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Resources for Canadian Healthcare Professionals and Patients

The use of COVID‑19 Vaccine Moderna is permitted under an interim authorization delivered in accordance with section 5 of the COVID‑19 Interim Order (IO). Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID‑19.

The current COVID‑19 Vaccine Moderna vial and carton labels are not Canadian-specific as global, English-only labels are being used for the Canadian market.

For more information, please see the Health Product Risk Communications below.

COVID‑19 Vaccine Moderna (mRNA‑1273 SARS‑CoV‑2 vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID‑19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) virus in individuals 18 years of age and older.

Please find helpful resources for COVID‑19 Vaccine Moderna below. Check back as we update with additional educational content as it becomes available.

Drug Identification Number (DIN): 02510014

Helping Patients
Understand
What to Expect

Storage, Handling, Dosage
and Administration

2nd Dose
Reminder Card

U.S. Moderna COVID-19 Vaccine Lots and Expiry Dates

Product
Monograph

June 30, 2021

What is the mRNA Vaccine Platform

What Is the mRNA Vaccine Platform?

FOR HEALTHCARE PROFESSIONALS

The use of COVID‑19 Vaccine Moderna is permitted under an interim authorization delivered in accordance with section 5 of the COVID‑19 Interim Order (IO). Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID‑19.

The current COVID‑19 Vaccine Moderna vial and carton labels are not Canadian-specific as global, English-only labels are being used for the Canadian market.

For more information, please see the Health Product Risk Communication.

COVID‑19 Vaccine Moderna (mRNA‑1273 SARS‑CoV‑2 vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID‑19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) virus in individuals 18 years of age and older.

FIGURE 1. THE CENTRAL DOGMA

No adjuvants or preservatives
Can be stored under refrigeration for up to 30 days prior to first use
No dilution required

Important Safety Information
Contraindications
COVID‑19 Vaccine Moderna is contraindicated in individuals who are hypersensitive to the active ingredient or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and Precautions
The clinical data available for COVID‑19 Vaccine Moderna are derived from the COVE Phase 3 study and Phase 1 and Phase 2 studies. Serious and unexpected adverse events may occur that have not been previously reported with COVID‑19 Vaccine Moderna use. As with any vaccine, vaccination with COVID‑19 Vaccine Moderna may not protect all recipients. Individuals may not be optimally protected until after receiving the second dose of the vaccine.

Hypersensitivity and Anaphylaxis
Anaphylaxis has been reported. As with all vaccines, appropriate medical treatment, training for immunizers and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. Vaccine recipients should be kept under observation for at least 15 minutes after immunization; 30 minutes is a preferred interval when there is a specific concern about a possible vaccine reaction. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of COVID‑19 Vaccine Moderna.

Acute illness
Consideration should be given to postponing immunization in persons with severe febrile illness or severe acute infection. Persons with moderate or severe acute illness should be vaccinated as soon as the acute illness has improved.

Hematologic-Bleeding
As with other intramuscular injections, COVID‑19 Vaccine Moderna should be given with caution in individuals with bleeding disorders, such as haemophilia, or individuals currently on anticoagulant therapy, to avoid the risk of haematoma following the injection, and when the potential benefit clearly outweighs the risk of administration.

Immune
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.

Syncope
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.

Reporting Adverse Events
Managing marketed health product-related side effects depends on healthcare professionals and patients reporting them. Any serious or unexpected side effects in patients receiving COVID‑19 Vaccine Moderna should be reported to your local Health Unit.

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.

In addition, you can report side effects to Moderna at 1‑866‑MODERNA (1‑866‑663‑3762).

Product Concerns
All designated vaccination sites need to maintain security around the storage of COVID‑19 Vaccine Moderna within their facilities.

Make sure that vials of COVID‑19 Vaccine Moderna arrive and are stored in their original packaging. If you suspect that the COVID‑19 Vaccine Moderna you have purchased may be counterfeit, if there are any irregularities with packaging, and/or with the arrival of the shipments, please contact us at 1‑866‑663‑3762 or visit www.modernatx.com, or report a complaint to Health Canada.

moderna

ModernaTX.com

CA-COV-2100003 04/2021

Storage & Handling
COVID‑19 Vaccine Moderna Video

Storage and Handling COVID‑19 Vaccine Moderna

FOR HEALTHCARE PROFESSIONALS

The use of COVID‑19 Vaccine Moderna is permitted under an interim authorization delivered in accordance with section 5 of the COVID‑19 Interim Order (IO). Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID‑19.

The current COVID‑19 Vaccine Moderna vial and carton labels are not Canadian-specific as global, English-only labels are being used for the Canadian market.

For more information, please see the Health Product Risk Communication.

COVID‑19 Vaccine Moderna (mRNA‑1273 SARS‑CoV‑2 vaccine) is indicated for active immunization against coronavirus disease 2019 (COVID‑19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) virus in individuals 18 years of age and older.

