A new formulation of the COMIRNATY booster "12 years of age and older, Ready
to use (Original/Omicron BA.1 Cap and Package, Multi-dose vial)" was approved
on DD/MM/YY with procedure X/0000.Additional website content relevant to this
new formulation will be available on DD/MM/YY.

COMIRNATY Original/Omicron BA.1 15/15 micrograms/per dose for dispersion
for injection, for 12 years of age and older, Ready to use (Original/Omicron BA.1
Cap and Package, Multi-dose vial)
PP-CMR-GLB-0188

This site is intended for Healthcare Professionals within the scope of COVAX facility.

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Global information about
Regulatory approval has been granted in many countries worldwide:
- for the product COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years (10 micrograms/dose), and individuals 12 years of age and older (30 micrograms/dose)
- for the products COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5 COVID-19 mRNA Vaccines (nucleoside modified) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older [(15/15 micrograms)/dose] who have previously received at least a primary vaccination course against COVID-19

In addition to the regulatory approvals in several countries, the World Health Organization (WHO) has issued an Emergency Use Listing for the product COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) and for the products COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5. Under the WHO Emergency Use Listing, COMIRNATY COVID‑19 mRNA Vaccine (nucleoside modified) may also be distributed with the packaging with the name ‘Pfizer‑BioNTech COVID‑19 Vaccine’.
Pfizer Medical Information  
Expiry Date Information 
Report a COMIRNATY COVID‑19 mRNA Vaccine (nucleoside
modified) Adverse Event

 ​​​©2023 Pfizer Inc. All rights reserved. September 2023. PP-CMR-GLB-0524​​​

 Vaccine Formulations GuideRefer to the information outlined below to understand the differences across age groups and formulations

Formulation

30 micrograms/dose concentrate for dispersion for injection
​​​​​​​
Dilute to use,
12 years and older

30 micrograms/dose dispersion for injection

12 years and older,
​​​​​​​Ready to use​​​​​​​

Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection

12 years and older,
Ready to use

Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection

12 years and older,
Ready to use​​​​​​​

10 micrograms/dose concentrate for dispersion for injection

5 to 11 years old, 
Dilute to use

10 micrograms/dose concentrate for dispersion for injection

5 to 11 years old, 
Dilute to use

Vial

Multi-dose vial

Multi-dose vial

Multi-dose vial

Multi-dose vial

Multi-dose vial

Multi-dose vial

Vial Cap Color

Purple

Grey

Grey

Grey

Orange

Orange

WHO Product Information

WHO Product Information for

 Dilute to use, 12 years and older 

WHO Product Information for

 12 years and older, Do not dilute 

WHO Product Information for

 12 years and older, Do not dilute, Original/Omicron BA.1

WHO Product Information for

 12 years and older, Do not dilute, Original/Omicron BA.4-5

​​​​​​
WHO Product Information for

 5 to 11 years old, Dilute to use 
​​​​​​​                                                                              ​​​​

​​​​​​
WHO Product Information for

 5 to 11 years old, Dilute to use 
​​​​​​​                                                                              ​​​​

Dosage

30 mcg

30 mcg

15 mcg of tozinameran and 15 mcg of riltozinameran

15 mcg of tozinameran and 15 mcg of famtozinameran

10 mcg

10 mcg

Injection Volume per Dose

0.3 mL

0.3 mL

0.3 mL

0.3 mL

0.2 mL

0.2 mL

Dilution

Dilution required

NO DILUTION

NO DILUTION

NO DILUTION

Dilution required   

Dilution required   

Amount of Diluent Needed per Vial*

1.8 mL

NO DILUTION

NO DILUTION

NO DILUTION

1.3 mL

1.3 mL

Doses per Vial

6 doses per vial
(after dilution)

6 doses per vial

6 doses per vial

6 doses per vial

10 doses per vial
(after dilution)

10 doses per vial
(after dilution)

Fill Volume per Vial

0.45 mL

2.25 mL

2.25 mL

2.25 mL

1.3 mL

1.3 mL


STORAGE CONDITIONS**

Ultra-Low-Temperature (ULT) Freezer
​​​​​​​(-90 °C to -60 °C)

2 years (shelf life) a

2 years (shelf life) a

2 years (shelf life) a

2 years (shelf life) a

2 years (shelf life) a

2 years (shelf life) a

Freezer Storage Time
​​​​​​​(-25 °C to -15 °C)

2 weeks

DO NOT STORE

DO NOT STORE

DO NOT STORE

DO NOT STORE

DO NOT STORE

Refrigeration Storage Time
(2 °C to 8 °C)

1 month

10 weeks

10 weeks

10 weeks

10 weeks

10 weeks

After First Puncture
​​​​​​​(2 °C to 8 °C)

Discard after 6 hours

Discard after 6 hours

Discard after 6 hours

Discard after 6 hours

Discard after 6 hours

Discard after 6 hours

* Diluent: sterile sodium chloride 9 mg/mL (0.9%) solution for injection. Bacteriostatic saline or other diluents must NOT be used.​​​​
** The storage and handling conditions printed on the vial or carton labels may differ from those in the WHO product information and the above table. In these circumstances, the conditions in the WHO product information should be followed.
aPlease visit Expiry Date Information page for important details on shelf life

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.

Privacy: The terms available at pfizer.com/privacy shall apply. These terms may differ from those applicable in your country. Please check your local Pfizer website for the privacy terms specific to your country.​​​

 ​​​©2023 Pfizer Inc. All rights reserved. September 2023. PP-CMR-GLB-0524​​​

FOR HEALTHCARE PROFESSIONALS ONLY

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