On September 9, 2022 , Health Canada authorized a new presentation of COMIRNATY (COVID-19 Vaccine, mRNA) 3 mcg/0.2 mL dose ( DIN 02530325) for use in children aged 6 months to less than 5 years. This new presentation has a MAROON vial cap and MAROON label border. 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 (see Appendix A). 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).
RecallTracker