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Health Canada Health products

Distribution of SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels

Issued September 2, 2022
Issue
Health Canada authorized SPIKEVAX Bivalent (elasomeran/imelasomeran) on September 01, 2022 . In order to provide rapid access to SPIKEVAX Bivalent , Moderna will distribute product vials and cartons labelled in English only with the brand name “ SPIKEVAX 0 (Zero) / O (Omicron)” for a period of time . As a result, important Canadian-specific information is absent from these labels (see the Information for healthcare professionals section). The bivalent SPIKEVAX TM 0 (Zero) / O (Omicron), 0.10 mg/mL, 2.5 mL shares the same coloured vial cap (royal blue) to monovalent SPIKEVAX 0.10 mg/mL , 2.5 mL. To avoid medication errors, pay careful attention to the vial and carton label .
Hazard description
Labelling - Packaging - Product safety - COVID
Product
Product name
SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine
Reference
ID
RA-64527