Approval · Notice of Compliance 38280 · 2026

COMIRNATY: Notice of Compliance 38280

Issued September 15, 2026

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number: 38280
Date: September 15, 2026
Company: Biontech Manufacturing GmbhMainz, Rheinland-Pfalz, Germany
Product type: Biologic
Submission: Supplement to a New Drug Submission (SNDS), supplement
Submission class: Other
Reason: Update to antigen composition (Omicron XFG variant)

Products in this notice

Brand	DIN	Status today
COMIRNATY	Not yet assigned	—

Medicinal ingredients

*SARSCOV2 S-PROTEIN MRNA, 5'[M27,3'-OGPPP(M12'-O)APG], 3'POLYA+LINKER 30 MCG per DOSE
*SARSCOV2 S-PROTEIN MRNA, 5'[M27,3'-OGPPP(M12'-O)APG], 3'POLYA+LINKER 3 MCG per DOSE
*SARSCOV2 S-PROTEIN MRNA, 5'[M27,3'-OGPPP(M12'-O)APG], 3'POLYA+LINKER 10 MCG per DOSE