OTTAWA — 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 ages 12 to 15, after initially authorizing it for use in individuals 16 years of age and older.
Canada is the first country in the world to sign off on giving shots to these younger age groups.
“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.
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.
“There are some provinces that have already provided some vaccine to this age group, if they were children that were at high risk. That was done off label, which is absolutely within their purview, so we do have some children in Canada that have already received a vaccine dose,” Sharma told reporters on Wednesday.
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.
Sharma said the pharmaceutical giant has indicated it could be submitting its submission to expand use to children ages five to 11 as soon as September.
Health Canada had been reviewing Pfizer-BioNTech’s submission to expand the use of the vaccine to 12 to 15 year olds 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.
As has been the case with each new COVID-19 vaccine approval from Health Canada, the agency has published a series of documents detailing its decision and a summary of the evidence reviewed.
Pfizer-BioNTech is required to continue providing Health Canada with ongoing safety and efficacy information as the product becomes used in real world settings.
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.
Sharma said that federal officials leading the national vaccine rollout will have more to say on Thursday about what this authorization might mean for the mass vaccination effort. Prior to this opening up who is able to be vaccinated, the federal government had said it’d have enough doses in Canada to fully vaccinate everyone who was eligible by the end of September.
Asked what this might mean for schools to be able to reopen, Sharma said that’ll depend on how and when provinces and territories decide to administer these shots to younger people.
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.
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