An updated formulation of COMIRNATY "12 years of age and older, Ready to use (monovalent Omicron XBB.1.5 Cap and Package, Single-dose or Multi-dose vial)" was approved on <Date> with procedure X/0000.
An updated formulation of COMIRNATY "5 to 11 years of age, Ready to use (monovalent Omicron XBB.1.5 Cap and Package, Single-dose or Multi-dose vial)" was approved on <Date> with procedure X/0000.
An updated formulation of COMIRNATY "6 months to 4 years of age, Dilute to use (monovalent Omicron XBB.1.5 Cap and Package, Multi-dose vial)" was approved on <date> with procedure X/0000.
COMIRNATY Omicron XBB.1.5 (30 micrograms raxtozinameran)/dose for dispersion for injection, for 12 years of age and older, Ready to use
(Omicron XBB.1.5 Cap and Package, Single-dose vial
COMIRNATY Omicron XBB.1.5 (30 micrograms raxtozinameran)/dose for dispersion for injection, for 12 years of age and older, Ready to use
(Omicron XBB.1.5 Cap and Package, Multi-dose vial)
COMIRNATY Omicron XBB.1.5 (10 micrograms raxtozinameran)/dose for dispersion for injection, for 5 to 11 years of age, Ready to use
(Omicron XBB.1.5 Cap and Package, Multi-dose vial)
COMIRNATY Omicron XBB.1.5 (10 micrograms raxtozinameran)/dose for dispersion for injection, for 5 to 11 years of age, Ready to use
(Omicron XBB.1.5 Cap and Package, Single-dose vial)
COMIRNATY Omicron XBB.1.5 (3 micrograms raxtozinameran)/dose for dispersion for injection, for 6 months to 4 years of age, Dilute to use
(Omicron XBB.1.5 Cap and Package, Multi-dose vial)
PP-CMR-SGP-0069\28AUG2023
A new formulation of COMIRNATY "6 months to 4 years of age, Dilute to use (Maroon Cap and Package, Multi-dose vial)" was approved on 28/09/22.
Additional website content relevant to this new formulation will be available on 7/11/22.
COMIRNATY 3 micrograms/dose concentrate for dispersion for injection for 6 months to 4 years of age, Dilute to use (Maroon Cap and Package, Multi-dose vial)
PP-CMR-SGP-0012/4OCt2022
This site is intended for Healthcare Professionals only.
Home
Report an Adverse Event
Product Information
Package Leaflet
Dilute to use, 12 years and older, Purple Cap Package Leaflet
12 years and older, Ready to use, Omicron XBB. 1.5, Grey Cap Package Leaflet
12 years and older, Ready to use, Original/Omicron BA.4-5, Grey Cap Package Leaflet
5 years to <12 years, Ready to use, Omicron XBB. 1.5, Blue Cap Package Leaflet
6 months to <5 years, Dilute to use, Omicron XBB. 1.5, Maroon Cap Package Leaflet
UK, English
Resources
A new formulation of COMIRNATY 12 years and older, Ready to use, Original/Omicron BA.4-5, Grey Cap has been authorised.
COMIRNATY Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID-19.
COMIRNATY 5 years old to <12 years old, Dilute to Use, Orange Cap has been authorised.
COMIRNATY 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged <5 years to <12 years.
COMIRNATY 6 months to <5 years old, Dilute to use, Maroon Cap has been authorised.
COMIRNATY 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to <5 years.
For details, please refer to the Product Information for the above formulations
COMIRNATY 12 years and older, Ready to use, Omicron XBB. 1.5, Grey Cap has been authorised.
COMIRNATY Omicron XBB. 1.5 (30 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19
caused by SARS-CoV-2, in individuals 12 years of age and older.
COMIRNATY 12 years and older, Ready to use, Original/Omicron BA.4-5, Grey Cap has been authorised.
COMIRNATY Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19
caused by SARS-CoV-2, in individuals 12 years of age and older
COMIRNATY 5 years old to <12 years old, Ready to Use, Omicron XBB. 1.5, Blue Cap has been authorised.
