Canada’s drug regulator, for the first time, has approved a COVID-19 vaccine for infants and preschoolers.
Health Canada announced on Thursday that the Moderna vaccine can be given to young children between the ages of six months and five years, at doses that are a quarter of those approved for adults.
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The approval was based on review of clinical trial data from Canada and the United States, and means that 1.7 million more Canadians will soon be able to get vaccinated against the COVID-19 virus.
Many parents have been waiting for this announcement, and many have questions as well.
CBC News spoke to health experts for answers.
What is the benefit for young children?
While the vast majority of young children who catch COVID-19 have only mild symptoms, some may develop more severe cases of the disease and requires hospitalization.
Hospitalizations among children under five increased dramatically after the arrival of the Omicron variant in December.
According to the Public Health Agency of Canada, this rate increased from 1.4 per 100,000 children between March 1, 2020 and December 31, 2021 to 15.9 per 100,000 between January 1, 2022 and March 31, 2022 .
The vaccine offers parents an option that will help reduce that risk and provide strong protection against serious illness, said Dr. Katharine Smart, pediatrician and president of the Canadian Medical Association.
“Right now, one of the most common infectious disease risks to children is COVID-19,” she said.
Clinical trial data, collected after Omicron’s arrival, showed that the Moderna vaccine prevented symptomatic COVID-19 at a 50% rate in children aged six to 23 months, and at a 37% rate. in children two to five years old.
From existing data, it’s not yet clear whether the vaccine will help curb transmission, Smart said – although research in other age groups has shown that vaccines help in this regard. “We don’t really have the data to answer that,” she said.
What are the side effects of the vaccine?
Data from clinical trials revealed that fatigue was the main side effect, along with irritability, crying and pain at the injection site.
The reactions were mild to moderate and disappeared a few days after vaccination.
No cases of myocarditis – swelling of the heart tissue that had been observed in rare cases among older age groups after being vaccinated – appeared in trials. In people 16 and older, the risk of myocarditis was actually higher because of COVID-19.
Health Canada said there are still uncertainties about the vaccine because it is new and there are no long-term data available yet.
But overall, said Toronto pediatrician Dr. Dan Flanders, the trial demonstrates a “very, very safe profile.”
“In a way, these symptoms kind of demonstrate that the vaccine is actually working in the child’s body. And within a day or two, all those side effects are gone and it’s back to business to be children.”
If my child has just had COVID, should I wait to get him vaccinated?
Children who have tested positive for COVID-19 or are showing symptoms should wait eight weeks before starting the series of vaccinations, according to the National Advisory Committee on Immunization (NACI).
It’s not because of a risk of complications, but because waiting longer will help optimize the immune response, Smart said. “If your child had COVID and you didn’t know about it and they got vaccinated, that doesn’t mean they won’t respond to the vaccine.”
“We just know that when we have these longer intervals, we tend to see a better and longer lasting immune response,” she said.
What is the distance between the doses?
NACI recommends a dosing interval of at least eight weeks between the first and second dose, which is longer than the four weeks between doses during the Moderna trial.
Smart pointed out that this is consistent with previous NACI recommendations for a longer interval between doses for older children and adults.
“What we’ve seen is that those decisions have actually worked really well in terms of the quality of their immune response that we’re getting,” she said.
It is recommended that moderately to severely immunocompromised children receive three doses, with a shortened interval of four to eight weeks between doses.
Dr. Fatima Kakkar, a pediatrician specializing in infectious diseases and a professor of pediatrics at the University of Montreal, said getting these extra doses to the most vulnerable children sooner will give them extra protection and reassure their parents.
“There’s a group of parents who wait and wait and wait. And those are the parents of children with chronic illnesses,” Kakkar said.
Can my child receive the COVID vaccine and other vaccines at the same time?
NACI has recommended waiting 14 days between the COVID-19 vaccine and another vaccine.
This is standard practice whenever a new vaccine is introduced, said experts interviewed by CBC News.
“If you did two things at the same time, it’s hard, if there’s a complication, to know what caused it,” Smart said.
“It is not necessarily that it is dangerous to put them together, but rather that it would be difficult to differentiate the side effects if you received two vaccines at the same time when it is a vaccine on which we are still learning.”
Should I wait for the Pfizer vaccine?
The Pfizer vaccine for children under five has yet to be approved by Health Canada. It was approved last month in the United States.
Kakkar’s recommendation is that parents who wish to have their children vaccinated do so now, given the uncertain timeline.
“I think the data from the Moderna trial has been reviewed by NACI and by Health Canada, and they are confident in its safety and security.”
Smart added that one of the advantages of the Moderna vaccine is that most children only need two injections – which means fewer needles for small, delicate children – while Pfizer needs three.
“With Pfizer, you have to have three shots and you really don’t see any significant immune response until that third shot. And I think for a lot of families, you may not finish the series,” she said. declared.
When will it be available and what does this mean for the pandemic?
Howard Njoo, Canada’s deputy chief public health officer, said the vaccine would be distributed to provinces and territories “very soon”, but did not provide a specific timeline.
Several provinces told CBC News they plan to make the vaccine available in the coming weeks.
Jason Kindrachuk, a virologist and assistant professor of medical microbiology and infectious diseases at the University of Manitoba, said it’s hard to know for sure what this means for the pandemic, given the evolutionary nature of the virus.
But, at the very least, the vaccine for young children represents “another piece of the puzzle,” he said.
Although the data does not yet specify, vaccinating young children can also help reduce the risk of spreading the virus, he said.
“You are helping to try to reduce the overall impact on health care, while hopefully reducing some of the symptoms that come with COVID-19 and potentially being able to reduce transmission based on that,” did he declare.