Pfizer Canada and BioNTech SE today announced that Health Canada has authorized COMIRNATY, the companies’ COVID-19 vaccine for children 5 to under 12 years of age . For this age group, the vaccine is to be administered in a two-dose regimen of 10-μg 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.
“We are very proud to share this news with Canadians today. This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Fabien Paquette, Vaccines Lead, Pfizer Canada. “With this Health Canada authorization, we have achieved another key milestone in our ongoing effort to help protect families and communities, and to get this disease under control.”
“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 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.”
Health Canada based its decision on data from a Phase 2/3 randomized, controlled trial that included ~4600 children 5 to under 12 years of age (2,268 from the original group and 2,379 from the supplemental safety group).
Shipping of 10-μg pediatric doses to Canadian immunization sites in partnership with the Public Health Agency of Canada will begin imminently (ages referred to as 5y to <12y on the vial and 5 years to <12 years on the carton).
COMIRNATY (also referred to as Pfizer-BioNTech COVID-19 Vaccine), which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in Canada, the United States, the European Union, and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned or ongoing.