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 Use12 years of age and older Do Not Dilute12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5)

Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older is indicated for a booster dose only and cannot be used for children 6 months through 11 years of age. A different presentation of Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in multiple dose vials with orange caps and labels with orange borders is available for use in individuals 5 through 11 years of age.
​​

Booster Dose

EITHER

Individuals 12 Years of Age and Older

SINGLE BOOSTER DOSE

 

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


0.3 mL Intramuscular Injection

​​
OR

Individuals 12 Years of Age and Older

SINGLE BOOSTER DOSE

 

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


0.3 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.

Dose Preparation  - 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap

 

DO NOT DILUTE
  • Pfizer‑BioNTech COVID-19 Vaccine, Bivalent vials contain a frozen suspension without preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use
  • 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

​​​​​​​Preparation instructions for​​​​​​​ 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap
 

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

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

    • has a gray cap and a label with a gray border

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

THAWING PRIOR TO USE

  • 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 single dose vials may take up to 2 hours to thaw

      • A carton of 10 multiple dose vials may take up to 6 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 use, mix by inverting vaccine vial gently 10 times 

  • Do not shake
     
  • Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles

  • After mixing, the vaccine should appear as a white to off-white suspension with no visible particles

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

PREPARATION OF INDIVIDUAL 0.3 mL DOSES

Single Dose Vial

  • Withdraw a single 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent

  • Administer immediately

  • Discard vial and any excess volume

Multiple Dose Vial 

  • Multiple dose vials contain 6 doses of 0.3 mL each

  • Withdraw 0.3 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 6 doses from a single vial

  • Administer immediately

  • If the amount of vaccine remaining in a multiple dose vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume

Multiple Dose Vial - Record Date and Time of First Puncture

  • Record the date and time of first vial puncture on the Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vial label
     
  • Store between 2°C to 25°C 
     
  • Discard any unused vaccine 12 hours after first puncture

​​​​​​​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 0.3 mL dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, administer immediately.

 

12 years of age and older Dilute Before Use 12 years of age and older Do Not Dilute 
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