Health Canada has received Moderna’s submission for authorization of its “Spikevax” COVID-19 vaccine for children aged six to 11.
According to the federal agency, the submission came Tuesday and the review is being prioritized, alongside the ongoing review of the Pfizer vaccine for children ages five to 11.
“As with all COVID-19 vaccines, the Department will prioritize the review of this submission, while maintaining its high scientific standards for safety, efficacy and quality,” Health Canada said in a statement.
Health Canada says it would only authorize the use of the pediatric vaccine if its review of the data shows that the benefits outweigh the risks to this age group.
“The assessment will include a detailed review of clinical trial results, as well as other evolving data and information about the health impacts of COVID-19 and variants of concern on children in Canada,” the agency said.
In a statement marking their submission to the European Medicines Agency for the two-dose series of their pediatric vaccine last week, Moderna said that data from its “KidCOVE” study indicates the vaccine is effective in helping prevent COVID-19 infections in children.
The review of the Pfizer-BioNTech “Comirnaty” vaccine for children has been underway since mid-October, with Canada's chief medical adviser Dr. Supriya Sharma telling reporters last Friday that the Pfizer shot could be given the regulatory green light in “one to two weeks.”
While concerns have been raised about the rare risk of myocarditis and pericarditis associated with the mRNA vaccines, according to division head of infectious diseases at SickKids Dr. Upton Allen, the rates of the occurrence of inflammation of the heart muscle or tissue surrounding the heart post-vaccination were seen at a higher rate in people aged 18 to 24 than in the 12 to 17 age group.
“It is believed and expected that the rate of myocarditis is going to be even lower in the pre-pubertal kids 11 and younger,” Allen told CTVNews.ca during a Facebook Live discussion on Monday night.
“That’s really important and reassuring, to be honest with you, as we move into this next phase of vaccination,” he said.
Echoing this during the discussion, Dr. Tali Bogler, family physician and chair of family medicine obstetrics at St. Michael's Hospital in Toronto said that myocarditis is “much more common if you were to get infected from COVID-19.”
Studies are ongoing into the safety and efficacy of the Moderna vaccine in children under the age of six, and Health Canada says it expects to receive and review new data for different age groups “in the coming months.”
With the imminent prospect of COVID-19 vaccines being authorized for this age group, plans are underway across the country to prepare for the administration of these doses.
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