UPDATED INFORMATION – June 10, 2022 Further to the communication below, issued on May 9, 2022, Health Canada has issued a new DIN (i.e. DIN 02527863) for COMIRNATY (COVID-19 Vaccine, mRNA), 30 mcg/0.3 mL, which has a GRAY vial cap and GRAY label border. Each presentation of COMIRNATY in Canada now has a distinct DIN: GRAY CAP and GRAY LABEL BORDER (DIN 02527863) PURPLE CAP and PURPLE LABEL BORDER (DIN 02509210) ORANGE CAP and ORANGE LABEL BORDER (DIN 02522454). The new DIN will help to mitigate potential medication errors between different presentations of COMIRNATY available in Canada. It will also facilitate tracking of product use by healthcare professionals. May 9, 2022 COMIRNATY received a Notice of Compliance (NOC) under the Food and Drug Regulations on September 16, 2021, replacing the previous authorization under the Interim Order. On March 15, 2022, COMIRNATY also received a NOC for an additional formulation/presentation (DIN 02522454) to be used in individuals 12 years of age and older. This new formulation/presentation does NOT require dilution. In addition, as an extraordinary measure to provide access to vaccine supplies in the context of the global pandemic, Pfizer and BioNTech are continuing to provide vaccine supplies with vials and cartons labelled with the name Pfizer-BioNTech COVID-19 Vaccine. This label is presented in English-only and is missing some important Canadian-specific information normally found on Health Canada approved labels (see the “Information for healthcare professionals” section).
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