Moderna COVID-19 Vaccine (mRNA-1273 SARS-CoV-2)

Information about the product including what the product is used for, dosage, warnings, proper use and side effects.  This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.

The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use.

The Product Monograph includes three sections:

• Part I: Health Professional Information;
• Part II: Scientific Information; and
• Patient Medication Information

Vial and carton labels for Moderna COVID-19 Vaccine with English-only labelling.

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.

The Post Authorization Activity Table includes brief summaries of the activities that occur after the approval of the product. It is updated on a monthly basis.

Health Product Risk Communications are published to inform healthcare professionals about issues that can include the safety, or effectiveness, of a health product. It is a communication issued by the market authorization holder containing content approved by Health Canada. All Health Product Risk Communications are posted in Health Canada’s recalls and safety alerts database.

Information about adverse events following immunization. An adverse event is a medical incident that may occur following immunization. The cause is not necessarily related to the vaccine.

The Company’s Risk Management Plan describes:

• Known and potential safety issues
• The company’s monitoring plan, including plans for collection of additional safety and effectiveness information
• Any measures that will be put in place to minimize risks associated with the product.

To be published before March 31, 2021.

After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes.

To be published before March 31, 2021.

For COVID-19 authorizations, Health Canada can impose specific terms and conditions on the authorization. This allows Health Canada to continue to gather information on the safety, effectiveness and/or quality of the product as more studies are completed.

Advisories are published when Health Canada has important updates or other information to share about the product, such as information on shortages, new approvals, or risks.

Clicking the link will retrieve any advisories Health Canada has issued about the product. If no advisories have been issued, no results will be returned.

The steps to Moderna COVID-19 Vaccination. Your guide to proper storage, handling, and administration for the Moderna COVID-19 Vaccine.