COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Formulation for Use in Children Aged 5 Years to Less Than 12 Years

IMPORTANT: Access to Canadian-specific labelling information during the distribution of COMIRNATY (COVID-19 Vaccine, mRNA also referred to as Pfizer-BioNTech COVID-19 Vaccine) for Children Aged 5 Years to Less Than 12 Years.

 

Audience

Healthcare professionals including infectious disease physicians, pharmacists, family physicians, public health officials, nurses and nurse practitioners. Healthcare professionals at the identified Points of Use.

 

Key messages

• On 19 November 2021, COMIRNATY (COVID-19 Vaccine, mRNA), DIN: 02522454, received a Notice of Compliance for a new formulation to be used in children 5 to less than 12 years of age.
• 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 5 years of age and older.
• COMIRNATY is now authorized as two different formulations/presentations, which are clearly differentiated by their cap colour (see Appendix A and Appendix B):
  • PURPLE CAP (30 mcg/0.3 mL after dilution): for use in individuals 12 years of age and older;
  • ORANGE CAP (10 mcg/0.2 mL after dilution): for use in children 5 to less than 12 years of age. Labels for this formulation also have an orange border.  
• Each formulation has specific age authorizations, storage, handling, and preparation requirements and it is important that these be reviewed carefully prior to use (see Tables 1 and 2 in the “Information for healthcare professionals” section). The formulation and lot number should be documented on patient vaccine records and for the purposes of adverse reaction reporting.
• Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap) are not authorized to be used to prepare doses for children 5 to less than 12 years of age.
• Vials of COMIRNATY intended for children 5 to less than 12 years of age (orange cap) should be discarded 12 hours after dilution (i.e., the first puncture). Vial labels and cartons may state that a vial should be discarded 6 hours after dilution, however, additional testing has been completed to support 12 hours of stability after dilution.
• 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:
  • 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 French and English is also available on Health Canada’s Drug Product Database or at pfizer.ca.

 

What is the issue?

COMIRNATY (COVID-19 Vaccine, mRNA) was issued the initial Notice of Compliance (NOC) under the Food and Drug Regulations on September 16, 2021, replacing the previous authorization under the Interim Order.

On 19 November 2021, COMIRNATY (COVID-19 Vaccine, mRNA) also received an NOC for a new formulation (DIN 02522454) to be used in children 5 to less than 12 years of age.

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).

 

Products affected

COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine) for Age 5 Years to <12 Years, suspension for intramuscular injection, multiple dose vials. Each vial contains 10† doses (each dose is 0.2 mL).

DIN: 02522454

Manufacturer: BioNTech Manufacturing GmbH (Germany)  

Canadian Importer and Distributor: Pfizer Canada ULC

† Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10  doses from a single vial.

 

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 5 years of age and older. 

COMIRNATY is now authorized as two different formulations and presentations, clearly differentiated by the colour of the vial cap. Vials intended for use in children 5 to less than 12 years of age have an orange cap, and the vial labels also have an orange border.

Given the public health emergency resulting from the current pandemic, Health Canada has authorized the importation, sale, and advertising of COMIRNATY for Age 5 Years to <12 Years with vial and carton labels that are in English-only for the current global distribution of the vaccine.

All other aspects of COMIRNATY for Age 5 Years to <12 Years with English-only labels (i.e., formulation, strength, route of administration) remain unchanged from the Health Canada authorized COMIRNATY for Age 5 Years to <12 Years. The Canadian Product Monograph for COMIRNATY, which is approved by Health Canada and available in French and English, should be used for complete product information.

 

Information for healthcare professionals

COMIRNATY is now authorized as two different formulations and presentations (see Appendix A and Appendix B):

1. For individuals 12 years of age and older: purple cap
2. For children 5 to less than 12 years of age: orange cap and orange border on label

IMPORTANT: Each formulation has specific age authorizations, storage, handling, and preparation requirements. The differences are noted in Table 1 below and it is important that this information be carefully reviewed prior to use. The formulation and lot number should be documented on patient vaccine records and for the purposes of adverse reaction reporting.   

Children 5 to less than 12 years of age should be vaccinated with the vial labelled “DILUTE PRIOR TO USE Age 5y to <12y” (orange cap). 

Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap) are not authorized to be used to prepare doses for children 5 to less than 12 years of age. Individuals 12 years and older can continue to be vaccinated with the purple cap presentation.

 

Table 1: Important Differences between the two COMIRNATY Formulations/Presentations¹

Important reminders relating to Table 1 above:

• Diluent: ONLY USE sterile 0.9% Sodium Chloride Injection, USP.
• 5 to <12 years of age formulation (orange cap): regardless of storage condition, vaccines should not be used after 6 months from the date of manufacture printed on the vial and cartons.
• The above information is subject to change, please always refer to CVDvaccine.ca or COMIRNATY.ca for up-to-date information.

The intended long-term storage condition for COMIRNATY for Age 5 Years to <12 Years is 6 months at -90°C to -60°C. The labels do not include an expiration date. Once received, frozen vials may be immediately transferred to the refrigerator, thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. The vaccine should be used within 6 months from the date of manufacture printed on the vials and cartons, as shown in the table below (also available at CVDvaccine.ca and COMIRNATY.ca):

Table 2: COMIRNATY for Age 5 Years to <12 Years Expiry Information

COMIRNATY for Age 5 Years to <12 Years vials (orange cap) should be discarded 12 hours after dilution (i.e., the first puncture). Vial labels and cartons may state that a vial should be discarded 6 hours after dilution, however, additional testing has been completed to support 12 hours of stability after dilution. The information in the Product Monograph and this communication supersedes the number of hours printed on vial labels and cartons.

As previously noted, to provide timely access to COMIRNATY for Canadians, Pfizer and BioNTech will continue to provide product vials and cartons labelled in English-only for now.  

Healthcare professionals are advised that:

• Canadian-specific information can be accessed on CVDvaccine.ca or COMIRNATY.ca, or by scanning the QR code on carton label. This information is also available on the federal government’s covid-vaccine.canada.ca website. The COMIRNATY Canadian Product Monograph in French and English is also available on Health Canada’s Drug Product Database or at pfizer.ca.

• 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 that reflects the US label for emergency use 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 French and English 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 Pfizer Canada ULC or your local Health Unit.

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 (https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization/form.html) 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; 2021.

 

Appendix A

COMIRNATY (Pfizer-BioNTech COVID-19 Vaccine) for children 5 to <12 years of age Vial and carton labels with English-only labelling

VIAL (Orange Cap)

 

CARTON (10-Vial)

Front Panel

 

Appendix B

COMIRNATY (Pfizer-BioNTech COVID-19 Vaccine) for individuals 12 years of age and older Vial and carton labels with English-only labelling

VIAL (Purple Cap)

 

Carton (195-Vial)