Health Canada is authorizing the Pfizer-BioNTech COVID-19 vaccine for adolescents aged 12 to 15, meaning that the jab is now approved for anyone over the age of 12 in Canada.
Until now, the shot had only been approved for Canadians over the age of 16.
“This is the first vaccine authorized in Canada for the prevention of COVID-19 in children, and marks a significant milestone in Canada’s fight against the pandemic,” said Health Canada’s chief medical advisor Dr. Supriya Sharma.
Canada is the first country in the world to extend this approval to children, Sharma added.
The announcement comes after the drugmakers said their vaccine was found to be safe and effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial late last month.
The companies said more than 2,200 adolescents between 12 and 15 participated in the trial.
A total of 18 cases of the coronavirus were identified in the group that was given a placebo shot, but no infections were declared in the group that was given the COVID-19 vaccine.
Since the start of the COVID-19 pandemic, 20 per cent of cases have been among Canadians under the age of 19, according to Sharma.
“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.
“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.”
The Health Canada approval comes with some strings attached. Like all other vaccine approvals that were made under interim orders, Pfizer-BioNTech has to keep Health Canada up to date with “additional information” on the vaccine’s “safety efficacy and quality” to make sure the benefits continue to outweigh the risks.
As things stand now, Sharma said the benefits of the jab clearly outweigh the risks.
“The safety profile of the Pfizer-BioNTech vaccine in 12- to 15-year-olds is similar to what we saw for older people. That is, the most commonly reported side effects were temporary and mild, like a sore arm, chills or fever,” she said.
“We also know that millions of people have received the Pfizer vaccine, and no new safety issues have been identified.”
What about younger kids?
There are no vaccines currently approved in Canada for children under the age of 12 — but Sharma said research into the safety of COVID-19 vaccines for younger kids is underway now.
“Pfizer does have ongoing trials in younger age groups as well,” Sharma said.
“They’ve signalled that they may be giving Health Canada a submission for the younger age groups of five to 11 as soon as September.”
There are other clinical trials underway for that same age group, she added, but Health Canada doesn’t “have specific timing” on when they would receive those submissions.
“We may be getting those in the in the next few months,” Sharma said.
The timing of when these vaccines will be given to younger children, even once approved, will be based on provincial rollout decisions, according to Sharma.
“The use of those vaccines really is dependent on the provinces and territories that need to look at their own demographics, their priority groups and how they how they use the supply,” she said.
“So it really would depend on the provinces and territories about when the availability would be there for the younger age groups and then what implications that would have with respect to school opening.”
Overall, Sharma said Wednesday’s announcement is “good news.”
“We are starting to see the light at the end of the tunnel, but until the majority of Canadians are vaccinated, we need to continue to be diligent about following public health guidelines,” Sharma said.
“That means keeping our physical distance, continuing to wear a mask and washing our hands.”
— With files from Global News’ Hannah Jackson