O n December 9 , 2022, He alth Canada authorized a new formulation of the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for use in children 5 to less than 12 years of age . In order to provide rapid access to the new formulation, Pfizer Canada ULC will distribute product vials and cartons labelled in English-only with the name “Pfizer-BioNTech COVID-19 Vaccine, Bivalent Original and Omicron BA.4/BA.5” for a period of time . Important Canadian-specific information is absent from these labels (see the “Information for healthcare professionals” section). COMIRNATY Original & Omicron BA.4/BA.5 bivalent vaccine (DIN 02533197 ) has the same ORANGE CAP and ORANGE LABEL BORDER as monovalent COMIRNATY (COVID-19 Vaccine, mRNA) 10 mcg/0.2 mL (DIN 02522454). To avoid medication errors, pay careful attention to the vial and carton label.
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