Health Canada is poised to license the Pfizer COVID vaccine for use in children, which means that one of the largest pediatric vaccination efforts in the country’s history will soon be launched.
With the green light, scheduled for Friday, for a smaller dose of the vaccine already in use around the world, the federal regulator is signaling that it has finished reviewing data on everything from clinical trials to manufacturing plans. , and has determined that the injection is safe and effective in school-age children.
The news means that Pfizer will now begin shipping child-size injections into the country, with vials to be used in vaccination campaigns, the planning of which, in many jurisdictions, is already underway. Anita Anand, until recently the federal procurement minister, has previously said that Canada will receive 2.9 million doses “shortly” after approval, enough to give a first dose to all eligible children.
The vaccine for children, ages five to 11, uses the same mRNA technology as the adult version, but is about one-third the size. The children will also receive two injections, but Dr. Kieran Moore, Ontario’s medical director of health, told a radio station this week that they will receive eight weeks apart, rather than the US recommendation of a three-week interval.
Trials suggest that even one dose resulted in a strong immune response in children – 91.4 percent efficacy against infection over a period of months.
The arrival of the doses will not only be greeted with joy by many parents who want protection for their children, but it will be an important step to end the pandemic for all.
While children are at lower risk for serious complications from COVID-19, they are not without risk, experts say.
There is a “direct benefit” to children who get vaccinated, as some of them end up with a severe version of the disease, says Dr. Stephen Freedman, a Calgary-based pediatric emergency physician who has conducted multiple studies on the impact. of COVID in children, internationally and in Canada. A Canadian study suggests that one in five children admitted to hospital with COVID end up in intensive care.
There are also those who end up with problems like multisystem inflammatory syndrome, known as MIS-C, which appears to affect about one in 3,500 children who contract COVID, or those who battle 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 the most vulnerable family members, and that doing so also brings us one step closer to some version of normal, he adds.
“Open society because we no longer run such a great risk? We want to get to the point, ”he says. “Having people for dinner, meetings, events, family gatherings, all of these things are what we want. The vaccine for children ages five to 11 is another step in that direction. ”
While adults and teens have been rolling up their sleeves for months, extending the effort to children for the first time represents an upswing for many parents now faced with making a decision about vaccinating their children.
“As a pediatrician, I know that all parents want the best for their children,” says Dr. Shazeen Suleman, who works at Unity Health Toronto. Every decision they make comes from a place of love and concern. And so we know that there is a lot of information available and that many parents have questions. “
Suleman, who is also part of the University of Toronto Temerty School of Medicine, says he often hears from parents that the barrage of information about the vaccine has been confusing, so it will be important to make sure credible information is available. . in multiple languages. Of course, pediatricians are happy to answer questions about vaccination, too, he says.
The implementation will have to make it easier for parents to bring their children, 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 suffering from side effects. , said. adds.
Children are not just small 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 are neuroatypical.
Plans are already underway in many parts of the country to begin dosing in small arms as soon as possible. The city of Toronto has said it is developing a “multi-strategy” to reach the city’s more than 200,000 children and their parents. Clinics will open in every corner of the city and mass immunizations, school and community clinics are 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 make smaller doses of the vaccine instead of waiting for a children’s version.
Dr. Jim Kellner, a professor of pediatrics at the University of Calgary who is also part of the federal COVID-19 immunity task force, says he doesn’t know exactly what Pfizer’s reasoning is, but says dividing adult doses into smaller amounts would be “ prone to errors. ”
Adult dosages are already small, around 0.3 ml, or less than a tenth of a teaspoon, which means dividing that even further and ensuring accuracy would be a challenge, he says. There is not enough room in the vials to dilute it and increase the amount to make it easier to handle, he adds.
In an email, a Pfizer spokesperson said vials of the infant vaccine will contain 10 doses, at six o’clock on the adult vial, and will have a different colored label and cap.
Pfizer tested the childhood vaccine on more than 2,000 volunteers in the US, Finland, Poland and Spain. While the trials were not as large as the adult versions, they were large enough to establish that the vaccine appeared to elicit the same immune response in children as it did in slightly older children, which is a standard way of testing vaccines that they’re offered to a new group, Kellner says.
Speaking ahead of the licensing decision, experts said one thing they will 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 did not recommend vaccinating healthy 12-15 year olds for that reason. However, most countries, including Canada, have chosen to implement adolescent vaccines more broadly, and Canadian experts emphasize that the risk to younger children is very, very rare.
In the worst case, the risk of myocarditis could be as high as one in 10,000, but it’s probably more than one in 50,000 or less, Kellner says. People who have contracted it have generally had a mild case with no lingering consequences, he says.
Given the rarity of the complication, the trials likely weren’t large enough to clarify how often it occurs, he says. It is a legitimate concern and it is important that vaccine side effects continue to be closely monitored.
“I can’t tell a parent that their child has absolutely zero risk,” he says. “But what I can tell you, honestly and directly and looking into your eyes, is that the risk of an adverse event like myocarditis is very, very rare.”
Much of the pandemic has been learning to weigh risks and benefits, and he says it makes sense in this case to vaccinate children.
Reference-www.thestar.com