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Pfizer Canada and BioNTech initiate rolling submission to Health Canada for COMIRNATY in children 6 months to < 5 years of age

23/06/22

June 23, 2022 – 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 6 months to < 5 years of age.

In Canada, COMIRNATY is currently approved for use in individuals aged 5 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]