|Updated Date||Resources for||Resources||Description||Date|
|Consumers, Health Care Professionals||Consumer Information||
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.
|Health Care Professionals, Researchers||Product Monograph||
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:
|Health Care Professionals||Interim Product Label||
Vial and carton labels for Moderna COVID-19 Vaccine with English-only labelling. These labels are used for the initial supply of vaccine.
|Health Care Professionals||Canadian Reference Label||
The Canadian reference labels for the vial and carton labels. These labels provide information specific to Canada in both French and English and can be used as reference until the manufacturer implements them on the Canadian-specific product vial and carton.
|Consumers||Regulatory Decision Summary||
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.
|Health Care Professionals, Researchers||Summary Basis of 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.
|Health Care Professionals, Researchers||Post-Authorization Activity Table (PAAT)||
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 Care Professionals, Researchers||Health Product Risk Communications||
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. The most recent communication can be found here. All Health Product Risk Communications are posted in Health Canada’s recalls and safety alerts database and can be found by clicking on the "Advisories" section.
|Consumers, Health Care Professionals, Researchers||Adverse Events Following Immunization||
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.
|Health Care Professionals, Researchers||Risk Management Plan||
The Company’s Risk Management Plan describes:
Clicking on the link will take you to a summary of the Risk Management Plan. The Risk Management Plan may be updated following authorization. The most recent version (available only in the language in which it was submitted) can be requested by email to [email protected]
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.
|Health Care Professionals, Researchers||Authorization Terms & Conditions||
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.
|Consumers, Health Care Professionals, Researchers||Advisories||
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.
|Health Care Professionals||Storage, handling, and administration||
The steps to Moderna COVID-19 Vaccination. Your guide to proper storage, handling, and administration for the Moderna COVID-19 Vaccine.