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

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Resources
Additional Information About COMIRNATY LP.8.1, COMIRNATY JN.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) 12 years of age and older, Ready to use, JN.1 (COMIRNATY JN.1 (30 micrograms)/dose, Grey Cap) 5 to 11 years old, Ready to use, LP.8.1 (COMIRNATY LP.8.1 (10 micrograms)/dose, Blue Cap) 5 to 11 years old, Ready to use, JN.1 (COMIRNATY JN.1 (10 micrograms)/dose, Blue Cap) 6 months to 4 years old, Dilute to use, LP.8.1 (COMIRNATY LP.8.1 (3 micrograms)/dose, Yellow Cap) 6 months to 4 years old, Dilute to use, JN.1 (COMIRNATY JN.1 (3 micrograms)/dose, Yellow Cap)

Package Leaflet

 12 years and older, Ready to use, LP.8.1 (COMIRNATY LP.8.1 (30 micrograms)/dose, Grey Cap) 12 years and older, Ready to use, JN.1 (COMIRNATY JN.1 (30 micrograms)/dose, Grey Cap) 5 to 11 years old, Ready to use, LP.8.1 (COMIRNATY LP.8.1 (10 micrograms)/dose, Blue Cap) 5 to 11 years old, Ready to use, JN.1 (COMIRNATY JN.1 10 micrograms/dose, Blue Cap) 6 months to 4 years old, Dilute to use, LP.8.1 (COMIRNATY LP.8.1 (3 micrograms/dose, Yellow Cap) 6 months to 4 years old, Dilute to use, JN.1 (COMIRNATY JN.1 (3 micrograms/dose, Yellow 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
12 years of age and older, Ready to use, JN.1
5 to 11 years old, Dilute to use, LP.8.1
5 to 11 years old, Dilute to use, JN.1
6 months to 4 years old, Dilute to use, LP.8.1
6 months to 4 years old, Dilute to use, JN.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.

©2025 Pfizer Inc. All rights reserved. August 2025.PP-CMR-EST-0055


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