Health Canada Approves Pfizer COVID-19 Vaccine For Children 12 Years and Older

OTTAWA – Health Canada says the Pfizer-BioNTech COVID-19 vaccine can now be safely administered to children 12 years of age and older.

The federal health agency has announced that it has approved the administration of the vaccine to children between the ages of 12 and 15, after initially clearing it for use in people 16 and older.

“After conducting a thorough and independent scientific review of the evidence, the ministry has determined that this vaccine is safe and effective when used in this younger age group,” Health Canada’s Chief Medical Advisor said, Dr. Supriya Sharma.

Health Canada has allowed people 12 years of age and older to receive the same dosing schedule as adults. The authorization was based on the results of the Phase 3 clinical trial of Pfizer-BioNTech involving 2,260 adolescents aged 12 to 15 years.

Conducted in the United States, the trial concluded that vaccine 100% effective in children aged 12 to 15 years, compared to an efficacy of 95% indicated after the second injection in trials with older groups.

“While younger people are less likely to suffer from severe cases of COVID-19, having access to a safe and effective vaccine will help control the spread of the disease to their family and friends, some of whom may be at greater risk. high of complications. It will also support the return to a more normal life for our children who have been through difficult times over the past year, ”said Sharma.

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

“Some provinces have already provided vaccines to this age group, if they were high risk children. It was done off-label, which is absolutely their responsibility, so we have children in Canada who have already received a dose of the vaccine, ”Sharma told reporters on Wednesday.

Although federal officials said on Wednesday that Canada was the first country in the world to allow the Pfizer-BioNTech vaccine for children 12 and older, a Pfizer spokesperson later said Algeria had it. did last month.


In a statement on the first COVID-19 vaccine Canada cleared for use in younger age groups, Fabien Paquette, vaccine manager at Pfizer Canada, called “important step forward to help Canadian government expand program vaccination program and start protecting adolescents before the start of the next school year. “

BioNTech chief medical officer Ozlem Tureci said research continues on the use of the vaccine in pediatric populations, with a safety and efficacy study underway in children six months to 11 years of age. .

Sharma said the pharmaceutical giant has indicated it could submit its submission to expand use to children aged five to 11 as early as September.

Health Canada reviewed Pfizer-BioNTech’s submission to extend vaccine use to children aged 12 to 15 since mid-April.

“The most commonly reported side effects were temporary and mild, such as arm pain, chills or fever,” Sharma said.

Typically, the vaccine submission review process can take significantly longer, but due to an emergency order, Health Canada was able to expedite the authorization process.

Other licensed COVID-19 vaccine manufacturers are also conducting trials with their vaccines in children and it is likely that over time, other vaccines used in Canada may begin to be made available to young people.

As has been the case with every new COVID-19 vaccine approval by Health Canada, the agency has released a series of documents detailing its decision and a summary of the evidence reviewed.

Pfizer-BioNTech is required to continue to provide ongoing safety and efficacy information to Health Canada as the product is used in real 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 this immune response is triggered, antibodies are produced which protect people from infection if the virus enters their system in the future.

“Anyone who has agreed to be vaccinated themselves should be prepared to have their children vaccinated as well. They’re doing the right thing, ”said pediatrician and infectious disease specialist Dr. Jim Kellner in an interview with CTV News Channel, adding that seeing children get vaccinated will be key to Canada achieving immunity. collective against COVID-19.

When asked what it might mean for schools to be able to reopen, Sharma said it will depend on how and when provinces and territories decide to give these vaccines to young people.


Sharma said federal officials leading the nationwide vaccine rollout will have more to say on Thursday about what the clearance might mean for the mass vaccination effort.

Before expanding the number of people who could become eligible for vaccination, the federal government said it would have enough doses in Canada to fully immunize all eligible people by the end of September.

Shortly after Health Canada’s announcement, Alberta announced that all Albertans aged 12 and over will be eligible and will be able to register to receive this vaccine starting Monday. Ontario said on Wednesday that plans are being made to start vaccinating Ontarians between the ages of 12 and 18, but there is no specific timeline on when they can still reserve their vaccines.

In an interview on CTV News Channel, emergency room doctor Dr. Lisa Salamon suggested that in hot spots across the country, injections should begin to be available to children 12 and older.

“It’s going to be complicated… But they are the spreaders,” she said, suggesting that when parents come to get vaccinated, eligible family members should be able to accompany them.

“We have enough vaccines. I think we really need to seriously consider – especially in hot spots when we have structural barriers here – to be able to bring in the younger members of those families and so that they can reunite as families and get everyone vaccinated. as soon as possible who are eligible, ”she said.

After a winter delay due to increased production capacity, the manufacturing giant has been the most consistent vaccine supplier in Canada. With nearly 11 million doses shipped to Canada to date, Pfizer has committed to ship more than two million doses per week, every week, until the end of June.

Citing the increase in the number of vaccines arriving each week, Johanu Botha, co-director of the Manitoba Vaccine Implementation Task Force, said on Wednesday the province is aiming to have all Manitobans aged 12 and over eligible. by May 21.

The U.S. Food and Drug Administration is also expected to approve the vaccine for children ages 12 to 15 next week, according to the Associated Press.

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