On October 7, 2022 , Health Canada authorized 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) in individuals 12 years of age and older . In order to provide rapid access to COMIRNATY Original & Omicron BA.4/BA.5 bivalent vaccine , 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 02531461), which does NOT require dilution, has the same GRAY CAP AND GRAY LABEL BORDER as monovalent COMIRNATY (COVID-19 Vaccine, mRNA) 30 mcg/0.3 mL – Do NOT dilute (DIN: 02527863). To avoid medication errors, pay careful attention to the vial and carton label.
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