Health Canada Approves COVID-19 Vaccine for Children

COVID-19. Health Canada authorizes the administration of the COVID-19, COMIRNATY, vaccine from Pfizer Canada and BioNTech to children ages 5 to 11.

For this age group, COMIRNATY should be given on a schedule of two doses given three weeks apart. The 10 mcg dose was chosen after careful selection based on data related to safety, tolerability, and immunogenicity. It is the first COVID-19 vaccine licensed in Canada for children ages 5 to under 12.

“We are very proud to share this news with Canadians today. It’s a day that many parents, concerned about protecting their young children against this virus, have been waiting for, says Fabien Paquette, Vaccine Leader, Pfizer Canada. With this approval from Health Canada, we have taken another important step in our ongoing efforts to help protect families and community members and control this disease. “

“Today’s authorization is supported by clinical data demonstrating its potential to address a public health need,” said Ugur Sahin, MD, CEO and co-founder of BioNTech. As 5-12 year olds approach the end of the year, both inside and outside of the classroom, our goal is to protect them and help them get back to normal. We will continue working to expand access to our vaccine, also for younger age groups ”.

Health Canada based its decision on data analysis from a randomized phase II / III comparative clinical study that included approximately 4,600 children aged 5 to less than 12 years (2,268 in the baseline group and 2,379 in the additional safety analysis subject). .

Shipping of 10 mcg doses for children to Canadian immunization centers will begin shortly, in collaboration with the Public Health Agency of Canada.

COMIRNATY (also known as Pfizer-BioNTech’s COVID-19 vaccine), which is based on BioNTech’s proprietary mRNA technology, was jointly developed by BioNTech and Pfizer.

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