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Expiry Date Information
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EUA Fact Sheets for Vaccination Providers
EUA Fact Sheets for Recipients
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The expiry date of the product is 18 months. Within the 18 months are the following storage options:
PREFERRED
Can be stored up to
at this temperature within the 18-month shelf life
Can be stored up to
at this temperature within the 18-month shelf life
Can be stored up to
at this temperature within the 18-month shelf life
Frozen Vials Prior to Use
Cartons of Pfizer‑BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal shipping containers with dry ice. Once received, remove the vial cartons immediately from the thermal shipping container and preferably store in an ultra-low-temperature freezer between -90°C to -60°C until the expiry date printed on the label. The expiry date information in this section supersedes the storage conditions printed on the vial cartons.
Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained.
| Printed Expiry Date | Updated Expiry Date |
|---|---|
| 12/2021 | 31-Dec-2022 |
| 01/2022 | 31-Jan-2023 |
| 02/2022 | 28-Feb-2023 |
| 03/2022 | 31-Mar-2023 |
| 06/2022 | 31-Mar-2023 |
| 07/2022 | 30-Apr-2023 |
| 08/2022 | 31-May-2023 |
| 09/2022 | 30-Jun-2023 |
| 10/2022 | 31-Jul-2023 |
| 11/2022 | 31-Aug-2023 |
| 12/2022 | 30-Sep-2023 |
Regardless of storage condition, the vaccine should not be used past the 18-month expiry (6 months printed on the vial plus additional 12 months for the expiry dates December 2021 through March 2022. 9 months printed on the vial plus additional 9 months for the expiry dates June 2022 through December 2022).
If not stored between -90°C to -60°C, vials may be stored at -25°C to -15°C for up to 2 weeks. Vials must be kept frozen and protected from light until ready to use. Vials stored at -25°C to -15°C for up to 2 weeks may be returned one time to the recommended storage condition of -90°C to -60°C. Total cumulative time the vials are stored at -25°C to -15°C should be tracked and should not exceed 2 weeks
If an ultra-low-temperature freezer is not available, the thermal shipping container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the dry ice replenishment guidelines packed in the original thermal shipping container, or on the Resources page of this site for instructions regarding the use of the thermal shipping container for temporary storage. The thermal shipping container maintains a temperature range of -90°C to -60°C. Storage of the vials between -96°C to -60°C is not considered an excursion from the recommended storage condition
Transportation of Frozen Vials
If local redistribution is needed and full vial cartons containing vials cannot be transported at ‐90°C to ‐60°C, vials may be transported at -25°C to ‐15°C
Any hours used for storage or transport at ‐25°C to ‐15°C count against the 2‐week limit for storage at ‐25°C to ‐15°C
Frozen vials transported at ‐25°C to ‐15°C may be returned one time to the recommended storage condition of ‐90°C to ‐60°C
Thaw and then store undiluted vials in the refrigerator (2°C to 8°C) for up to 1 month. A carton of 195 vials may take up to 3 hours to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time
For immediate use, thaw undiluted vials at room temperature (up to 25°C) for 30 minutes. Thawed vials can be handled in room light conditions. Vials must reach room temperature before dilution
Undiluted vials may be stored at room temperature for no more than 2 hours
Transportation of Thawed Vials
Vials After Dilution
After dilution, store vials between 2°C to 25°C and use within 6 hours from the time of dilution
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light
Any vaccine remaining in vials must be discarded after 6 hours
Do not refreeze
Safely dispose
Discard vaccine vials that:
Have been fully discharged and used to administer vaccinations
Are more than 6 hours from time of dilution
Transferring Between Environments - 12 years of age and older Dilute Before Use, Purple Cap
Storage and Handling
Do not open vial cartons until there is a need to remove vials for transfer, thawing, or use
Upon delivery:
Inspect the thermal shipping container to confirm that ordered vial cartons were received
Do not stack or place anything on top of the thermal shipping container
Vial carton and vial handling between storage environments
When possible, to protect the vials that will remain in the freezer, keep the vial carton in the frozen environment while transferring the vials to a secondary container. If vial cartons must be removed, limit to the transfer times indicated below. Once an individual vial is removed from a vial carton at room temperature, it should not be returned to frozen storage and should be thawed for use. Do not refreeze thawed vials.
Transferring vial cartons between storage environments
Unopened vial cartons containing 195 vial packs removed from ultra-low temperature (ULT) freezer (-90°C to -60°C) or thermal shipping container may be at room temperatures up to 25°C for 5 minutes
Unopened vial cartons containing 195 vial packs removed from freezer (-25°C to -15°C) may be at room temperature up to 25°C for 3 minutes
Opened vial cartons containing 195 vial packs removed from ultra-low temperature (ULT) freezer (-90°C to -60°C) or thermal shipping container may be at room temperatures up to 25°C for 3 minutes
Opened vial cartons containing 195 vial packs removed from freezer (-25°C to -15°C) may be at room temperature up to 25°C for 1 minute
Contact Pfizermedicalinformation.com
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