Skip to main content

Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve.
Click here to learn how we are responding.

Storage & Handling

Ages 12 years and older

FDA APPROVED FOR INDIVIDUALS ≥16 YEARS OF AGE - TWO DOSE PRIMARY SERIES1

In individuals 16 years of age and older, COMIRNATY® (COVID-19 Vaccine, mRNA)* has been approved for active immunization to prevent COVID-19 caused by SARS-CoV-2.1 COMIRNATY® (COVID-19 Vaccine, mRNA) is also known as the Pfizer-BioNTech COVID-19 Vaccine.2


FDA AUTHORIZED FOR EMERGENCY USE2,3

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 5 years 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.

gray cap Do Not
Dilute
Purple cap Dilute Before Use

STORAGE - GRAY CAP

Ages 12 years and older, DO NOT DILUTE (Gray Cap) presentation may be stored in a refrigerator for up to 10 weeks3


Ages 12 years 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 Cap3

  • 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  • After the first dose is withdrawn, the vial should be stored at 2°C to 25°C (35°F to 77°F).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, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons. Expiry dates based on 9 months from the date of the manufacture are shown below. Expiry Information may be updated periodically, click here for updated expiry information

Printed Manufacturing Date

06/2021

07/2021

08/2021

09/2021

10/2021

11/2021

12/2021

01/2022

02/2022

03/2022

9-Month Expiry Date

28-Feb-2022

31-Mar-2022

30-Apr-2022

31-May-2022

30-Jun-2022

31-Jul-2022

31-Aug-2022

30-Sep-2022

31-Oct-2022

30-Nov-2022

Transportation of vials - Gray Cap3

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 Containers4

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 Cap4

  • 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 Cap3,4

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 03/29/2022
Shipping and Handling Guidelines - Medium Thermal Shipping Container
Shipping and Handling Guidelines - Medium Thermal Shipping Container
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
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 Ages 12 years and older, DILUTE BEFORE USE (Purple Cap) presentation2


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 with an expiry date of September 2021 through March 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 below. Expiry Information may be updated periodically, click here for updated expiry information.

Printed Date

September 2021

October 2021

November 2021

December 2021

January 2022

February 2022

March 2022

Updated Expiry Date

December 2021

January 2022

February 2022

March 2022

April 2022

May 2022

June 2022

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.

Regardless of storage condition, vaccine should not be used past the 9-month expiry. For vials with expiry dates through March 2022: 6 months printed on the vial plus an additional 3 months. For vials with expiry dates after March 2022: vials will already reflect the 9-month shelf life.


Transportation of vials - Purple Cap2

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 Containers4

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.

Medium ULT Icon





Time and temperature considerations - Purple Cap4

  • 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 Cap2

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 the vaccine with an expiry date of September 2021 through March 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 below.* Expiry Information may be updated periodically, click here for updated expiry information.

    Printed Date

    September 2021

    October 2021

    November 2021

    December 2021

    January 2022

    February 2022

    March 2022

    Updated Expiry Date

    December 2021

    January 2022

    February 2022

    March 2022

    April 2022

    May 2022

    June 2022

    *Regardless of storage condition, vaccine should not be used past the 9-month expiry. For vials with expiry dates through March 2022: 6 months printed on the vial plus an additional 3 months. For vials with expiry dates after March 2022: vials will already reflect the 9-month shelf life.

  • 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 Cap2,4

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 03/29/2022
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 professional2,3
    • The vaccine is not taken orally and is not available in a capsule or tablet form2,3
  • 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 Ages 12 years and older DILUTE BEFORE USE Purple Cap vials. Two versions of the vial label are in current circulation - with or without a purple border2
    • For Ages 12 years and older DO NOT DILUTE Gray Cap vials, the vial label includes a gray border3
    • For Ages 5 through 11 years DILUTE BEFORE USE Orange Cap vials, the vial label includes an orange border5
  • 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 sale6,7

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. Pfizer and BioNTech; December 16, 2021.
  2. 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; January 31, 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), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; January 31, 2022.
  4. Data on File. Pfizer Inc. New York, NY.
  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; January 03, 2022.
  6. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  7. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

Indication & Authorized Use

Authorized Use & Indication

Important Safety Information

MORE

Indication & Authorized Use

MORE

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.

Interchangeability

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap), when prepared according to their respective instructions for use, can be used interchangeably. COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older (purple cap and gray cap) should not be used for individuals 5 through 11 years of age, because of the potential for vaccine administration errors, including dosing errors.

Authorized Use

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

  • a 2-dose 30 mcg modRNA primary series to individuals 12 through 15 years of age
  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved 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
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

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 2-dose 10 mcg modRNA primary series to individuals 5 through 11 years of age
  • a 2-dose 30 mcg modRNA primary series to individuals 12 years of age and older
  • a third 10 mcg modRNA primary series dose to individuals 5 through 11 years of age who have been determined to have certain kinds of immunocompromise
  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved 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
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine; and
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine



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. The observed risk is higher among males under 40 years of age than among females and older males. 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 (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


For More Information

Medical Information Medical Information

Medical Information

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

General Product Inquiries General Product Inquiries

General Product Inquiries

Call 1-877-829-2619

Shipment Support US Trade Customer Service Shipment Support US Trade Customer Service

Shipment Support
US Trade Customer Service

Call 1-800-666-7248

Pfizer Customer Service Pfizer Customer Service

Pfizer Customer Service

Call 1-800-879-3477