Health Canada has approved the Pfizer COVID-19 vaccine for children aged five to 11, the department announced Friday.
This means elementary school children will be able to get vaccinated against COVID-19. Previously, only kids aged 12 and up were eligible.
The vaccine will require two doses of 10 micrograms each for kids aged five to 11 — one-third of the dose for adults. The National Advisory Committee on Immunization (NACI) is recommending the two doses be spaced eight weeks apart.
Canada will begin receiving shipments of the doses for young children on Sunday, Public Services and Procurement Minister Filomena Tassi announced Friday. All of the 2.9 million doses ordered will be received by the end of the week.
This is enough vaccine to provide first doses for all eligible children in the country, she said.
NACI recommends children should not receive another vaccine, such as a flu shot, 14 days before or after the Pfizer COVID-19 vaccine. This is to help medical professionals pinpoint the source of any adverse events, and determine whether they are due to the COVID-19 vaccine or something else, according to Dr. Theresa Tam, chief public health officer of Canada.
Children who have previously had COVID-19 may be offered two doses of vaccine, once their acute symptoms have resolved and they are no longer considered infectious, NACI recommends.
Eleven-year-olds should receive the smaller pediatric dose of vaccine, NACI said. But, if they turn 12 between receiving their first and second dose, the second dose can be the adult formulation. Children will be considered fully vaccinated if they receive two doses of either formulation, or one of each.
Pfizer submitted its trial data to Health Canada on Oct. 1 for evaluation, and the full submission for approval on Oct. 18.
“This is very good news for adults and children alike,” said Dr. Supriya Sharma, a senior medical advisor with Health Canada, at a press conference Friday.
“It provides another tool to protect Canadians, and to the relief of many parents, will help bring back a degree of normality to children’s lives, allowing them to more safely do the things that they have missed during the last 20 months.”
Pfizer’s clinical trial data showed that the vaccine had 91 per cent efficacy against COVID-19 in this age group.
Some of the side effects reported, according to Sharma, included redness and swelling at the injection site, headaches and fatigue. Most of the side effects were mild to moderate and resolved quickly on their own, she said.
Out of the 3,100 children vaccinated, four serious adverse events were reported, but they were later determined not to be related to the vaccine, Sharma said. There were no reports of myocarditis, pericarditis or serious allergic reactions.
“While children are less likely to experience complications, they can still get very sick,” said Sharma, noting some children can develop multi-inflammatory syndrome in children (MIS-C) or long COVID — following COVID-19 infection.
“After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks,” Health Canada wrote in a press release.
“Health Canada has placed terms and conditions requiring Pfizer-BioNTech to continue providing information to Health Canada on the safety and efficacy of the vaccine in this younger age group. This will provide the Department with more data from ongoing studies and real-world use to ensure that the benefits of the vaccine continue to outweigh any risks, as well as to detect any potential new safety signals in any age group.”
The provinces have been preparing for this announcement for weeks, with many drawing up plans for how they will distribute the vaccines. In Ontario, children will likely be vaccinated at school, though it’s unclear whether it will happen during school hours.
It’s also unclear how many parents will jump at the opportunity to vaccinate their young children. A recent survey found only half of parents intended to “immediately” vaccinate their kids when a vaccine became available.
Tam noted that vaccine uptake among adolescents 12 and up was high — with 81 per cent of that group currently fully vaccinated.
“Those adolescents we can look to as inspiration, they’ve got their vaccines, their parents are supported to get the vaccines. Now we’ve got another chance with a younger group of kids, but we’ve already had great successes,” she said.
Dr. Anna Wolak, a mother from Vancouver, spoke to Global News ahead of the announcement, knowing that it was anticipated soon. “I’m ecstatic. I’m thrilled and so relieved, because finally, I can protect my little ones a bit more than what we are already offering them now,” she said.
Some still have concerns though.
“If it’s safe, it’s a good idea,” said Gordon Riley, an Edmonton grandfather who is nervous about his grandson being vaccinated. “I have nothing against it, but they’ve tested it so fast. You have to wonder if it’s really as safe as they say.”
Around 78 per cent of the total Canadian population has received at least one dose of COVID-19 vaccine, according to data from the Public Health Agency of Canada. Adding children would significantly increase the proportion eligible to receive the shot and potentially push that number higher.
The U.S. approved Pfizer’s COVID-19 vaccine for children on Nov. 2 and began vaccinating children under 12 shortly afterward.
Health Canada is also currently reviewing an application from Moderna for approval of a COVID-19 vaccine for children aged six to 11.
—with files from Global News’ Jamie Mauracher and Reuters