/Health Canada approves giving Pfizer COVID-19 vaccine to children ages 12 and up | CTV News

Health Canada approves giving Pfizer COVID-19 vaccine to children ages 12 and up | CTV News

Health Canada says the Pfizer-BioNTech COVID-19 vaccine is now safe to give to children ages 12 and up.

The federal health agency has announced it has approved administering the vaccine to children 12 to 15, after initially authorizing it for use in individuals 16 years of age and older.

“After completing a thorough and independent scientific review of the evidence, the department determined that this vaccine is safe and effective when used in this younger age group,” said Health Canada’s chief medical adviser Dr. Supriya Sharma.

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Health Canada has authorized those 12 years of age and older to be given the same dose regimen as adults. The authorization was based on the results of Pfizer-BioNTech’s Phase 3 clinical trial involving 2,260 adolescents aged 12 to 15.

Conducted in the United States, the trial found the vaccine to be 100 per cent effective in children aged 12 to 15, up from the 95 per cent efficacy shown after the second shot in the trials with older age groups.

“While younger people are less likely to experience serious cases of COVID-19, having access to a safe and effective vaccine will help control the disease’s spread to their family and friends, some of whom may be at higher risk of complications. It will also support the return to a more normal life for our children who have had such a hard time over the past year,” Sharma said.

The two-dose Pfizer vaccine was the first COVID-19 vaccine to be authorized by Health Canada. It was given the regulatory green light in December 2020 and was the first COVID-19 vaccine to be administered in this country. 

In a statement about being the first COVID-19 vaccine Canada has authorized for use in younger age groups, Pfizer Canada’s vaccine lead Fabien Paquette called it “a significant step forward in helping the Canadian government broaden its vaccination program and begin to help protect adolescents before the start of the next school year.”

BioNTech’s chief medical officer Ozlem Tureci said research is continuing on the use of the vaccine in pediatric populations, with a study ongoing into the safety and efficacy in children six months to 11 years of age. 

Health Canada had been reviewing Pfizer-BioNTech’s submission to expand the use of the vaccine since mid April.

“The most commonly reported side effects were temporary and mild, like a sore arm, chills or fever,” Sharma said.

Typically, the vaccine submission review process can take much longer, but because of an emergency order, Health Canada has been able to expedite the authorization process. 

The vaccine is an mRNA vaccine, which means it teaches cells how to make a protein that triggers an immune response, without using the live virus that causes COVID-19. Once that immune response is triggered, antibodies are produced, which protect people from being infected should the virus enter their system in the future.

After a winter delay as production capacity was increased, the manufacturing giant has been Canada’s most consistent supplier of vaccines. With nearly 11 million doses sent to Canada to date, Pfizer has committed to sending more than two million doses per week, each week, until end of June.

The U.S. Food and Drug Administration is also expected to authorize the vaccine for 12 to 15 year olds next week, according to The Associated Press.