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Moderna seeking Canada authorization for the use of its Spikevax COVID-19 vaccine in children 6 to 11 years of age


Thursday, November 18, 2021 8:00:00 AM

Health Canada received a submission from Moderna seeking authorization for the use of its Spikevax COVID-19 vaccine in children 6 to 11 years of age. 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 will only authorize the use of Spikevax in children if its independent and thorough scientific review of the data in the submission shows that the benefits of the vaccine outweigh the risks in 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.

This is the second submission Health Canada has received for the use of a COVID-19 vaccine in this younger age group. On October 18, 2021, Health Canada received a submission for the use of the Pfizer-BioNTech Comirnaty vaccine in children aged 5 to 11 years of age. The submission is currently under review.

Health Canada continues to closely monitor all safety and effectiveness data from real-world use of COVID-19 vaccines since their deployment in Canada and internationally. This includes data on the use of the Pfizer-BioNTech Comirnaty vaccine in children 5 to 11 years of age where it has already been authorized for use. If any new issues are identified with any of the COVID-19 vaccines authorized for use in Canada, the Department will take action as required.

Studies with the Moderna Spikevax vaccine are ongoing in children less than 6 years of age, and other manufacturers are also testing their vaccines in children of various age ranges. Health Canada expects to receive data for different age groups for review in the coming months.

SOURCE: Health Canada