OTTAWA — Health Canada has received Moderna’s submission for authorization of its “Spikevax” COVID-19 vaccine for children ages 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.
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.”
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 prospect of COVID-19 vaccines being authorized for this age group imminently, plans are underway across the country to prepare for the administration of these doses.
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