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

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HomeShelf Life & StorageDosing & Administration12 years of age and older5 through 11 years of ageSafety & EfficacyResources

Pfizer-BioNTech COVID-19 Vaccine Authorised for Emergency Use: Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorised by FDA & Kuwait Drug and Food Control – Ministry of Health, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Authorised for Emergency Use: Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorised by FDA, under an EUA to prevent COVID-19 in individuals 5 years of age and older. The emergency uses are only authorised for the duration of the declaration that circumstances exist justifying the authorisation of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorisation revoked sooner.


 

12 years of age and older
Dosing & Administration
Shelf Life & Storage
5 through 11 years of age
Dosing & Administration
Shelf Life & Storage
Vaccine Formulations GuideChildren ages 5 through 11 years old should only be vaccinated with the 5 through 11 years of age Dilute Before Use Orange Cap presentation. No other vaccine presentation should be used for children 5 through 11 years old because of the potential for vaccine administration errors, including dosing errors. For children who will turn 12 between their first and second dose, consult the EUA Fact Sheets for Vaccination Providers.

The formulation of Pfizer-BioNTech COVID-19 Vaccine, 12 years of age and older Dilute Before Use Purple Cap, when prepared according to their respective instructions for use, is indicated for primary series only.

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

Formulation

12 years of age and older
​​​​​​​ Dilute Before Use

12 years of age and older
​​​​​​​Do Not Dilute

5 through 11 years of age
​​​​​​​Dilute Before Use

Vial

Multi-dose Vial

Multi-dose Vial

Multi-dose Vial

Vial Cap Color

Purple

Gray

Orange

EUA Fact Sheet for Vaccination Providers

EUA Fact Sheet for Vaccination Providers
 

EUA Fact Sheet for Vaccination Providers
 

EUA Fact Sheet for Vaccination Providers
 

Dosage

30 mcg

30 mcg

10 mcg

Injection Volume per Dose

0.3 mL

0.3 mL

0.2 mL

Dilution

Dilution required

NO DILUTION

Dilution required

Amount of Diluent
Needed per Vial*

1.8 mL

NO DILUTION

1.3 mL

Doses per Vial

6 doses per vial
(after dilution)

6 doses per vial

10 doses per vial
(after dilution)

Vial Size

2 mL

2 mL

2 mL

Fill Volume per Vial

0.45 mL

2.25 mL

1.3 mL

Storage Conditions

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

12 months (shelf life)

9 months (shelf life)

12 months (shelf life)

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

2 weeks

DO NOT STORE

DO NOT STORE

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

1 month

10 weeks

10 weeks

Room Temperature
​​​​​​​(8°C to 25°C)

2 hours prior to dilution
(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 25°C)

Discard after 6 hours

Discard after 12 hours

Discard after 12 hours

Package Size

195 vials

10 vials

10 vials

*Diluent: sterile 0.9% Sodium Chloride Injection, USP. Bacteriostatic saline or other diluents must NOT be used.
aRegardless of storage condition, vaccine should not be used past the 15-month expiry (6 months printed on the vial plus additional 9 months for the expiry dates December 2021 through March 2022. 6 months printed on the vial plus additional 6 months for the expiry dates June 2022 through December 2022. All vials with expiry date beyond December 2022 will already reflect the 15-month shelf life). 
bRegardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons.

DOWNLOAD THIS GUIDE
Pfizer-BioNTech COVID-19 Vaccine
Authorised Use 

Pfizer-BioNTech COVID-19 Vaccine is authorised for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. 

Interchangeability (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the EUA-authorised Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns. 
Because of the potential for vaccine administration errors, including dosing errors, vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 
Authorised Use

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorised for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older.

Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine
  • Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccine, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate vaccines to protect patients from products that might be dangerous and lead to serious and life-threatening harm
    • The vaccine is only administered intramuscularly by a healthcare professional
    • The vaccine is not taken orally and is not available in a capsule or tablet form
  • Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and are dispensed in a vial as follows:
    • For 12 years of age and older Dilute Before Use, Purple Cap, two versions of the vial label are in current circulation - with or without a purple border
    • For 5 through 11 years of age Dilute Before Use, Orange Cap, the vial label includes an orange border
  • Ensure the safety of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use. To prevent counterfeits, discard vaccine vials in sharps containers and empty vial cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through government-authorised vaccination centers – such as doctor’s offices, authorised pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccine can only be administered by licensed healthcare professionals, or other individuals that are approved vaccinators, at government-authorised vaccination sites. Individual doses are not for sale

If you suspect the Vaccine you have purchased may be counterfeit, contact us at 1-800-438-1985 or
visit https://www.pfizer.com/products/product-contact-information.

For more information ​​​​​​​

Medical Information
Visit PfizerMedicalInformationgulf.com

Contact

EUA Fact Sheet Updates

Please be aware that Pfizer-BioNTech COVID-19 Vaccine is now available in 6 formulations. For additional information on differences across age groups and formulations please see Vaccine Formulations Guide on the home page of this website.


Label Update: Effective 31 AUG 2022

Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which is supplied in a multiple dose vial with an orange cap and a label with an orange border, should not be used in individuals 12 years of age and older.†

Updated shelf life for 12 years of age and older Dilute Before Use, Purple Cap formulation. Please see the Shelf Life & Storage page of this website for more information. 

Important Safety Information has been updated. Please see the Safety & Efficacy page of this website for details. 

*Monovalent refers to any authorised or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.

†A different presentation of Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in a single dose and multiple dose vials with gray caps and labels with gray borders is available for use in individuals 12 years of age and older.

Click below to view:
    •    EUA Fact Sheet for Vaccination Providers
- 12 year of age and older Dilute Before Use, Purple Cap
    •    EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Orange Cap

For Healthcare Professionals in Kuwait only