SPIKEVAX Bivalent Original / Omicron BA.4/5

Product description

Brand name
SPIKEVAX Bivalent Original / Omicron BA.4/5
Company name
ModernaTX, Inc.
elasomeran/ davesomeran
Date of approval


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Updated Date Resources for Resources Description Date
Consumers, Health Care Professionals

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

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
Health Care Professionals

Vial and carton labels with English-only labelling. These labels are used for the initial supply of vaccine.


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

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

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

For COVID-19 authorizations, Health Canada can impose 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. The status of the terms and conditions will be updated on a regular basis.

Consumers, Health Care Professionals, Researchers

Public Advisories and Health Product Risk Communications are two ways that Health Canada communicates safety issues. They are published when Health Canada has important updates or other information to share about the product, such as new approvals, information on shortages, or risks.

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

Health Care Professionals

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