Pfizer BioNTech requests Approval of Vaccine for 5 to 11 Year Olds

This marks the first request for approval for this age group for a Covid-19 vaccine


Health Canada announced today that they have received a request from Pfizer BioNTech seeking authorization for the use of their Covid-19 vaccine in children 5 to 11 years of age.

Health Canada says they will prioritize the review of the submission while maintaining its high scientific standards for safety, efficacy and quality.

They say this is the first submission they have received for the use of a Covid-19 vaccine in this younger age group.

They add they will only authorize the use of Comirnaty (trade name of the vaccine) if the independent and thorough scientific review of all data shows that the benefits of the vaccine outweigh the potential 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.