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Storage and Handling

Ages 5 through 11 years,
DILUTE BEFORE USE
(Orange Cap)

FDA AUTHORIZED FOR EMERGENCY USE1

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.

STORAGE - ORANGE CAP

The 5 through 11 years, DILUTE BEFORE USE (Orange Cap) presentation may be stored in the refrigerator or in an ultra-low-temperature freezer1,2

Vials may be stored or transported at refrigerated temperatures of 2°C to 8°C (35°F to 46°F) for up to 10 weeks. Total cumulative time the vials are stored at 2°C to 8°C (35°F to 46°F) should not exceed 10 weeks. Vials may also be stored in an ultra-low-temperature freezer between -90°C to -60°C (-130°F to -76°F) for up to 9 months from the date of manufacture printed on the vial and cartons. Expiry information may be updated periodically, click here for updated expiry information.


Storage Storage
 

Vial storage prior to use - Orange Cap1

  • Cartons of the vaccine will arrive frozen 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
  • 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 manufacture are shown below. Expiry Information may be updated periodically, click here for updated expiry information.
    Printed Manufacturing Date 9-Month Expiry Date
    June 2021 February 28, 2022
    July 2021 March 31, 2022
    August 2021 April 30, 2022
    September 2021 May 31, 2022
    October 2021 June 30, 2022
    November 2021 July 31, 2022
    December 2021 August 31, 2022
    January 2022 September 30, 2022
    February 2022 October 31, 2022
    March 2022 November 30, 2022

Vial storage during use - Orange Cap1

  • If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes
  • Vials with orange caps and labels with orange borders may be stored at 8°C to 25°C (46°F to 77°F) for a total of 12 hours prior to dilution
  • After dilution, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution
  • Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in the EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap supersedes the number of hours printed on vial labels and cartons

Transportation of vials - Orange Cap1

If local redistribution is needed, vials may be transported at -90°C to -60°C (-130°F to -76°F) or 2°C to 8°C (35°F to 46°F). Thawed vials should never be refrozen.



Single-Use and Medium Thermal Shipping Containers2

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

Please review the Shipping and Handling Guidelines for Medium Thermal Shipping Containers.

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





Time and temperature considerations - Orange Cap2

  • 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:
    • 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 - Orange Cap1,2

Discard vaccine vials that:

  • Have had the maximum number of complete doses extracted to administer vaccinations
  • Are more than 12 hours from time of dilution

Discard vaccine vials in a sharps container as medical waste to ensure they are permanently destroyed. Discard vial cartons as medical waste so they cannot be reused.

Safety and Storage Resources - Orange Cap

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 - Orange Cap

Checklist for Storage, Handling, and Preparation
Checklist for Storage, Handling, and Preparation
Updated 03/29/2022
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
Shipping and Handling Guidelines - Single-Use Thermal Shipping Container
Shipping and Handling Guidelines - Medium Thermal Shipping Container
Updated 10/04/2021
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 professional1
    • The vaccine is not taken orally and is not available in a capsule or tablet form1
  • 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 border3
    • For Ages 12 years and older DO NOT DILUTE Gray Cap vials, the vial label includes a gray border4
    • For Ages 5 through 11 years DILUTE BEFORE USE Orange Cap vials, the vial label includes an orange border1
  • 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 sale5,6

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. 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.
  2. Data on File. Pfizer Inc. New York, NY.
  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; January 31, 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; January 31, 2022.
  5. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  6. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

Indication & Authorized Use

Indication & Authorized Use

Important Safety Information

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Indication & Authorized Use

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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, including this vaccine. 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



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