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Storage & Handling

12 years of age and older

FDA Approved for: Individuals 12 years of age and older, DILUTE BEFORE USE (Purple Cap) AND DO NOT DILUTE (Gray Cap) presentations.

COMIRNATY® (COVID-19 Vaccine, mRNA): FDA APPROVED FOR INDIVIDUALS 12 YEARS OF AGE AND OLDER AS A TWO-DOSE PRIMARY SERIES1,2

In individuals 12 years of age and older, COMIRNATY® (COVID-19 Vaccine, mRNA)* has been approved as a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2.


Pfizer-BioNTech COVID-19 Vaccine: FDA AUTHORIZED FOR EMERGENCY USE3-6

Emergency uses of the vaccine 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 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

*When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Because of the potential for vaccine administration errors, including dosing errors, COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

For vaccination of individuals advancing into the next age group (4 years of age turning 5 years of age or 11 years of age turning 12 years of age) between any primary series dose, refer to the respective age-based Fact Sheet for Healthcare Providers for instructions for administration.

gray cap Do Not
Dilute
Purple cap 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.

refrigerator refrigerator

Vial storage prior to use - Gray Cap4

  • Cartons of the vaccine may arrive at ultra-cold conditions in thermal containers with dry ice
  • 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
    • The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer
  • 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
  • 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
  • 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
  • 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
  • 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

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 Pre-labeled Return Box to help Pfizer fulfill its commitment to reusable resources. Do not return vaccine or vaccine vials.

Click here to learn more about returning the thermal shipping container or temperature-monitoring device.

Medium Thermal Shipping Container

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

  • 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:

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.


From ULT Freezer From ULT Freezer

  • 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:

  • Have had the maximum number of complete doses extracted to administer vaccinations
  • 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

Safe Handling for Dry Ice
Safe Handling for Dry Ice
Dry Ice Safety Data Sheet
Dry Ice Safety Data Sheet
Product Safety Data Sheet
Product Safety Data Sheet - Pfizer-BioNTech COVID-19 Vaccine - Tris-Sucrose (applies to Gray Cap and Orange Cap)

Storage, Shipping, and Handling Resources - Gray Cap

Checklist for Storage, Handling, and Preparation
Checklist for Storage, Handling, and
Preparation
Updated 07/08/2022
Shipping and Handling Guidelines - Medium Thermal Shipping Container
Shipping and Handling Guidelines - Medium Thermal Shipping Container
Updated 01/24/2022
Return Instructions for Medium and Single-Use Thermal Shipping Containers
Learn more about returning the thermal shipping container or temperature-monitoring device
Updated 11/19/2021
Shipping and Handling Guidelines - Single-Use Thermal Shipping Container
Shipping and Handling Guidelines - Single-Use Thermal Shipping Container
Updated 01/24/2022
Dry Ice Replenishment Sheet
Dry Ice Replenishment Sheet
Updated 11/05/2021

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 between 2°C to 8°C (35°F to 46°F) for up to 1 month.


Freezer Freezer  

*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 9-month expiry. The vaccine should not be used past the 12-month (updated) expiry date in the table above.


Transportation of vials - Purple Cap3

If local redistribution is needed, vials may be transported at:

  • Ultra-low temperature between -90°C to -60°C (-130°F to -76°F)
  • -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)
  • 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.

Medium ULT Icon



Time and temperature considerations - Purple Cap7

  • 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 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.


temperature invironment temperature invironment


  • 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
    • 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 up to 5 times 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


Vial handling - Purple Cap3

OPEN ALL

CLOSE ALL

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 Multiple Dose Vials 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 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

    *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 9-month expiry. The vaccine should not be used past the 12-month (updated) expiry date in the table above.

  • 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 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 -90°C to -60°C (-130°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

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

Safe Handling for Dry Ice
Safe Handling for Dry Ice
Dry Ice Safety Data Sheet
Dry Ice Safety Data Sheet
Product Safety Data Sheet
Product Safety Data Sheet - Pfizer-BioNTech COVID-19 Vaccine (applies to Purple Cap)

Storage, Shipping, and Handling Resources - Purple Cap


Checklist for Storage, Handling, and Preparation
Checklist for Storage, Handling,
and Preparation
Updated 07/08/2022
Pfizer-BioNTech COVID-19 Vaccine Shipping and Handling Guidelines
Pfizer-BioNTech COVID-19 Vaccine Shipping and Handling Guidelines
Updated 10/04/2021
Return Instructions for Medium and Single-Use Thermal Shipping Containers
Learn more about returning the thermal shipping container or temperature-monitoring device
Updated 11/19/2021
Dry Ice Replenishment Sheet
Dry Ice Replenishment Sheet
Updated 11/05/2021

Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine and Registered Trademark Name COMIRNATY®

  • Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccine, including how it is 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
    • The vaccine is only administered intramuscularly by a healthcare professional3,4
    • The vaccine is not taken orally and is not available in a capsule or tablet form3,4
  • Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and are dispensed in a vial as follows:
    • For 6 months through 4 years of age, DILUTE BEFORE USE, Maroon Cap vials, the vial label includes a maroon border546
    • For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border55
    • For 12 years of age and older, DO NOT DILUTE, Gray Cap vials, the vial label includes a gray border34
    • 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
  • 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 vaccine 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 1-800-438-1985 or visit https://www.pfizer.com/products/product-contact-information.

To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.


References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; July 8, 2022.
  2. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; July 8, 2022.
  3. 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; July 8, 2022.
  4. 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; July 8, 2022.
  5. 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; June 17, 2022.
  6. 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; June 17, 2022.
  7. Data on file. Pfizer Inc. New York, NY.
  8. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  9. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

Indication & Authorized Use

Indication & Authorized Use

Important Safety Information

MORE

Important Safety Information

MORE



Indication & Authorized Use


COMIRNATY® (COVID-19 Vaccine, mRNA) 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 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

Pfizer-BioNTech COVID-19 Vaccine

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Because of the potential for vaccine administration errors, including dosing errors, vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.



Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of these vaccines.

Management of Acute Allergic Reactions

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, COMIRNATY, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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).

Myocarditis and Pericarditis

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

Syncope

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.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Limitation of Effectiveness

Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.

Adverse Reactions

Primary Series Adverse Events:

Pfizer-BioNTech COVID-19 Vaccine

In a clinical study (3 mcg modRNA) in participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (3 mcg modRNA) in participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

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%).

Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY

In clinical studies (30 mcg modRNA) of adolescents 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) were 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%), and injection site redness (8.6%).

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%).

Booster Dose Adverse Events:

Pfizer-BioNTech COVID-19 Vaccine

In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).

Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY

In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first 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%).

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent is based on:

  • safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1),
  • safety data from clinical trials which evaluated primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, and
  • post marketing safety data with Pfizer-BioNTech COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants 55 years of age and older. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).

In a clinical study of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of Pfizer-BioNTech COVID-19 Vaccine 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%).

Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

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

Before administration of Pfizer-BioNTech COVID-19 Vaccine, please click to see







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