma added.

Health Canada received an application to expand the indication of Pfizer-BioNTech’s COVID-19 vaccine on April 16, 2021. The vaccine was initially authorized for use in people 16 years of age and older on December 9, 2020.

“After completing a thorough and independent scientific review of the evidence, the Department has determined that this vaccine is safe and effective at preventing COVID-19 when used in children between 12 and 15 years of age,” a statement from the regulatory body said.

However, Health Canada has placed terms and conditions on this authorization. Pfizer-BioNTech must continue providing information to Health Canada on the safety, efficacy and quality of the vaccine in this younger age group to ensure its benefits continue to be demonstrated once it is on the market.

Both Health Canada and the Public Health Agency of Canada will also continue to closely monitor the safety of this vaccine and will take action if any safety concerns are identified.

According to Dr. Sharma since the start of the COVID-19 pandemic, 20 per cent of cases have been among Canadians under the age of 19.

“While younger people are less likely to experience serious cases of COVID-19, having access to a safe and effective vaccine will help to control the disease’s spread to their families and friends — some of whom may be at a higher risk of complications,” Sharma said.

There are no vaccines currently approved in Canada for children under the age of 12. But research into the safety of COVID-19 vaccines for younger kids is underway now, Dr. Sharma added.




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