Health Canada has approved the use of Pfizer-BioNTech’s COVID-19 Comirnaty vaccine for youngsters aged five to 11 years. The authorization was reported in a formal news release from Pfizer on Friday. Comirnaty is the vaccine brand name given by Pfizer-BioNTech.
With this authorization, Comirnaty is currently the only COVID-19 vaccine available in Canada for use in this age group. Pfizer said this represents an important milestone with the potential to help protect school-aged children from COVID-19 infection.
The company said the vaccine is to be administered in a two-dose regimen of 10-μg (micrograms) doses given three weeks apart.
"The 10-μg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in Canada for individuals 5 to under 12 years of age," said the company.
The release said Health Canada based its decision on data from a Phase 2/3 randomized, controlled trial that included ~4600 children five to under 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group).
"Today's authorization is supported by clinical data showing a positive benefit risk profile and high vaccine efficacy in children, underlining its potential to address a current public health need," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
"As children 5 to 12 years are approaching the end of the year, both in and out of the classroom, our goal is to offer a vaccine to help keep them safe and protected. We will continue to work towards broadening the access to our vaccine, also for younger age groups."
