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

UPDATED INFORMATION – October 29, 2021 Further to the Health Canada communications below issued on June 14, 2021 (and updated on June 24, 2021, and August 3, 2021), Health Canada has authorized a 2-month shelf life extension (from 7 months to 9 months) for certain lots of the SPIKEVAX (previously COVID-19 Moderna vaccine). This extension applies to lots of US-labelled vaccine supplies with English-only vial and carton labels. These lots with their extended expiry dates are identified in the “Products Affected” section in the table below. One previously listed lot (015E21A) has been removed from the table because it was not distributed in Canada. SPIKEVAX (previously COVID-19 Moderna vaccine) has now been issued a Notice of Compliance under the Food and Drug Regulations, replacing the previous authorization under the Interim Order. The vaccine is now authorized under the brand name SPIKEVAX (elasomeran mRNA vaccine), for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. UPDATED INFORMATION – August 3, 2021 Further to the Health Canada communication below, issued on June 14, 2021 (and updated on June 24, 2021), ModernaTx, Inc. is providing one additional lot (016F21A) of US-labelled vaccine supplies with English-only vial and carton labels in order to expedite the distribution of the vaccine in Canada. Please refer to the updated table in the ‘Products Affected’ section below for details related to the newly added lot. One previously listed lot (058D21A) has been removed from the table because it was not distributed in Canada. UPDATED INFORMATION - June 24, 2021 Further to the Health Canada communication below, issued on June 14, 2021, ModernaTx, Inc. is providing 9 additional lots of US-labelled vaccine supplies with English-only vial and carton labels in order to expedite the distribution of the vaccine in Canada. The US-labelled vaccine, named ‘Moderna COVID-19 Vaccine’, continues to be supplied in a carton of 10 multiple-dose vials with 8 mL fill volume that contain a greater number of doses (14 doses (with US label max. 15 doses)). Please refer to the updated table in the ‘Products Affected’ section below for details related to the new lots added.

Labelling - New safety information - Packaging - Supply - COVID

Audience Healthcare professionals including infectious disease physicians, pharmacists, family physicians, public health officials, nurses and nurse practitioners, and healthcare professionals at identified points of use. Innomar 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.

Moderna COVID-19 Vaccine

RA-62511