Health Canada is set to authorize the Pfizer COVID vaccine for use in children, meaning one of the biggest pediatric vaccination efforts in the country’s history will soon be underway.
With the green-lighting, expected Friday, of a smaller dose of the vaccine already in use around the world, the federal regulator is signalling that it has finished combing through data on everything from clinical trials to manufacturing plans and determined the shot is safe and effective in school-aged children.
The news means Pfizer will now begin transporting child-sized shots into the country, with vials to be fed into vaccination campaigns, the planning for which, in many jurisdictions, is already underway. Anita Anand, until recently the federal procurement minister, has previously said Canada will receive 2.9 million doses “shortly” after approval — enough to give a first dose to every eligible child.
The vaccine for children, aged five to 11, uses the same mRNA technology as the adult version, but is about one-third the size. Children will also receive two shots, but Dr. Kieran Moore, Ontario’s chief medical officer of health, told a radio station this week they will be given eight weeks apart, instead of the American recommendation of a three-week interval.
Trials suggest that even a one dose resulted in a strong immune response in children: a 91.4 per cent efficacy against infection over a period of months.
Not only will the arrival of doses be met with jubilation from many parents who want protection for their children, they’ll be an important step toward ending the pandemic for everyone.
While children are at lower risk for serious complications of COVID-19, they’re not without risk, experts say.
There is a “direct benefit” to children who get vaccinated as some of them do end up with a severe version of the illness, says Dr. Stephen Freedman, a Calgary-based pediatric emergency doctor who has led multiple studies of the impact of COVID on kids, internationally and in Canada. One Canadian study suggests that one in five kids who are admitted to hospital with COVID end up in intensive care.
There are also those who end up with problems like multi-system inflammatory syndrome, known as MIS-C, which appears to affect about one in 3,500 children who get COVID, or those who grapple with symptoms weeks or even months after being infected.
Then there are the knock-on benefits, including the fact that vaccinating children means they’re less likely to infect more vulnerable family members, and that doing so also gets all of us one step closer to some version of normal, he adds.
“Opening up society because we no longer have such a big risk? We want to get to the point,” he says. “Having people over for dinner, get-togethers, events, family reunions, all of these things are what we want. The vaccine for five-to-11-year-olds is one more step in that direction.”
While adults and teens have been rolling up their sleeves for months, the extension of the effort to kids for the first time represents a raising of the stakes for many parents who are now faced with making a vaccination decision for their child.
“As a pediatrician, I know that every parent wants what’s best for their child,” says Dr. Shazeen Suleman, who works at Unity Health Toronto. “Every decision that they’re making is coming from a place of love and caring concern. And so we know that there is a lot of information out there and that many parents have questions.”
Suleman, who is also part of the Temerty Faculty of Medicine at the University of Toronto, says she often hears from parents that the barrage of information about the vaccine has been confusing, so it will be important to make sure there is credible information available, in multiple languages. Of course, pediatricians are also happy to answer questions about vaccination, she says.
The rollout will have to make it easy for parents to bring their children in, and the government and employers should consider paid time off for appointments and sick days for caregivers who may have to stay home and care for a child dealing with side effects, she adds.
Kids are not just little adults, Suleman stresses. That means vaccination should be done in child-friendly spaces, ideally with providers that children trust, in a way that is accessible to children who have disabilities or who are neuroatypical.
Plans are already underway in many parts of the country to start getting doses into little arms as soon as possible. The city of Toronto has said it is developing a “multi-pronged strategy” to reach the city’s more than 200,000 children and their parents. Clinics will be opened in every corner of the city, and mass immunization, school and community clinics are all being considered. Family doctors and pharmacists will also be able to offer the vaccine.
Given the urgency, pharmacists have publicly wondered why they couldn’t draw up smaller doses of the vaccine instead of waiting for a child-sized version.
Dr. Jim Kellner, a professor of pediatrics at the University of Calgary who also sits on the federal COVID-19 immunity task force, says he doesn’t know exactly what Pfizer’s reasoning is, but says dividing up adult doses into smaller amounts would be “error prone.”
The adult doses are already small — about 0.3 ml, or less than one-tenth of a teaspoon — which means dividing that even further while ensuring accuracy would be challenging, he says. There isn’t enough room in the vials to dilute it and increase the amount to make it easier to handle either, he adds.
In an email, a spokesperson for Pfizer said the vials of child vaccine will contain 10 doses — to the adult vial’s six — and will have a different label and coloured cap.
Pfizer tested the child vaccine on more than 2,000 volunteers in the U.S., Finland, Poland and Spain. While the trials weren’t as large as the adult versions, they were big enough to establish that the vaccine seemed to produce the same immune response in kids as it did in those just slightly older, which is a standard way of testing vaccines that are being offered to a new group, Kellner says.
Speaking before the authorization decision, experts said one thing they’ll be looking for from Health Canada is more information on side effects.
Occasional cases of myocarditis, or inflammation of the heart muscle, have raised some concerns — in September, the British regulator said it was not recommending vaccination of healthy 12-to-15-year-olds for that reason. However, most countries, including Canada, have chosen to roll out vaccines to teens more broadly, and Canadian experts stress the risk to younger children is very, very rare.
At worst, the risk of myocarditis could be as high as one in 10,000 but is probably more like one in 50,000 or less, Kellner says. The people who have gotten it have generally had a mild case with no lingering consequences, he says.
Given how rare the complication is, the trials were likely not big enough to clarify just how frequently it occurs, he says. It’s a legitimate concern, and it’s important that vaccine side effects continue to be monitored closely.
“I can’t say to a parent that your child is absolutely zero risk,” he says. “But what I can say to them, honestly and straightforwardly and looking them in the eyes, is that the risk of an adverse event like myocarditis is very, very rare.”
Much of the pandemic has been about learning to evaluate risk and benefit, and he says in this case it makes sense to vaccinate children.
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2021-11-18 20:03:45Z
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