Do Not Dilute
Dilute Before Use
STORAGE - GRAY CAP
12 years of age and older, DO NOT DILUTE (Gray Cap) presentation may be stored in a refrigerator for up to 10 weeks4
12 years of age and older, DO NOT DILUTE (Gray Cap) presentation of the vaccine has a gray cap and gray label border and must not be diluted.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Vial storage prior to use - Gray Cap4
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Cartons of the vaccine may arrive at ultra-cold conditions in thermal containers with dry ice
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Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed, and stored for up to 10 weeks
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The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer
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Alternatively, frozen vials may be stored in an ultra-low-temperature freezer at -90°C to -60°C (-130°F to -76°F). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed they should not be refrozen
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If vials 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
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After the first dose is withdrawn, the vial should be stored at 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after the first puncture
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Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in the Fact Sheet supersedes the number of hours printed on vial labels and cartons
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Regardless of storage condition, gray cap vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 12 months from the date of the manufacture are shown below. Expiry Information may be updated periodically, click here for updated expiry information
Pfizer-BioNTech COVID-19 Vaccine - labeled vials
Printed Manufacturing Date
07/2021
08/2021
09/2021
10/2021
11/2021
12/2021
01/2022
02/2022
12-Month Expiry Date
30-Jun-2022
31-Jul-2022
31-Aug-2022
30-Sep-2022
31-Oct-2022
30-Nov-2022
31-Dec-2022
31-Jan-2023
COMIRNATY® (COVID-19 Vaccine, mRNA) - labeled vials
Printed Expiry Date
09/2022
10/2022
Updated Expiry Date
31-Dec-2022
31-Jan-2023
Transportation of vials - Gray Cap4
If local redistribution is needed, vials may be transported at -90°C to -60°C (-130°F to -76°F) or 2°C to 8°C (35°F to 46°F). Thawed vials should never be refrozen.
Single-Use and Medium Thermal Shipping Containers7
The vaccine is provided in a Single-Use or Medium Thermal Shipping Container.
Single-Use Thermal Shipping Container
Ensure the label on the container states Single-Use ULT.
This container may NOT be used as temporary storage.
Please review the Shipping and Handling Guidelines for Single-Use Shipping Containers.
After use, dispose of the container at your facility. The Temperature-Monitoring Device must be returned to the supplier in the
Click here to learn more about returning the thermal shipping container or temperature-monitoring device.
Medium Thermal Shipping Container
Ensure the label on the container states Medium ULT.
The vaccine is provided in a Medium Thermal Shipping Container. The thermal shipping container may be used as temporary storage for up to 30 days from delivery. Please refer to the storage and temperature guidelines available on this page.
If an ultra-low-temperature freezer is not available for storage, the thermal shipping container in which the vaccine arrives may be used as temporary storage for up to 30 days from delivery, when consistently
re-filled with dry ice. Refer to the Dry Ice Replenishment Sheet. The thermal shipping container maintains
a temperature range of -90°C to -60°C (-130°F to -76°F). Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an excursion from the recommended storage condition.3 Refer
to return instructions for details.
Please review the Shipping and Handling Guidelines for Medium Thermal Shipping Containers.
Click here to learn more about returning the thermal shipping container or temperature-monitoring device.
Time and temperature considerations - Gray Cap7
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Do not open vial cartons until there is a need to remove vials for transfer, thawing, or use
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Upon delivery:
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Inspect the thermal shipping container to confirm that ordered vial cartons were received
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Do not stack or place anything on top of the thermal shipping container
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Vial carton and vial handling between storage environments:
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.
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Dry Ice can be hazardous. Take necessary precautions by reviewing the Dry Ice Safety Data Sheet, and consult with your Occupational Health Department. Ensure there is proper ventilation and wear safety goggles or safety glasses with side shields and waterproof insulated gloves when handling dry ice
Safely dispose - Gray Cap4,7
Discard vaccine vials that:
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Have had the maximum number of complete doses extracted to administer vaccinations
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Are more than 12 hours after the first puncture
Discard vaccine vials in a sharps container as medical waste to ensure they are permanently destroyed. Discard vial cartons as medical waste so they cannot be reused.
Safety Resources - Gray Cap
Storage, Shipping, and Handling Resources - Gray Cap
STORAGE - PURPLE CAP
Options for storage of the 12 years of age and older, DILUTE BEFORE USE (Purple Cap) presentation3
The vaccine should be preferably stored in an ultra-low-temperature (ULT) freezer between -90°C to -60°C (-130°F to -76°F) until the expiry date printed on the label. Alternatively, vials may be stored or transported frozen at temperatures
of -25°C to -15°C (-13°F to 5°F) for up to 2 weeks and may be returned one time to ultra-low-temperature storage. Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should not exceed 2 weeks. Vials may also be
stored in a refrigerator
*Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of October 2021 through December 2022 (printed on 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.‡ Expiry information may be updated periodically, click here for updated expiry information.
