Health Canada announced that Moderna has already submitted its request for authorization regarding the administration of its COVID-19 vaccine, Spikevax, to kids aged six to eleven years old.
The Massachusetts-based biotechnology company’s request for approval came a month after Pfizer submitted its authorization request for its pediatric vaccine on October 18. Notably, Pfizer has already obtained authorization from Health Canada.
The country’s health regulator stressed that they 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 health agency also pointed out that 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.”
Moreover, Health Canada stressed that it 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 monitoring includes data on the utilization of the “Pfizer-BioNTech Comirnaty vaccine in children 5 to 11 years of age where it has already been authorized for use.”