COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Presentation for Use in Children Aged 6 Months to Less Than 5 Years with English-only Vial and Carton Labels

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).

Audience

Healthcare professionals including infectious disease physicians, pharmacists, family physicians, public health officials, nurses and nurse practitioners. Healthcare professionals at vaccination sites.

Key Messages 

• On September 9, 2022, Health Canada authorized a NEW PRESENTATION of COMIRNATY (COVID-19 Vaccine, mRNA) 3 mcg/0.2 mL (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. It requires dilution with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use.
• Vials of COMIRNATY intended for children aged 6 months to less than 5 years (MAROON cap/ MAROON label border) cannot be used to prepare doses for individuals 5 years of age and older.
• COMIRNATY is now authorized as four different presentations, which are clearly differentiated by their vial cap and label border colours. Each presentation has specific age authorizations, storage, handling, and preparation requirements. The differences are noted in Table 1 in the “Information for healthcare professionals” section.
• Additionally, although the vaccine’s brand name is now COMIRNATY, Canada will continue to receive vials of the vaccine labelled as Pfizer-BioNTech COVID-19 Vaccine. Pfizer Canada ULC is providing vaccine supplies with US Emergency Use Authorization English-only labels on the vials and cartons to expedite the global distribution of COMIRNATY.
• Healthcare professionals are advised that:
  • It is important that information on the different presentations is carefully reviewed prior to use. The presentation and lot number should be documented on patient vaccine records and for the purposes of adverse reaction reporting.
  • Important Canadian-specific information is absent from the vial and carton labels (see the “Information for healthcare professionals” section).
  • The Canadian-specific labelling information, including the COMIRNATY Product Monograph and training materials can be accessed at CVDvaccine.ca or COMIRNATY.ca, or by scanning the QR code on the English-only carton label. This information is also available on the federal government’s covid-vaccine.canada.ca website. The COMIRNATY Canadian Product Monograph in English and French is also available in Health Canada’s Drug Product Database or at pfizer.ca.

Background information

COMIRNATY is now indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Vaccine vials intended for use in children 6 months to less than 5 years of age have a MAROON cap, and the vial labels also have a MAROON border. This new presentation requires dilution with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use.

Given the public health emergency resulting from the current pandemic, Health Canada has authorized the importation, sale, and advertising of this presentation with vial and carton labels that are in English only for the current global distribution of the vaccine.

The Canadian Product Monograph for COMIRNATY, which is approved by Health Canada and available in English and French, should be used for complete product information.

Information for healthcare professionals

COMIRNATY is now authorized as four different presentations (see Table 1):

• MAROON CAP AND MAROON LABEL BORDER
  • 3 mcg/0.2 mL after dilution
  • For use in children 6 months to less than 5 years of age
  • DIN 02530325
    
     
• ORANGE CAP AND ORANGE LABEL BORDER
  • 10 mcg/0.2 mL after dilution
  • For use in children 5 to less than 12 years of age
  • DIN: 02522454
    
     
• GRAY CAP AND GRAY LABEL BORDER
  • 30 mcg/0.3 mL – Do NOT dilute
  • For use in individuals 12 years of age and older
  • DIN: 02527863
    
     
• PURPLE CAP AND PURPLE LABEL BORDER
  • 30 mcg/0.3 mL after dilution
  • For use in individuals 12 years of age and older
  • DIN: 02509210

IMPORTANT: Each presentation has specific age authorizations, storage, handling, and preparation requirements. The differences are noted in Table 1.   

Only vials of COMIRNATY with MAROON caps and label borders are authorized to be used to prepare doses for children 6 months to less than 5 years of age.

Table 1: Important Differences between the Four COMIRNATY Presentations (adapted from the COMIRNATY Product Monograph)

Healthcare professionals are advised that:

• It is important that information on the different COMIRNATY presentations is carefully reviewed prior to use. The presentation and lot number should be documented on patient vaccine records and for the purposes of adverse reaction reporting.
• Canadian-specific information can be accessed on CVDvaccine.ca or COMIRNATY.ca, or by scanning the QR code on the carton label. This information is also available on the federal government’s covid-vaccine.canada.ca website. The COMIRNATY Canadian Product Monograph, which is available in English and French on Health Canada’s Drug Product Database, the federal government’s covid-vaccine.canada.ca website or at pfizer.ca, should be used for complete product information.
• The following important Canadian-specific information is absent from the vial and carton labels:
  • Drug Identification Number (DIN)
  • name and address of the Canadian DIN holder
  • name and address of the Canadian importer and distributor
  • all corresponding text in French
  • The “COMIRNATY” brand name
• The vial and/or carton labels for the current supplies of vaccine include the statements “For use under Emergency Use Authorization.” The US Food and Drug Administration (FDA) specific information (e.g., Rx only, NDC) should be disregarded as this is not relevant to the Canadian authorization.
• For any medical questions, contact Pfizer Canada ULC Medical Information at 1-800-463-6001.
• For any other general inquiries, contact Pfizer Canada ULC Customer Service at 1-833-VAX-COVI (1-833-829-2684) or email at CanadaCSVaccine@pfizer.com

Action taken by Health Canada

Health Canada is permitting the use of an English-only label for a limited period.  Health Canada has imposed terms and conditions requiring Pfizer Canada ULC to provide vaccine supplies with Canadian-specific labels as soon as feasible. Health Canada has made full labelling information available in English and French on the federal government’s covid-vaccine.canada.ca website.

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system, as well as through social media channels, including LinkedIn and Twitter.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any serious or unexpected side effects in patients receiving COMIRNATY should be reported to your local Health Unit or Pfizer Canada ULC.

Pfizer Canada ULC

17300 Trans-Canada Highway

Kirkland, QC

H9J 2M5

www.pfizersafetyreporting.com

Telephone: 1-866-723-7111

Fax: 1-855-242-5652

To correct your mailing address or fax number, contact Pfizer Canada ULC Customer Service at 1-833-VAX-COVI (1-833-829-2684).

If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory and send it to your local Health Unit.

For other health product inquiries related to this communication, contact Health Canada at:

Biologic and Radiopharmaceutical Drugs Directorate

E-mail: brdd.dgo.enquiries@hc-sc.gc.ca

Original signed by

Vratislav Hadrava M.D., Ph.D.

Vice President & Medical Director

Pfizer Canada ULC

Reference

1. COMIRNATY (COVID-19 Vaccine, mRNA) Product Monograph. Mainz (Germany): BioNTech Manufacturing GmbH; 2022.

Appendix A – Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY) for Children Aged 6 Months to less than 5 Years: MAROON Cap and Label Border - DILUTE PRIOR TO USE:  Vial and Carton Labels with English-only labelling

Vial Label 

Carton Label (10-vials)