Printed Expiry Date
12/2021
01/2022
02/2022
03/2022
06/2022
07/2022
08/2022
09/2022
10/2022
11/2022
12/2022
Updated Expiry Date
30-Jun-2022
31-Jul-2022
31-Aug-2022
30-Sep-2022
30-Sep-2022
31-Oct-2022
30-Nov-2022
31-Dec-2022
31-Jan-2023
28-Feb-2023
31-Mar-2023
†Refer to the dry ice replenishment guidelines packed in the original thermal shipping container for instructions regarding the use of the thermal shipping container for temporary storage or download here.
‡Regardless of storage condition, purple cap vaccine should not be used past the 12-month expiry. For vials with expiry dates of October 2021 through March 2022, the printed date on the label/carton reflects 6-month expiry. For
vials with expiry dates of June 2022 through December 2022, the printed date on the label/carton reflects
Transportation of vials - Purple Cap3
If local redistribution is needed, vials may be transported at:
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Ultra-low temperature between -90°C to -60°C (-130°F to -76°F)
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-25°C to -15°C (-13°F to 5°F), with any hours used for transport counting against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°F)
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2°C to 8°C (35°F to 46°F) after thawing for up to 12 hours, with these hours counting against the 1-month limit for storage at 2°C to 8°C (35°F to 46°F)
Frozen vials transported at -25°C to -15°C (-13°F to 5°F) may be returned one time to the recommended storage condition of -90°C to -60°C (-130°F to -76°F). Thawed vials should never be refrozen.
Medium Thermal Shipping Containers7
The vaccine is provided in a Medium Thermal Shipping Container. The thermal shipping container may be used as temporary storage for up to 30 days from delivery. Please refer to the storage and temperature guidelines available on this page.
If an ultra-low-temperature freezer is not available for storage, the thermal shipping container in which the vaccine arrives may be used as temporary storage for up to 30 days from delivery, when consistently re-filled with Dry Ice. Refer to the Dry Ice Replenishment Sheet. The thermal shipping container maintains a temperature range of -90°C to -60°C (-130°F to -76°F). Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an excursion from the recommended storage condition.6 Refer to return instructions for details.
Please review the Shipping and Handling Guidelines for Medium Thermal Shipping Containers.
Click here to learn more about returning the thermal shipping container or temperature-monitoring device.
Time and temperature considerations - Purple Cap7
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Do not open vial cartons until there is a need to remove vials for transfer, thawing, or use
-
Upon delivery:
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Inspect the thermal shipping container to confirm that ordered vial cartons were received
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Do not stack or place anything on top of the thermal shipping container
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Vial carton and vial handling between storage environments:
When possible, to protect the vials that will remain in the ultra-low-temperature 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.
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If using the thermal shipping container for storage
To help maintain the level of dry ice and the temperature of the vaccine product:-
24 hours: The thermal shipping container must be replenished with dry ice within 24 hours of receipt
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2x/Day: It is recommended that the thermal shipping container not be opened more than 2 times a day
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3 Minutes: The thermal shipping container should not be opened more than 3 minutes at a time
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5 Days: The thermal shipping container should be replenished with dry ice up to 5 times every 5 days
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Dry Ice can be hazardous. Take necessary precautions by reviewing the Dry Ice Safety Data Sheet, and consult with your Occupational Health Department. Ensure there is proper ventilation and wear safety goggles or safety glasses with side shields and waterproof insulated gloves when handling dry ice
Safely dispose - Purple Cap3,7
Discard vaccine vials that:
-
Have had the maximum number of complete doses extracted to administer vaccinations
-
Are more than 6 hours from time of dilution
Discard vaccine vials in a sharps container as medical waste to ensure they are permanently destroyed. Discard vial cartons as medical waste so they cannot be reused.
Safety Resources - Purple Cap
Storage, Shipping, and Handling Resources - Purple Cap
Ensuring the Authenticity of BioNTech and Pfizer's COVID-19 Vaccines
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Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccines, including how they are accessed and administered. We are actively monitoring for fraudulent offers of illegitimate vaccines to protect patients from products that might be dangerous and lead to serious and life-threatening harm
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The vaccines are only administered intramuscularly by a healthcare professional3,4
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The vaccines are not taken orally and are not available in a capsule or tablet form3,4
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Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and are dispensed in a vial as follows:
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For 6 months through 4 years of age, DILUTE BEFORE USE, Maroon Cap vials, the vial label includes a maroon border546
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For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border55
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For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border34
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For 12 years of age and older, DILUTE BEFORE USE, Purple Cap vials. Two versions of the vial label are in current circulation - with or without a purple border23
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Ensure the safety of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use.
To prevent counterfeits, discard vaccine vials in sharps containers and empty vial cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through government-authorized vaccination centers – such as doctor’s offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccines can only be administered by licensed healthcare professionals, or other individuals that are approved vaccinators, at government-authorized vaccination sites. Individual doses are not for sale8,98,128,128,99,13
If you suspect the vaccine you have purchased may be counterfeit, contact us at
To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.
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COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap.
Pfizer and BioNTech; July 8, 2022. -
COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap.
Pfizer and BioNTech; July 8, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap.
Pfizer and BioNTech; October 18, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap.
Pfizer and BioNTech; August 31, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap.
Pfizer and BioNTech; October 12, 2022. -
Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap.
Pfizer and BioNTech; August 31, 2022. -
Data on file. Pfizer Inc. New York, NY.
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COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
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McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.
