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

Nearly two million of Canada's youngest children will soon be eligible for immunization againstCOVID-19 now that the federal drug regulator has approvedModerna'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'sproduct 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 sixmonths 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 vaccineand 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 itwill continue to monitor the vaccine's safety and effectiveness following approval

Health Canada approves Moderna vaccine for children 6 months to 5 years

2 years ago

Duration 1:50

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 Modernavaccine 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 withCOVID-19 wouldbenefit 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."

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. Itsays 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 includedmild 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 duringthe trials.

Dr. Tehseen Ladha, an Edmonton-based pediatrician, saidthe evidence in favour ofvaccination 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," LadhatoldCBC 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, NACIdocuments said.

The United States approved the Moderna and Pfizerpediatric COVID-19 vaccines last monthand hasimmunized 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 Canadais 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 coronaviruspassed on through their mothers.