Full Prescribing Information & EUA Fact Sheets

FDA EUA Letter Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers (12 Years & Up) – DILUTE BEFORE USE, Purple Cap EUA Fact Sheet for Vaccination Providers (12 Years & Up) – DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers (5 to <12 Years Old) – DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Recipients and Caregivers - 12 Years & Up EUA Fact Sheet for Recipients and Caregivers (5 to <12 Years Old)

Three vaccine presentations are now available with different preparation and storage guidelines.
See immediately below for information on Gray Cap and Orange Cap vials.

For dosing, preparation, and storage guidelines for Ages 12 years and older DO NOT DILUTE Gray Cap presentation:

View the EUA Fact Sheet for Vaccination Providers

Click here for expiry information.

For dosing, preparation, and storage guidelines for Ages 5 through 11 years DILUTE BEFORE USE Orange Cap presentation:

View the EUA Fact Sheet for Vaccination Providers

Click here for expiry information.

Unless otherwise specified, the remainder of the website applies only to the Ages 12 & Up DILUTE BEFORE USE Purple Cap Presentation.

Vaccination Storage & Dry Ice Safety Handling

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. See further information here. 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.1

The 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.3 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 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.1

Updated as of
10/11/2021

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

Safety and Storage

Updated as of
02/16/2021

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.

Returning Your Thermal Shipping Container

Storage and Handling3

  • 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
    -90°C to -60°C
    (-130°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

Open all

Close all

Frozen Vials Prior to Use1

  • Vials must be kept frozen and protected from light, in the original cartons, until ready to use
  • Vial cartons of the 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 -90°C to -60°C (-130°F to -76°F) until the expiry date printed on the label. This information in the package insert supersedes the storage conditions printed on the vial cartons
  • Cartons and vials of the vaccine with an expiry date of May 2021 through February 2022 printed on the label may remain in use for 3 months beyond the printed date as long as approved storage conditions between ‑90°C to ‑60°C (‑130°F to ‑76°F) have been maintained. Updated expiry dates are shown below2
    Printed Expiry Date2 Updated Expiry Date2
    May 2021 August 2021
    June 2021 September 2021
    July 2021 October 2021
    August 2021 November 2021
    September 2021 December 2021
    October 2021 January 2022
    November 2021 February 2022
    December 2021 March 2022
    January 2022 April 2022
    February 2022 May 2022
  • If not stored between -90°C to -60°C (-130°F to -76°F), 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 -90°C to -60°C (-130°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 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 Vials1

  • 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 -90°C to -60°C (-130°F to -76°F)

Thawed Vials Before Dilution1

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, 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 Vials1

  • 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 Dilution1

  • 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 vaccine, refer to "How is the vaccine stored?" in the Q&A section.


Safely Dispose1,3

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

    Indication & Authorized Use

    Important Safety Information

    • Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the 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 the vaccine.

    • Monitor 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).

    • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.

    • 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 vaccine.

    • The vaccine may not protect all vaccine recipients.

    • Primary Series Adverse Events:
      In clinical studies (30 mcg modRNA) of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).

    • In clinical studies (30 mcg modRNA) of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).

    • In a clinical study (30 mcg modRNA) of adolescents 12 through 15 years of age, adverse reactions following the administration of the primary series 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%).

    • In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

    • Booster Dose Adverse Events:
      In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

    • Before administration of the vaccine, please click to see
      Fact Sheets and Prescribing Information for individuals 12 years of age and older
      Full Prescribing Information (16 years of age and older)
      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
      Recipients and Caregivers Fact Sheet (12 years of age & older)
      Fact Sheets for individuals 5 through 11 years of age
      EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
      Recipients and Caregivers Fact Sheet (5 through 11 years of age)

    Indication & Authorized Use

    The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the 2 EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.


    COMIRNATY® (COVID-19 Vaccine, mRNA) and the 2 formulations of Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 5 through 11 years of age because of the potential for vaccine administration errors, including dosing errors.


    Indication

    COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

    Authorized Use

    The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older to provide:

    • a 10 mcg modRNA 2-dose primary series to individuals 5 through 11 years of age
    • a 30 mcg modRNA 2-dose primary series to individuals 12 years of age and older
    • a 30 mcg modRNA third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination

    COMIRNATY® (COVID-19 Vaccine, mRNA) is authorized for emergency use to provide:

    • a 30 mcg modRNA 2-dose primary series to individuals 12 through 15 years of age
    • a 30 mcg modRNA third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination

References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; August 23, 2021.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Pfizer and BioNTech; October 20, 2021.
  3. Data on File. Pfizer Inc. New York, NY.
  4. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  5. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

For more information

Pfizer Customer Service
Call 1-800-879-3477.

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.