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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

A Marketing Authorisation (MA) has been granted in the EU:

for the product COMIRNATY KP.2 COVID-19 mRNA Vaccine (nucleoside modified) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years (3 micrograms/dose), children aged 5 to 11 years (10 micrograms/dose), and individuals 12 years of age and older (30 micrograms/dose)
for the product COMIRNATY JN.1 COVID-19 mRNA Vaccine (nucleoside modified) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years (3 micrograms/dose), children aged 5 to 11 years (10 micrograms/dose), and individuals 12 years of age and older (30 micrograms/dose)
for the product COMIRNATY Omicron XBB.1.5 COVID-19 mRNA Vaccine (nucleoside modified) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years (3 micrograms/dose), children aged 5 to 11 years (10 micrograms/dose), and individuals 12 years of age and older (30 micrograms/dose)

Detailed information on this medicine is available on the EMA website

SmPC Update: Variation EMA/VR/0000248834 , effective 12/03/2025

Vaccine Formulations Guide

Refer to the information outlined below and continue to scroll to understand the differences across age groups and available formulations

Formulation and Name of the Medicinal Product	12 years of age and older, Ready to use	5 to 11 years old, Ready to use	6 months to 4 years old, Dilute to use
Vial Cap Color & Formulations	JN.1	JN.1	JN.1
Dosage	JN.1: 30 mcg of bretovameran	JN.1: 10 mcg of bretovameran	JN.1: 3 mcg of bretovameran
Injection Volume per Dose	0.3 mL	0.3 mL	0.3 mL
Dilution	NO DILUTION	NO DILUTION	Dilution required
Amount of Diluent Needed per Vial*	NO DILUTION	NO DILUTION	1.1 mL
Doses per Vial	Single dose vial contains 1 dose OR Multi-dose vial contains 6 doses	Single dose vial contains 1 dose OR Multi-dose vial contains 6 doses	3 doses per vial (after dilution)
Fill Volume per Vial	2.25 mL for multi-dose vial	2.25 mL for multi-dose vial	0.48 mL
Ultra-Low-Temperature (ULT) Freezer(-90 °C to -60 °C)	JN.1: 18 months of (shelf-life)	JN.1: 18 months (shelf-life)	JN.1: 18 months (shelf-life)
Freezer Storage Time(-25 °C to -15 °C)	DO NOT STORE	DO NOT STORE	DO NOT STORE
Refrigeration Storage Time(2 °C to 8 °C)	10 weeks	10 weeks	10 weeks
Room Temperature(8 °C to 30 °C)	12 hours prior to first puncture (including any thaw time)	12 hours prior to first puncture (including any thaw time)	12 hours prior to dilution (including any thaw time)
After First Puncture(2 °C to 30 °C)	Discard after 12 hours	Discard after 12 hours	Discard after 12 hours

*Diluent: sterile sodium chloride 9 mg/mL (0.9%) solution for injection. Bacteriostatic saline or other diluents must NOT be used.

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Ensuring the Authenticity of COMIRNATY

Pfizer is committed to patient safety and ensuring that people have accurate information about COMIRNATY, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate COMIRNATY to protect patients from products that might be dangerous and lead to serious and life-threatening harm
o COMIRNATY is only administered intramuscularly by government-authorised healthcare professionals
o COMIRNATY is not taken orally and is not available in a capsule or tablet form
Authentic COMIRNATY, manufactured by Pfizer or BioNTech, will include the COMIRNATY name on the label and is dispensed in a vial as follows:
o with a grey cap and border for 12 years of age and older, Ready to use, KP.2
o with a grey cap and border for 12 years of age and older, Ready to use, JN.1
o with a grey cap and border for 12 years of age and older, Ready to use, Omicron XBB.1.5
o with an orange cap and border for 5 to 11 years old, Dilute to use, JN.1
o with an orange cap and border for 5 to 11 years old, Dilute to use, Omicron XBB.1.5
o with a blue cap and border for 5 to 11 years old, Ready to use, KP.2
o with a blue cap and border for 5 to 11 years old, Ready to use, JN.1
o with a blue cap and border for 5 to 11 years old, Ready to use, Omicron XBB.1.5
o with a yellow cap and border for 6 months to 4 years old, Dilute to use, KP.2
o with a yellow cap and border for 6 months to 4 years old, Dilute to use, JN.1
o with a maroon cap and border for 6 months to 4 years old, Dilute to use, JN.1
o with a maroon cap and border for 6 months to 4 years old, Dilute to use, Omicron XBB.1.5
COMIRNATY is not available for private purchase. COMIRNATY is NOT sold online. Any sales of COMIRNATY over the internet, including from online pharmacies, are not legitimate
o The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Pfizer

If you suspect COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) you have purchased may be counterfeit, contact Customer Service at +372 666 7500

For more information

Contact: +372 666 7500