Health Canada approves 1st COVID-19 vaccine for youngest kids

Health Canada has approved Moderna's COVID-19 vaccine for infants and preschoolers, making it the first vaccine of its kind approved for that age group in the country.

The vaccine will be available for children between 6 months and 5 years old

A young boy gets a vaccine.
A four-year-old child receives a dose of the Moderna COVID-19 vaccine in New York on June 21. (Mary Altaffer/The Associated Press)

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.

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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

1 year ago
Duration 1:51
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."

A vial of Moderna vaccine and some cotton balls.
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

1 year ago
Duration 6:17
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.

With files from The Canadian Press