Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized COMIRNATY® Original & Omicron BA.4/BA.5 as a 10-μg booster dose for children 5 through <12 years of age. This booster is approved for use at least 6 months after completing the primary course of the companies' original COVID-19 vaccine (COMIRNATY).
The authorization of the bivalent COVID-19 vaccine for children 5 through <12 years of age is supported by safety and immunogenicity data from the companies' original COVID-19 vaccine, data from the companies' 30-µg Omicron BA.1-adapted bivalent vaccine, manufacturing data from the companies' 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and non-clinical and clinical data from the companies' 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine.
The Pfizer-BioNTech COVID-19 Vaccines are based on BioNTech's proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Original and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, 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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