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Pfizer Canada and BioNTech Initiate Submission to Health Canada for COMIRNATY in Children Aged 5 to <12

18/10/21

October 18, 2021 - Pfizer Canada and BioNTech today filed a Supplemental New Drug Submission (sNDS) with Health Canada for use of COMIRNATY (Pfizer-BioNTech COVID-19 Vaccine) to prevent COVID-19 in children 5 to <12 years of age.

This submission is based on data from the Phase 2/3 trial of the Pfizer-BioNTech COVID-19 vaccine in children 5 to <12 years of age. The trial included 2,268 participants and used a two-dose regimen of 10 μg doses. These results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses. The 10 μg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age.

In Canada, COMIRNATY is currently approved for use in individuals aged 12 and older. Canadians may find more information about the vaccine at www.pfizerbiontechvaccine.ca. Canadian Health Care Professionals can visit www.cvdvaccine.ca for more information.

COMIRNATY (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.

For further information

Corporate Affairs Canada

1-866-9PFIZER (1-866-973-4937)

[email protected]