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

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Additional Information About Pfizer BioNTech COVID-19 Vaccine

EUA Fact Sheet for Vaccination Providers 

 EUA Fact Sheet for Vaccination Providers - 12 years of age and older Dilute Before Use, Purple Cap EUA Fact Sheet for Vaccination Providers - 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Orange Cap

EUA Fact Sheet for Recipients and Caregivers 

 EUA Fact Sheet for Recipients and Caregivers - 12 years of age and older
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 EUA Fact Sheet for Recipients and Caregivers - 5 through 11 years of age
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Quick Reference on Available Formulations and PresentationsVaccine Formulation/Presentation Guide DOWNLOAD How to Prepare and dose DOWNLOAD
Checklist
 DOWNLOAD
Safety and StorageThermal Shipper Catalogue DOWNLOAD Dry Ice Replenishment Sheet DOWNLOAD Shipping and Handling Guidelines DOWNLOAD Product Safety Data Sheet
- Purple Cap Formulation VIEW Product Safety Data Sheet - Gray (Bivalent (Original and Omicron BA.4/BA.5)) and Orange Cap Formulations VIEW Dry Ice Safety Data Sheet
 VIEW
For more information ​​​​​​​

Medical Information
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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 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 - 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap
    •    EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Orange Cap

For Healthcare Professionals in Qatar only