Nearly two million of Canada’s youngest children will soon be eligible for immunization against COVID-19 now that the federal drug regulator has approved Moderna’s COVID-19 vaccine for infants and preschoolers.
Health Canada now says the Moderna vaccine can be given to young children between the ages of six months and five years in doses one-quarter the size of those approved for adults.
Moderna’s product is the first COVID-19 vaccine approved for children under five in Canada.
“After a thorough and independent scientific review of the evidence, the department has determined that the vaccine is safe and effective at preventing COVID-19 in children between six months and five years of age,” the Public Health Agency of Canada announced on Twitter Thursday.
The agency said it will continue to keep a close eye on the safety of the vaccine and has required Moderna to provide updated data on the safety and effectiveness of the vaccine.
In the decision posted on the Health Canada website, the agency said Phase 3 trial results for the drug show the immune response in children aged six months to five years was comparable to Moderna’s vaccine for 18- to 25-year-olds.
WATCH | Health Canada say it will continue to monitor the vaccine’s safety and effectiveness following approval
Health Canada approves Moderna vaccine for children 6 months to 5 years
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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.
Trials studying the vaccine’s effectiveness in young children were conducted this past winter when the Omicron variant became dominant.
Preliminary data showed the Moderna vaccine prevented symptomatic COVID-19 at a rate of 50.6 per cent in children between 6 and 23 months old, and at a rate of 36.8 per cent in children 2 to 5 years old.
About 1.7 million kids now eligible for vaccination
The approval expands COVID-19 vaccine eligibility to approximately 1.7 million children in Canada. The provinces will decide where and when the vaccine will be given to kids.
Dr. Howard Njoo, Canada’s deputy chief public health officer, said that even children already infected with COVID-19 would benefit from the vaccine’s added protection.
“COVID-19 vaccination in younger children will increase their protection against severe illness,” Njoo told a news conference. “Even if a child has been previously infected with COVID-19, vaccination is still important.”
Vaccines administered to children between six months and five years old will be about about a quarter of the size of adult doses. (Garrett Barry/CBC)
Health officials said that children who have tested positive for COVID-19 or display symptoms should wait eight weeks before starting the series of vaccinations.
The authorized interval for the two vaccine doses is four weeks, although NACI recommends a period of eight weeks between shots. It says the longer period can result in a more robust and durable immune response.
No safety concerns detected
Health Canada said there were no safety concerns identified in the study. The most common reactions were similar to the ones kids experience with other pediatric vaccines, such as pain at the injection site, sleepiness and loss of appetite.
Less common reactions included mild to moderate fever, swelling at the injection site, nausea, tender lymph nodes under the arm, headaches and muscle aches.
The advisory body noted that adverse side effects occurring at a rate of less than 6 per 100,000 likely would not have been detected during the trial.
Health Canada said there are still some uncertainties about the vaccine because it’s new and researchers don’t have long-term data yet. For example, there’s little information about the risk of very rare reactions like myocarditis — a swelling of heart tissue — although no such cases came up during the trials.
Dr. Tehseen Ladha, an Edmonton-based pediatrician, said the evidence in favour of vaccination remains overwhelming.
WATCH | Pediatrician offers vaccination advice to parents of young children
Newly approved COVID-19 vaccine for children ‘a beacon of light,’ pediatrician says
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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.
“If we’re going to weigh the risks and benefits, we’re looking at whether to give a vaccine that’s been rigorously studied … versus Covid infection, where we don’t know the long-term effects and we do know for certain that it can cause severe consequences,” Ladha told CBC News Network.
To the parents of young children, Ladha said: “I would certainly recommend going for the vaccine rather than exposing them to infection.”
There is also more to learn about the safety and effectiveness of the vaccine in young children with other health conditions or who are immunocompromised, NACI documents said.
The United States approved the Moderna and Pfizer pediatric COVID-19 vaccines last month and has immunized 267,000 children in that age group as of July 8.
Pfizer’s pediatric COVID-19 vaccine for young children between six months and five years old was submitted to Health Canada last month and is still under review.
Dr. Marc Berthiaume of the Health Canada Bureau of Medical Sciences said Canada is not aware of any ongoing studies examining the use of COVID-19 vaccines for children under six months old. He said infants of that age may benefit from antibodies against the coronavirus passed on through their mothers.
Demands for government intervention in Air Canada labour talks could negatively affect airline competition in Canada, the CEO of travel company Transat AT Inc. said.
“The extension of such an extraordinary intervention to Air Canada would be an undeniable competitive advantage to the detriment of other Canadian airlines,” Annick Guérard told analysts on an earnings conference call on Thursday.
“The time and urgency is now. It is time to restore healthy competition in Canada,” she added.
Air Canada has asked the federal government to be ready to intervene and request arbitration as early as this weekend to avoid disruptions.
Comments on the potential Air Canada pilot strike or lock out came as Transat reported third-quarter financial results.
Guérard recalled Transat’s labour negotiations with its flight attendants earlier this year, which the company said it handled without asking for government intervention.
The airline’s 2,100 flight attendants voted 99 per cent in favour of a strike mandate and twice rejected tentative deals before approving a new collective agreement in late February.
As the collective agreement for Air Transat pilots ends in June next year, Guérard anticipates similar pressure to increase overall wages as seen in Air Canada’s negotiations, but reckons it will come out “as a win, win, win deal.”
“The pilots are preparing on their side, we are preparing on our side and we’re confident that we’re going to come up with a reasonable deal,” she told analysts when asked about the upcoming negotiations.
The parent company of Air Transat reported it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31. The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.
Revenue totalled $736.2 million, down from $746.3 million in the same quarter last year.
On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.
It attributed reduced revenues to lower airline unit revenues, competition, industry-wide overcapacity and economic uncertainty.
Air Transat is also among the airlines facing challenges related to the recall of Pratt & Whitney turbofan jet engines for inspection and repair.
The recall has so far grounded six aircraft, Guérard said on the call.
“We have agreed to financial compensation for grounded aircraft during the 2023-2024 period,” she said. “Alongside this financial compensation, Pratt & Whitney will provide us with two additional spare engines, which we intend to monetize through a sell and lease back transaction.”
Looking ahead, the CEO said she expects consumer demand to remain somewhat uncertain amid high interest rates.
“We are currently seeing ongoing pricing pressure extending into the winter season,” she added. Air Transat is not planning on adding additional aircraft next year but anticipates stability.
“(2025) for us will be much more stable than 2024 in terms of fleet movements and operation, and this will definitely have a positive effect on cost and customer satisfaction as well,” the CEO told analysts.
“We are more and more moving away from all the disruption that we had to go through early in 2024,” she added.
This report by The Canadian Press was first published Sept. 12, 2024.
