Health Canada authorized SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) on November 3, 2022 . In order to provide rapid access to the vaccine, Moderna will distribute product vials and cartons labelled in English only with the brand name “ SPIKEVAX Bivalent Original / 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). Both Moderna bivalent COVID-19 vaccine presentations, SPIKEVAX Bivalent Original / Omicron BA.4/5 and SPIKEVAX Bivalent (targeting Original / Omicron BA.1), have the same royal blue vial cap as monovalent SPIKEVAX 0.10 mg/mL , 2.5 mL . The royal blue cap represents the 0.10 mg/mL product concentration and should NOT be used alone to identify the product. To avoid medication errors, pay careful attention to the vaccine name and the vial and carton labels . The vial and carton label of SPIKEVAX Bivalent Original / Omicron BA.4/BA.5 have a grey border and the concentration (0.1 mg/mL) is indicated in a grey band. The booster dose (50 mcg) and dose volume (0.5 mL) do not appear on the English-only vial and /or carton labels.
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