Pfizer Canada and BioNTech announced that Health Canada authorized COMIRNATY®, the companies' COVID-19 vaccine, as a three 3-μg primary series for children 6 months to less than 5 years of age.
The 3-μg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data.
"We know many parents in Canada have at heart to provide further protection for their children under 5," said Fabien Paquette, mRNA Vaccines & Antiviral Portfolio Lead, Pfizer Canada. "With this Health Canada authorization, we have achieved another key milestone in our ongoing effort to help protect families and communities against COVID-19."
"We are committed to providing access to our COVID-19 vaccine to all age groups," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "As of today, Canadian families have access to an authorized vaccine helping to protect their youngest children against COVID-19."
Health Canada's authorization is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to under 5 years of age. In the trial, children received the third 3-μg dose at least two months after the second dose at a time when Omicron was the predominant variant.
Pfizer and BioNTech will begin shipping 3-μg pediatric doses as directed by the Canadian government and public health agencies across the country.
COMIRNATY, also referred to as Pfizer-BioNTech COVID-19 Vaccine, is based on BioNTech's proprietary mRNA technology. BioNTech is the Marketing Authorization Holder in Canada, the United States, the European Union, 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.
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