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
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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)
PP-CMR-GLB-0188

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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 for children 5 through 11 years of age cannot be used for individuals 6 months through 4 years of age or individuals 12 years of age and older.
 

Primary Series

Vaccine is administered as a primary series of 2 doses

FIRST DOSE



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​​​​​​​​​​​​​​​​0.2 mL Intramuscular Injection

SECOND DOSE

3 weeks after the first dose
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0.2 mL Intramuscular ​​​​​​Injection
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Third primary series dose for individuals with certain kinds of immunocompromise

A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) at least 28 days following the second dose is authorised for administration to individuals 5 through 11 years of age with certain kinds of immunocompromise.*

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Booster Dose

SINGLE BOOSTER DOSE
 

At least 2 months after primary series
 

0.2 mL Intramuscular ​​​​​​Injection

A single Pfizer-BioNTech COVID-19 Vaccine booster dose supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) may be administered, after dilution, at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.
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*Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
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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. 

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Dose Preparation - 5 through 11 years of age Dilute Before Use, Orange Cap 

Each vial MUST BE DILUTED before administering the vaccine.


Prior to Dilution
  • The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with an orange cap and a label with an orange border contains a volume of 1.3 mL and is supplied as a frozen suspension that does not contain 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 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

  • 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, Orange Cap


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

  • Verify that the vial of Pfizer‑BioNTech COVID‑19 Vaccine has an orange plastic cap and a label with an orange border and states “Age 5y to < 12y”

THAWING PRIOR TO DILUTION
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Thaw vial(s) of the vaccine 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, and thawed vials can be stored in the refrigerator for up to 10 weeks

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

  • 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

  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of the Pfizer-BioNTech COVID-19 Vaccine preferentially using a low dead-volume syringe and/or needle

  • Each dose must contain 0.2 mL of vaccine

  • 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

  • Administer immediately

Administration

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be a white to off-white suspension. During the visual inspection,

Administer the vaccine intramuscularly.​​​​​​​

After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with orange caps and labels with orange borders contain 10 doses of 0.2 mL of vaccine. Low dead volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:

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