SPIKEVAX (mRNA encoding SARS-CoV-2 spike protein, 5’(m7G-5’-ppp-5’-Gm) cap, 100-nucleotide 3' poly(A) tail) [KP.2 strain]

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

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.

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.