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 age6 months through 4 years of ageSafety & EfficacyResources
12 years of age and older Dilute Before Use​​​​​​​12 years of age and older Do Not Dilute12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5)

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Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older is indicated for primary series only and cannot be used for children 6 months through 11 years of age.
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Primary Series

Vaccine is administered as a primary series of 2 doses

FIRST DOSE


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​​​​​​​0.3 mL Intramuscular Injection

SECOND DOSE


​​​​​​​3 weeks after the first dose

​​​​​​​0.3 mL Intramuscular Injection

Third primary series dose for individuals with certain kinds of immunocompromise

A third primary series dose of the vaccine (0.3 mL) administered at least 28 days following the second dose is authorised for administration to individuals at least 12 years of age with certain kinds of immunocompromise.* 
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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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Dose preparation - 12 years of age and older Dilute Before Use, Purple Cap


Each vial MUST BE DILUTED before administering the vaccine.

Prior to Dilution

  • The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a purple cap contains a volume of 0.45 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 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. Do not add more than 1.8 mL of diluent

  • 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

  • After dilution, 1 vial contains 6 doses of 0.3 mL

​​​​​​​​​​​​​​​Dilution and Preparation Instructions for​​​​​​​ 12 years of age and older Dilute to use, Purple Cap 

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Pfizer‐BioNTech COVID‐19 Vaccine Vial with Purple Cap – VIAL VERIFICATION

  • Verify that the vial has a purple plastic cap. Some vials also may have a purple label border

THAWING PRIOR TO DILUTION

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

    • Allowing vial(s) to thaw in the refrigerator (2°C to 8°C). A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month

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

  • Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours


  • Before dilution invert 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 white to off-white 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 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle)

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

  • Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial


  • Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL of 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 an off-white suspension. Do not use if vaccine is discolored or contains particulate matter​​​​​


  • Record the date and time of dilution on the vaccine vial label 

  • Store between 2°C to 25°C

  • Discard any unused vaccine 6 hours after dilution

WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES

  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the vaccine preferentially using low dead-volume syringes and/or needles 

  • Each dose must contain 0.3 mL of vaccine

  • If the amount of vaccine remaining in a single vial cannot provide a full dose of 0.3 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 an off-white suspension. During the visual inspection: Administer the Pfizer‑BioNTech COVID-19 Vaccine intramuscularly.

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After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with purple caps contain 6 doses of 0.3 mL of vaccine. Low dead volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. Irrespective of the type of syringe and needle:​​​​​​​​​​​​​​
12 years of age and older Do Not Dilute 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5)
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