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A new formulation of Pfizer/BioNTech COVID-19 Vaccine "12 years and older, Ready to use (Original/Omicron BA.4-5 Grey Cap and Package, Multi-dose vial) was approved FOR BOOSTER DOSES ONLY on 12/09/22 with procedure II/143.
Additional website content relevant to this new formulation will be available soon

Pfizer-BioNTech COVID-19 Vaccine Original/Omicron BA.4-5 (15/15 micrograms)/ dose dispersion for injection, for 12 years and older, Ready to use (Grey Cap and Package, Multi-dose Vial)

PP-CVV-BHR-0005

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 & Bahrain National Health Regulatory Authority (NHRA), 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.

Vaccine Formulations Guide

Children 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.

Pfizer-BioNTech COVID-19 Vaccine 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5) Gray Cap is only indicated as a single booster dose.

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, Bivalent, Original and Omicron BA.4/BA.5	5 through 11 years of age Dilute Before Use
Vial	Multi-dose Vial	Single- and 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	Original 15 mcg and Omicron BA.4/BA.5 15 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)	Single-dose Vial: 1 dose per vial Multi-dose Vial: 6 doses per via	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)	24 months (shelf life)^†	24 months (shelf life)^‡	24 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 single-dose vials or 10 multi-dose 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.

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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 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap, the vial label includes a gray 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 authorised 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

Manufactured for BioNTech
Manufacturing GmbH

Manufactured by Pfizer Inc.
Pfizer Gulf FZ-LLC Dubai Branch
Sheikh Zayed road, Al Moosa Tower 2
P.O.Box 29553, Dubai, UAE
Telephone: +971-4-3322286, Fax: +971-4-3320212
Registered Trademark

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

This site is intended for Healthcare Professionals in Bahrain. The products discussed in the site may have different product labeling in different countries. The information provided is for educational purposes only.