Storage Options - The 12 years of age and older Do Not Dilute, the 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), the 5 through 11 years of age Dilute Before Use, the 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), and the 6 months through 4 years of age Dilute Before Use formulations

Vial Storage Prior to Use

• Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with gray caps and labels with gray borders, multiple dose vials with orange caps and labels with orange borders, or multiple dose vials with maroon caps and labels with maroon borders may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent single dose and multiple dose vials with gray caps and labels with gray borders, or cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials with orange caps and labels with orange borders may arrive frozen at ultra-cold conditions in thermal containers with dry ice.

• Once received, frozen vials may be immediately transferred to the refrigerator 2°C to 8°C, thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 2 hours to thaw at this temperature for maroon cap vials, up to 4 hours to thaw at this temperature for orange cap vials, and up to 6 hours for gray cap vials. For cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent vials with gray caps and labels with gray borders, a carton of 10 single dose vials may take up to 2 hours to thaw at this temperature and a carton of 10 multiple dose vials may take up to 6 hours to thaw at this temperature. For cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent vials with orange caps and labels with orange borders, a carton of 10 single dose vials may take up to 4 hours to thaw at this temperature.

• Alternatively, frozen vials may be stored in an ultra-low-temperature freezer at -90°C to -60°C for up to 18 months from the date of manufacture.  Do not store vials at -25°C to -15°C. Once vials are thawed, they should not be refrozen.

• If cartons of Pfizer‑BioNTech COVID-19 Vaccine multiple dose vials with gray caps and labels with gray borders, multiple dose vials with orange caps and labels with orange borders, or multiple dose vials with maroon caps and labels with maroon borders are received at 2°C to 8°C, they should be stored at 2°C to 8°C. If cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent single dose and multiple dose vials with gray caps and labels with gray borders are received at 2°C to 8°C, they should be stored at 2°C to 8°C. If cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials with orange caps and labels with orange borders are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 

• Regardless of storage condition, the vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 18 months from the date of the manufacture are shown below for gray cap vials.

  Printed Manufacturing Date	18-Month Expiry Date
  10/2021	31-Mar-2023
  11/2021	30-Apr-2023
  12/2021	31-May-2023
  01/2022	30-June-2023
  02/2022	31-Jul-2023

• Regardless of storage condition, the vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 18 months from the date of the manufacture are shown below for orange cap vials.

  Printed Manufacturing Date	18-Month Expiry Date
  10/2021	31-Mar-2023
  11/2021	30-Apr-2023
  12/2021	31-May-2023
  01/2022	30-June-2023
  02/2022	31-Jul-2023

• Regardless of storage condition, the vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 18 months from the date of the manufacture are shown below for maroon cap vials.

  Printed Manufacturing Date	18-Month Expiry Date
  01/2022	30-Jun-2023
  02/2022	31-Jul-2023
  03/2022	31-Aug-2023
  04/2022	30-Sep-2023
  05/2022	31-Oct-2023
  06/2022	30-Nov-2023

• Regardless of storage condition, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (vials with gray caps and labels with gray borders or vials with orange caps and labels with orange borders) should not be used after 18 months from the date of manufacture printed on the vial and cartons.

Vial Storage During Use

• If not previously thawed at 2°C to 8°C, allow vials to thaw at room temperature up to 25°C for 30 minutes.

• Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with gray caps and labels with gray borders may be stored at room temperature 8°C to 25°C for a total of 12 hours prior to first puncture.

• For 12 years of age and older Do Not Dilute, Gray Cap: DO NOT DILUTE PRIOR TO USE. After first puncture, the vial should be held between 2°C to 25°C. Vials should be discarded 12 hours after first puncture.

• Pfizer-BioNTech COVID-19 Vaccine, Bivalent single dose and multiple dose vials with gray caps and labels with gray borders may be stored at room temperature 8°C to 25°C for a total of 12 hours prior to first puncture.

• For 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap: DO NOT DILUTE PRIOR TO USE. After first puncture, the multiple dose vials should be held between 2°C to 25°C. Multiple dose vials should be discarded 12 hours after first puncture.

• Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature 8°C to 25°C for a total of 12 hours prior to dilution.

• For 5 through 11 years of age Dilute Before Use, Orange Cap: After dilution, the vial should be held between 2°C to 25°C. Vials should be discarded 12 hours after dilution.

• Pfizer-BioNTech COVID-19 Vaccine, Bivalent multiple dose vials with orange caps and labels with orange borders may be stored at room temperature 8°C to 25°C for a total of 12 hours prior to dilution.

• For 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), Orange Cap: After dilution, the vial should be held between 2°C to 25°C. Vials should be discarded 12 hours after dilution.

• Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with maroon caps and labels with maroon borders may be stored at room temperature 8°C to 25°C for a total of 12 hours prior to dilution.

• For 6 months through 4 years of age Dilute Before Use, Maroon Cap: After dilution, the vial should be held between 2°C to 25°C. Vials should be discarded 12 hours after dilution.

Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information immediately above supersedes the number of hours printed on vial labels and cartons.

Transportation of Vials

If local redistribution is needed, vials may be transported at -90°C to -60°C or at 2°C to 8°C.