Importation of COVID-19 Vaccine Moderna with up to 15 Doses per Vial and English-only Vial and Carton Labels (US-Labelled Supply)

1. 1AudienceHealthcare professionals including infectious disease physicians, pharmacists, family physicians, public health officials, nurses and nurse practitioners, and healthcare professionals at identified points of use.
2. 2Innomar Strategies Inc. (the Canadian importer and distributor) is distributing COVID-19 Vaccine Moderna doses directly to vaccination locations where administration of the vaccine will occur, as outlined by provincial and territorial governments and public health authorities.
3. 3Key messagesFurther to the December 23, 2020 authorization of the COVID-19 Vaccine Moderna in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, ModernaTx, Inc. is providing US-labelled vaccine supplies with English-only vial and carton labels (see Appendix A, see images below) in order to expedite the distribution of the vaccine in Canada.
4. 4Moderna COVID-19 Vaccine with US labels is the same as the Health Canada authorized COVID-19 Vaccine Moderna in all aspects (i.e., formulation, strength, route of administration).
5. 5Healthcare professionals are advised that:The US-labelled supply is being offered in an 8 mL vial fill containing 14 doses (US label maximum 15 doses) of 0.5 mL each.

Labelling - New safety information - Packaging - Supply - COVID

Moderna COVID-19 Vaccine

Canada (national)Reported in the official notice — confirm there.

Health Canada — Marketed health products

RecallGuardian ranks, illustrates and rewrites recalls in plain language. The official notice is authoritative — confirm model numbers, lot codes, dates and remedies there.