Storage & Handling
5 through 11 years of age,
DILUTE BEFORE USE
(Orange Cap)
Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech
STORAGE - ORANGE CAP
The 5 through 11 years, DILUTE BEFORE USE (Orange Cap) presentation may be stored in the refrigerator or in an ultra-low-temperature freezer1,5
Vials may be stored or transported at refrigerated temperatures of 2°C to 8°C (35°F to 46°F) for up to 10 weeks. Total cumulative time the vials are stored at 2°C to 8°C (35°F to 46°F) should not exceed 10 weeks. Vials may also be stored in an ultra-low-temperature
freezer between -90°C to -60°C (-130°F to -76°F) for up to 9 months from the date of manufacture printed on the vial and cartons. Expiry information may be updated periodically,
Vial storage prior to use - Orange Cap1
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Cartons of the vaccine will arrive frozen 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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Regardless of storage condition, orange 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 manufacture are shown below. Expiry Information may be updated periodically, click here for updated expiry information.Printed Manufacturing Date 12-Month Expiry Date 07/2021 30-Jun-2022 08/2021 31-Jul-2022 09/2021 31-Aug-2022 10/2021 30-Sep-2022 11/2021 31-Oct-2022 12/2021 30-Nov-2022 01/2022 31-Dec-2022 02/2022 31-Jan-2023
Vial storage during use - Orange Cap1
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If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes
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Vials with orange caps and labels with orange borders may be stored at 8°C to 25°C (46°F to 77°F) for a total of 12 hours prior to dilution
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After dilution, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution
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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 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, Orange Cap supersedes the number of hours printed on
vial labels and cartons
Transportation of vials - Orange Cap1
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 Containers5
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
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 - Orange Cap5
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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:
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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 - Orange Cap1,5
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 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 and Storage Resources - Orange Cap
Storage, Shipping, and Handling Resources - Orange 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 professional1
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The vaccines are not taken orally and are not available in a capsule or tablet form1
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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 border446
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For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border15
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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 sale6,78,128,128,99,13
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.
- 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) (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) (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.
- COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
- McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.
