A new formulation of COMIRNATY “12 years of age and older, Ready to use (monovalent Omicron XBB.1.5 Grey Cap and Package, Single-dose or Multi-dose vial)” was approved on 31/08/23 with procedure II/0183.

A new formulation of COMIRNATY “5 to 11 years of age, Ready to use (monovalent Omicron XBB.1.5 Blue Cap and Package, Multi-dose vial)” was approved on  31/08/23 with procedure II/0183.

A new formulation of COMIRNATY “6 months to 4 years of age, Dilute to use (monovalent Omicron XBB.1.5 Maroon Cap and Package, Multi-dose vial)” was approved on  31/08/23  with procedure II/0183.

COMIRNATY Omicron XBB.1.5 (30 micrograms)/dose for dispersion for injection, for 12 years of age and older, Ready to use (Omicron XBB.1.5 Grey Cap and Package, Single-dose of Multi-dose vial)

COMIRNATY Omicron XBB.1.5 (5/5 micrograms)/dose for dispersion for injection, for 5 to 11 years of age, Ready to use (Omicron XBB.1.5 Blue Cap and Package, Multi-dose vial)

COMIRNATY Omicron XBB.1.5 (3 micrograms)/dose for dispersion for injection, for 6 months to 4 years of age, Dilute to use (Omicron XBB.1.5 Maroon Cap and Package, Multi-dose vial)

PP-CMR-EST-0039

This site is intended for Healthcare Professionals.

Resources
Additional Information About COMIRNATY LP.8.1

Summary of Product Characteristics

 12 years of age and older, Ready to use, LP.8.1 (COMIRNATY LP.8.1 (30 micrograms)/dose, Grey Cap) 6 months to 11 years old, Ready to use, LP.8.1 (COMIRNATY LP.8.1 (10 micrograms)/dose, Blue Cap)

Package Leaflet

 12 years and older, Ready to use, LP.8.1 (COMIRNATY LP.8.1 (30 micrograms)/dose, Grey Cap) 6 months to 11 years old, Ready to use, LP.8.1 (COMIRNATY LP.8.1 (10 micrograms)/dose, Blue Cap)
Safety and StorageExpiry Date information DOWNLOAD Dry Ice Replenishment Sheet DOWNLOAD Shipping and Handling Guidelines DOWNLOAD Product Safety Data Sheet
Dilute to use, 12 years and older

 VIEW Product Safety Data Sheet

12 years of age and older, Ready to use, LP.8.1
6 months to 11 years old, Dilute to use, LP.8.1
 VIEW Dry Ice Safety Data Sheet VIEW
For more information ​​​​​​​

Contact: +372 666 7500

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH
​​​​​​​

COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified), which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

©2026 Pfizer Inc. All rights reserved. June 2026. PP-CMR-EST-0059


SmPC Updates

Updated posology

Updates to Summary of Product Characteristics include the following:

- Deletion of COMIRNATY 3mcg formulation from SmPC.
- New posology for infants 6 months to 4 years of age.

For details, please refer to Summary of Product Characteristics for each formulation. 

Current inventory of COMIRNATY 3mcg can continue to be used until the expiry date on the carton and vial. SmPC and Package Leaflet for the 3mcg formulation can be accessed here:

SmPC: 6 months to 4 years old, Dilute to use, LP.8.1 3 mcg/dose, Yellow Cap

Package Leaflet: 6 months to 4 years old, Dilute to use, LP.8.1 3 mcg/dose, Yellow Cap