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 six months and five years old, in doses one-quarter the size of that approved for adults.
The approval was based on review of clinical trial data from Canada and the United States, and means 1.7 million more Canadians will soon be able to get a vaccine against the COVID-19 virus.
Many parents have been waiting for this announcement, and many also have questions.
CBC News talked with health experts to get answers.
What’s the benefit for younger kids?
While the vast majority of young children who catch COVID-19 show only mild symptoms, some can develop more serious cases of the illness and require hospitalization.
Hospitalizations among children under five rose considerably after the arrival of the Omicron variant in December.
According to the Public Health Agency of Canada, that rate climbed from 1.4 per 100,000 children between March 1, 2020, and Dec. 31, 2021, to 15.9 per 100,000 between Jan. 1, 2022, and March 31, 2022.
The vaccine gives parents an option that will help reduce that risk and provide strong protection against serious illness, said Dr. Katharine Smart, a pediatrician and the president of the Canadian Medical Association.
“Right now, one of the most common risks to children in terms of an infectious disease is COVID-19,” she said.
The clinical trial data, gathered after the arrival of Omicron, showed the Moderna vaccine prevented symptomatic COVID-19 at a rate of 50 per cent in children between six and 23 months of age, and at a rate of 37 per cent in children two to five years old.
It’s not yet clear from the existing data whether the vaccine will help curb transmission, said Smart — although research on other age groups has demonstrated vaccines help in this regard. “We don’t really have the data to answer it,” she said.
What are the side effects of the vaccine?
The clinical trial data found fatigue to be the main side effect, along with irritability, crying, and pain at the injection site.
Reactions were mild to moderate and disappeared a few days after the vaccination.
No cases of myocarditis — a swelling of heart tissue that had been seen in rare instances among older age groups after getting vaccinated — came up in the trials. In individuals 16 and older, the risk of myocarditis was actually higher from COVID-19.
Health Canada adviser Dr. Supriya Sharma says the agency will continue to receive data from Moderna regarding its safety and effectiveness following its approval for use in younger children.
Health Canada said there are still some uncertainties about the vaccine because it’s new and there’s 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, those symptoms kind of just demonstrate that the vaccine is actually working in the child’s body. And within a day or two, any of those side effects are gone and it’s back to the business of being children.”
If my child just had COVID, should I wait to get them vaccinated?
Children who have tested positive for COVID-19 or display symptoms should wait eight weeks before starting the series of vaccinations, according to the National Advisory Committee on Immunization (NACI).
That’s not because of any 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 and they got vaccinated, it doesn’t mean they’re not going to respond to the vaccine.”
“We just know when we have those longer intervals that we tend to see a better and longer lasting immune response,” she said.
How far apart are the doses?
NACI is recommending 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 this is consistent with previous NACI recommendations for a longer interval between doses for older children and adults.
“What we’ve seen is those decisions have actually worked out very well in terms of the quality of their immune response that we’re getting,” she said.
It is recommended that children who are moderately to severely immunocompromised get three doses, under a shortened interval of four to eight weeks between doses.
Dr. Fatima Kakkar, an infectious diseases pediatrician and pediatrics professor at the University of Montreal, said getting those additional doses faster to more vulnerable children will give them extra protection — and give their parents peace of mind.
“There’s a group of parents that has been waiting and waiting and waiting this out. And these are the parents of children with chronic conditions,” Kakkar said.
Can my child get the COVID vaccine and other vaccines at the same time?
NACI recommended waiting 14 days between the vaccine for COVID-19 and another vaccine.
This is common practice whenever a new vaccine is introduced, said the experts spoken to by CBC News.
“If you’ve done two things at the same time, it makes it difficult if there’s a complication to know what caused it,” Smart said.
“It’s not necessarily that it’s dangerous to get them together, rather that it would be difficult to differentiate side effects if you’ve had two vaccines at the same time when this is a vaccine that we’re still learning about.”
Pediatrician Dr. Tehseen Ladha says Moderna’s newly approved COVID-19 vaccine for children under five is safer than potentially exposing children to the virus.
Should I wait for the Pfizer vaccine?
The Pfizer vaccine for children under five has still not been approved by Health Canada. It was approved last month in the United States.
Kakkar’s recommendation is for parents who want to get their children vaccinated to do it now, given the uncertain timeline.
“I think the Moderna trial data has been reviewed by NACI and has been reviewed by Health Canada, and they’re confident in its safety and security.”
Smart added that one advantage to the Moderna vaccine is most children require only two shots — which means fewer needles for squeamish little kids — while Pfizer requires 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 many families, it’s possible that you may not end up completing the series,” she said.
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 shortly,” but didn’t provide a specific timeline.
Several provinces told CBC News they expect to make the vaccine available in the coming weeks.
Health Canada has approved the first COVID-19 vaccine for kids between six months and five years old. The Moderna vaccine dose for them will be smaller than for adults, and will require two shots. Shipments to some provinces could start within days.
Jason Kindrachuk, a virologist and assistant professor in medical microbiology and infectious diseases at the University of Manitoba, said it’s difficult to know for sure what this means for the pandemic, given the evolving nature of the virus.
But, at the very least, the vaccine for young children represents “another piece of the puzzle,” he said.
While the data doesn’t yet spell it out, having younger kids vaccinated may also help reduce the risk of spreading the virus, he said.
“You’re helping with trying to reduce the overall impact on health care, while also hopefully reducing some of the symptoms that come with COVID-19 and potentially being able to reduce transmission based on that,” he said.
