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EUA FACT SHEETS

Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet for Recipients and Caregivers

The Pfizer-BioNTech COVID-19 Vaccine should be preferably stored in an ultra-low-temperature (ULT) freezer between -80°C to -60°C (-112°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.

The Pfizer-BioNTech COVID-19 Vaccine is provided in either 25-pack or 195-pack cartons. The thermal shipping container included with the 25-pack cartons should be returned within 10 days of delivery and should not be used as temporary storage. Please refer to the storage and temperature guidelines available on this page, as well as in the Q&A section of this website.

If an ultra-low-temperature freezer is not available for the 195-pack cartons, the thermal shipping container in which the Pfizer-BioNTech COVID-19 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 guidelines. 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.

For the thermal shipping container to maintain the ultra-low temperatures required, it is recommended that the thermal shipping container itself be stored at 15°C to 25°C (59°F to 77°F).

Vaccination Storage & Dry Ice Safety Handling

Updated as of
6/10/2021

Checklist for Storage, Handling, and Preparation of the Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine Video (A Guide to Product Handling and Administration at Your Vaccination Center)

A chapterized video guide detailing the storage and handling, preparation and administration, and thermal shipping container return processes for the Pfizer-BioNTech COVID-19 Vaccine.

Chapter 1: Storage and Handling

How to store and handle the thermal shipping container, dry ice, and vaccine vial cartons.

Updated as of 6/25/2021

Watch

Chapter 2: Preparation and Administration

How to properly thaw the multiple dose vials, as well as how to prepare and administer the vaccine to recipients.

Updated as of 6/25/2021

Watch

Safety and Storage

Updated as of
2/16/2021

Safe Handling Guidelines for Dry Ice

Facts about dry ice, general safety guidance, and disposal procedures.

Dry Ice Safety Data Sheet

Access the Dry Ice Safety Data Sheet.

Product Safety Data Sheet

Access the Pfizer-BioNTech COVID-19 Vaccine Product Safety Data Sheet.

Updated as of
5/21/2021

195-pack Pfizer-BioNTech COVID-19 Vaccine Shipping and Handling Guidelines

Updated as of
5/19/2021

25-pack Pfizer-BioNTech COVID-19 Vaccine Shipping and Handling Guidelines

Dry Ice Resources

Updated as of
5/20/2021

Dry Ice Replenishment Sheet

Information on dry ice replenishment, pellet size, and pack-out instructions for dry ice replenishment of thermal packaging.

Returning Your Thermal Shipping Container

Updated as of
6/16/2021

Instructions for Returning Real-Time Temperature Monitor and Thermal Shipping Container

Pfizer-BioNTech COVID-19 Vaccine Storage and Handling

  • Storage times and transfer times between storage environments are the same for both 25-pack and 195-pack cartons
  • 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 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.

  • Originating Temperature Environment Maximum Time at Room Temperature (up to 25°C or up to 77°F) During Storage or Transfer Time Required to Stay in Frozen Environment After Room Temperature Exposure During Transfer Number of Times Vial Cartons May Be Transferred to the Preferred ULT Freezer Storage Condition
    Unopened Vial Cartons
    Opened Vial Cartons

    From ULT Freezer
    -80°C to -60°C
    (-112°F to -76°F)

    Or

    From Thermal Shipping Container*
    -90°C to -60°C
    (-130°F to -76°F)

    Up to 5 minutes

    Up to 3 minutes

    At least 2 hours before they can be removed again

    N/A

    From Freezer
    -25°C to -15°C
    (-13°F to 5°F)

    Up to 3 minutes

    Up to 1 minute

    No specified time before they can be taken out again

    Limit ONE return to ULT Freezer;
    Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks

    *

    The thermal shipping container should not be opened for more than 3 minutes at a time.

    If possible, opened cartons should be left in the -25°C to -15°C (-13°F to 5°F) environment when removing vials for use. If the carton must be removed from the freezer, return to freezer in less than 1 minute.

  • If using the thermal shipping container for storage (195-pack cartons only)
    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
    • 2x/Day: It is recommended that the thermal shipping container not be opened more than 2 times a day
    • 3 Minutes: The thermal shipping container should not be opened more than 3 minutes at a time
    • 5 Days: The thermal shipping container should be replenished with dry ice every 5 days
  • 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

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Frozen Vials Prior to Use

  • Vials must be kept frozen and protected from light, in the original cartons, until ready to use
  • Vial cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials 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 -80°C to -60°C (-112°F to -76°F) until the expiry date printed on the label
  • The thermal shipping container included with the 25-pack cartons should be returned within 10 days of delivery and should not be used as temporary storage
  • Alternatively, vials may be stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks. Vials stored at -25°C to -15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -80°C to -60°C (-112°F to -76°F). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks
  • If an ultra-low-temperature freezer is not available for the 195-pack carton, 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 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 (-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

Transportation of Frozen Vials

  • If local redistribution is needed and full vial cartons containing vials cannot be transported at -90°C to -60°C (-130°F to -76°F), vials may be transported at -25°C to -15°C (-13°F to 5°F)
  • Any hours used for storage or transport at -25°C to -15°C (-13°F to 5°F) count against the 2-week limit for storage at -25°C to -15°C (-13°F to 5°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 -80°C to -60°C (-112°F to -76°F)

Thawed Vials Before Dilution

Thawed Under Refrigeration

  • Thaw and then store undiluted vials in the refrigerator [2°C to 8°C (35°F to 46°F)] for up to 1 month. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time

Thawed at Room Temperature

  • For immediate use, thaw undiluted vials at room temperature [up to 25°C (77°F)] 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

  • Available data support transportation of one or more thawed vials at 2°C to 8°C (35°F to 46°F) for up to 12 hours

Vials After Dilution

  • After dilution, store vials between 2°C to 25°C (35°F to 77°F) 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

For a visual guide to storage options for the Pfizer-BioNTech COVID-19 Vaccine, refer to "How is the vaccine stored?" in the Q&A section.

Safely Dispose

Discard vaccine vials that:

  • Have been fully discharged and used 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.


  • Important Safety Information

    • Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine

      Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html)

    • Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances
    • Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
    • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
    • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
    • In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
    • Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials:
      • severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm)
      • myocarditis and pericarditis

      Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine

    • Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
    • Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
    • There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
    • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
    • Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
    • Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com


For more information

Medical Information
Visit PfizerMedicalInformation.com or call 1-800-438-1985.

General Product Inquiries
Call 1-877-829-2619.

Shipment Support
US Trade Customer Service
Call 1-800-666-7248.