COMIRNATY Omicron XBB. 1.5 (10 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19
caused by SARS-CoV-2, in individuals 5 years old to <12 years old.
COMIRNATY 6 months to <5 years old, DIiute to use, Omicron XBB. 1.5, Maroon Cap has been authorised
COMIRNATY Omicron XBB. 1.5 (3 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19
caused by SARS-CoV-2, in individuals 6 months to <5 years old.
For details, please refer to the Product Information for the above formulations
Formulation |
Dilute to use, |
12 years and older, |
5 to 11 years old, |
|---|---|---|---|
Vial |
Multi-dose vial |
Multi-dose vial |
Multi-dose vial |
Vial Cap Color |
Purple |
Grey |
Orange |
Summary of Product Characteristics |
Summary of Product Characteristics |
Summary of Product Characteristics |
Summary of Product Characteristics |
Dosage |
30 mcg |
30 mcg |
10 mcg |
Dilution |
Dilution required |
Dilution NOT required |
Dilution required |
Amount of Diluent |
1.8 mL |
No dilution |
1.3 mL |
Vial Size |
2 mL |
2 mL |
2 mL |
Doses per Vial |
6 doses per vial |
6 doses per vial |
10 doses per vial |
Injection Volume per Dose |
0.3 mL |
0.3 mL |
0.2 mL |
Fill Volume per Vial |
0.45 mL |
2.25 mL |
1.3 mL |
Refrigeration Storage Time |
1 month |
10 weeks |
10 weeks |
Freezer Storage Time |
2 weeks within the 9-month shelf life |
DO NOT STORE |
DO NOT STORE |
ULT Freezer Storage Time |
9 months (shelf life) |
9 months (shelf life) |
9 months (shelf life) |
Room Temperature |
2 hours prior to dilution |
12 hours prior to first puncture |
12 hours prior to dilution |
After First Puncture or Dilution |
Discard 6 hours after dilution |
Discard 12 hours after first puncture |
Discard 12 hours |
Package Size |
195 vials |
10 vials |
10 vials |
COMIRNATY Omicron XBB.1.5 COVID-19 mRNA Vaccine (nucleoside modified) is indicated 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)
COMIRNATY Original/Omicron BA.4-5 is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older [(15/15 micrograms)/dose]
The use of this vaccine should be in accordance with official recommendations.
The nucleoside-modified messenger RNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the non replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.
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
COMIRNATY is only administered intramuscularly by government-authorized healthcare professionals
COMIRNATY is not taken orally and is not available in a capsule or tablet form
with a grey cap and border for 12 years and older, Ready to use, Omicron XBB.1.5
with a grey cap and border for 12 years and older, Ready to use, Original/Omicron BA.4-5
with a blue cap and border for 5 to 11 years old, Ready to use, Omicron XBB.1.5
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
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 us here.
BioNTech Pharmaceuticals Asia Pacific Pte Ltd
100 Tras Street #16-01
100AM, Singapore 079027
Pfizer Private Limited
80 Pasir Panjang Road, #16-81/82
Mapletree Business City, Singapore 117372
COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified), which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.
©2022 Pfizer Inc. All rights reserved.
PP-CMR-SGP-0058/12JULY2023
Updates to Product Information include the addition of these new formulations:
12 years and older, Ready to use, Omicron XBB.1.5, Grey Cap formulation,
12 years and older, Ready to use, Original/Omicron BA. 4-5, Grey Cap formulation,
5 to 11 years old, Ready to use, Omicron XBB.1.5, Blue Cap formulation, and
6 months to 4 years old, Dilute to use, Omicron XBB.1.5, Maroon Cap formulation.
Information about myocarditis and pericarditis has also been updated for all formulations.
For details, please refer to Product Information for each formulation.
For healthcare professionals only
The information contained on this site is reserved exclusively for healthcare professionals residing in Singapore.
I confirm that I am a healthcare professional residing in Singapore.
I accept and agree to the Terms of Use*
Not a Healthcare Professional in Singapore? This website is not intended for patients or for members of the general public.