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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)
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HomeShelf Life & StorageDosing & Administration12 years of age and older5 through 11 years of age6 months through 4 years of ageSafety & EfficacyResources
5 through 11 years of age Dilute Before Use5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5)

Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 5 through 11 years of age cannot be used for individuals 12 years of age and older. 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.
 

Booster Dose

EITHER

Individuals 5 through 11 years of age

SINGLE BOOSTER DOSE


At least 2 months after completion of primary vaccination with any authorised or approved 
COVID-19 vaccine



​​0.2 mL Intramuscular Injection

OR

Individuals 5 through 11 years of age

SINGLE BOOSTER DOSE


At least 2 months after receipt of the most recent booster dose with any authorised or approved monovalent* COVID-19 vaccine



​​0.2 mL Intramuscular Injection

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


Pfizer-BioNTech COVID-19 Vaccine that is supplied in vials with purple, gray, or maroon caps and Pfizer-BioNTech COVID-19 Vaccine, Bivalent that is supplied in vials with gray caps should not be used for individuals 5 through 11 years of age because of the potential for vaccine administration errors, including dosing errors. 

​​​​​​​​​​​​​​

 



 


Dose Preparation - 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), Orange Cap 

Each vial MUST BE DILUTED before administering the vaccine.


Prior to Dilution

  • The Pfizer-BioNTech COVID-19 Vaccine, Bivalent vials contain a frozen suspension that does not contain a preservative. Each vial must be thawed before dilution

  • Vials may be thawed in the refrigerator (2°C to 8°C) or at room temperature (up to 25°C)

  • Refer to thawing and preparation instructions in the panels below

Dilution

  • Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine, Bivalent

  • ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Do not add more than 1.3 mL of diluent

  • After dilution, 1 vial contains 10 doses of 0.2 mL


Dilution and Preparation instructions for 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), Orange Cap


 

Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial with Orange Cap and Label with Orange Border – VIAL VERIFICATION

  • Verify that the vial of Pfizer‑BioNTech COVID-19 Vaccine, Bivalent: 

    • has an orange cap and a label with an orange border,

    • states Pfizer‑BioNTech COVID‑19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), and

    • states “Age 5y to < 12y.”

THAWING PRIOR TO DILUTION​​​​​

  • Thaw vial(s) of Pfizer‑BioNTech COVID-19 Vaccine, Bivalent before use either by:

    • Allowing vial(s) to thaw in the refrigerator (2°C to 8°C)

      • A carton of 10 vials may take up to 4 hours to thaw

    • Allowing vial(s) to sit at room temperature (up to 25°C) for 30 minutes

  • Thawed vials can be stored in the refrigerator (2°C to 8°C) for up to 10 weeks prior to use

  • Thawed vials may be stored at room temperature (up to 25°C) for up to 12 hours prior to use


  • Before dilution, mix by inverting vaccine vial gently 10 times
      
  • Do not shake

  • Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain opaque amorphous particles

  • Do not use if liquid is discolored or if other particles are observed

DILUTION

  • Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent

  • Using aseptic technique, withdraw 1.3 mL of diluent into a transfer syringe (21‑gauge or narrower needle)

  • Cleanse the vaccine vial stopper with a single‑use antiseptic swab

  • Add 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial


  • Equalize vial pressure before removing the needle from the vial by withdrawing 1.3 mL air into the empty diluent syringe


  • Gently invert the vial containing the vaccine 10 times to mix 

  • Do not shake

  • Inspect the vaccine in the vial

  • The vaccine will be a white to off-white suspension. Do not use if vaccine is discolored or contains particulate matter 

 

  • Record the date and time of dilution on the vial label 
     
  • Store between 2°C to 25°C
     
  • Discard any unused vaccine 12 hours after dilution

WITHDRAWAL OF INDIVIDUAL 0.2 mL DOSES

  • Withdraw 0.2 mL of the Pfizer‑BioNTech COVID‑19 Vaccine, Bivalent preferentially using low dead‑volume syringes and/or needles. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial

  • Administer immediately

  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume

Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine will be a white to off-white suspension. Do not administer if vaccine is discolored or contains particulate matter.
 
After withdrawing a single dose of 0.2 mL of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, administer immediately.

For more information ​​​​​​​

Contact  Pfizermedicalinformation.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 22 December 2022


Updated shelf life for all formulations. Please see the Shelf Life & Storage page of this website for more information.

Available data supporting transportation of thawed vials increased up to 48 hours.


Click below to view:
    •    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, Gray 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 Vaccination Providers - 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), Orange Cap
    •    EUA Fact Sheet for Vaccination Providers - 6 months through 4 years of age Dilute Before Use, Maroon Cap
 

For healthcare professionals only