Shipped Frozen

Frozen storage Freezer temperature
–25° to –15° C
(–13° to 5° F)
Do not store on dry ice or below -40° C (-40° F)
Store in the original carton to protect them from light

Thaw vial before administration
Refrigerator
2 hours and 30 minutes
2° to 8°C (36° to 46°F)
Let vial stand at room temperature for 15 minutes before administering.
Do not refreeze once thawed
Do not shake or dilute.

Room temperature
1 hour
15° to 25°C (59° to 77°F)
Do not refreeze once thawed.
Do not shake or dilute.

Unpunctured vials
Store refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days.
Store between 8° to 25°C (46° to 77°F) for up to 12 hours.
Do not refreeze once thawed.
Do not shake or dilute.

Punctured vials For illustrative purposes only
Do not shake or dilute
Punctured vials should be held between 2° to 25°C (36° to 77°F).
Discard vial after 6 hours.
Do not refreeze once thawed.
Do not shake or dilute.

COVID‑19 VACCINE MODERNA THAWING & STORAGE

  • FROZEN STORAGE PRIOR TO USE
    • COVID‑19 Vaccine Moderna multidose vials are stored frozen between -25° to -15°C (-13° to 5°F).
  • THAWING
    • Thaw in refrigerated conditions between 2° to 8°C (36° to 46°F) for 2 hours and 30 minutes. Let vial stand at room temperature for 15 minutes before administering. Alternatively, thaw at room temperature between 15° to 25°C (59° to 77°F) for 1 hour.
  • REFRIGERATED STORAGE PRIOR TO USE
    • Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Do not refreeze once thawed. Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours. Do not refreeze once thawed.
  • STORAGE AFTER FIRST PUNCTURE OF THE VACCINE VIAL
    • After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Discard vial after 6 hours. Do not refreeze.

Important Safety Information
Contraindications
COVID‑19 Vaccine Moderna is contraindicated in individuals who are hypersensitive to the active ingredient or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and Precautions
The clinical data available for COVID‑19 Vaccine Moderna are derived from the COVE Phase 3 study and Phase 1 and Phase 2 studies. Serious and unexpected adverse events may occur that have not been previously reported with COVID‑19 Vaccine Moderna use. As with any vaccine, vaccination with COVID‑19 Vaccine Moderna may not protect all recipients. Individuals may not be optimally protected until after receiving the second dose of the vaccine.

Hypersensitivity and Anaphylaxis
Anaphylaxis has been reported. As with all vaccines, appropriate medical treatment, training for immunizers and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. Vaccine recipients should be kept under observation for at least 15 minutes after immunization; 30 minutes is a preferred interval when there is a specific concern about a possible vaccine reaction. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of COVID‑19 Vaccine Moderna.

Acute illness
Consideration should be given to postponing immunization in persons with severe febrile illness or severe acute infection. Persons with moderate or severe acute illness should be vaccinated as soon as the acute illness has improved.

Hematologic-Bleeding
As with other intramuscular injections, COVID‑19 Vaccine Moderna should be given with caution in individuals with bleeding disorders, such as haemophilia, or individuals currently on anticoagulant therapy, to avoid the risk of haematoma following the injection, and when the potential benefit clearly outweighs the risk of administration.

Immune
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.

Syncope
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from fainting and manage syncopal reactions.

Reporting Adverse Events
Managing marketed health product-related side effects depends on healthcare professionals and patients reporting them. Any serious or unexpected side effects in patients receiving COVID‑19 Vaccine Moderna should be reported to your local Health Unit.

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.

In addition, you can report side effects to Moderna at 1‑866‑MODERNA (1‑866‑663‑3762).

Product Concerns
All designated vaccination sites need to maintain security around the storage of COVID‑19 Vaccine Moderna within their facilities.

Make sure that vials of COVID‑19 Vaccine Moderna arrive and are stored in their original packaging. If you suspect that the COVID‑19 Vaccine Moderna you have purchased may be counterfeit, if there are any irregularities with packaging, and/or with the arrival of the shipments, please contact us at 1‑866‑663‑3762 or visit www.modernatx.com, or report a complaint to Health Canada.

moderna

ModernaTX.com

CA-COV-2100005 04/2021

Reporting Adverse Events

Managing marketed health product-related side effects depends on healthcare professionals and patients reporting them. Any serious or unexpected side effects in patients receiving COVID‑19 Vaccine Moderna should be reported to your local Health Unit.

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.

In addition, you can report side effects to Moderna at 1-866-MODERNA (1-866-663-3762).

Product Concerns

All designated vaccination sites need to maintain security around the storage of COVID‑19 Vaccine Moderna within their facilities.

Make sure that vials of COVID‑19 Vaccine Moderna arrive and are stored in their original packaging. If you suspect that the COVID‑19 Vaccine Moderna you have purchased may be counterfeit, if there are any irregularities with packaging, and/or with the arrival of the shipments, please contact us at 1‑866‑663‑3762 or visit www.modernatx.com, or report a complaint to Health Canada.