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Storage and Handling

Orange Cap Vial Image

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

FDA AUTHORIZED FOR EMERGENCY USE1-4

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.

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 freezer1,5

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, orange 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 manufacture are shown below. Expiry Information may be updated periodically, click here for updated expiry information.
    Printed Manufacturing Date 12-Month Expiry Date
    07/2021 30-Jun-2022
    08/2021 31-Jul-2022
    09/2021 31-Aug-2022
    10/2021 30-Sep-2022
    11/2021 31-Oct-2022
    12/2021 30-Nov-2022
    01/2022 31-Dec-2022
    02/2022 31-Jan-2023

Vial storage during use - Orange Cap1


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 Containers5

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 Cap5

  • 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

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

  • 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 Cap1,5

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

Storage, Shipping, and Handling Resources - Orange Cap

Checklist for Storage, Handling, and Preparation
Checklist for Storage, Handling, and Preparation
Updated 07/08/2022
CLICK HERE
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
CLICK HERE
Shipping and Handling Guidelines - Single-Use Thermal Shipping Container
Shipping and Handling Guidelines - Single-Use Thermal Shipping Container
Updated 01/24/2022
CLICK HERE
Shipping and Handling Guidelines - Single-Use Thermal Shipping Container
Shipping and Handling Guidelines - Medium Thermal Shipping Container
Updated 01/24/2022
CLICK HERE
Dry Ice Replenishment Sheet
Dry Ice Replenishment Sheet
Updated 11/05/2021
CLICK HERE

Related pages:

Storage & Handling Dosing & Preparation Safety & Efficacy

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 6 months through 4 years of age, DILUTE BEFORE USE, Maroon Cap vials, the vial label includes a maroon border446
    • For 5 through 11 years of age, DILUTE BEFORE USE, Orange Cap vials, the vial label includes an orange border15
    • 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 sale6,78,128,128,99,13

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. 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.
  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; 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), DO NOT DILUTE, Gray 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) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap. Pfizer and BioNTech; June 17, 2022
  5. Data on file. Pfizer Inc. New York, NY.
  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

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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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

Fact Sheets for individuals 6 months through 4 years of age
EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age),
DILUTE BEFORE USE, Maroon Cap
Recipients and Caregivers Fact Sheet (6 months through 4 years of age)
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)


Before administration of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), please click to see
EUA Fact Sheet for Vaccination Providers, Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose 12 years of age and older), DO NOT DILUTE, Gray Cap
Recipients and Caregivers Fact Sheet: (Primary Series and Bivalent Booster Dose 12 years of age and older)


Before administration of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA), please click to see
Full Prescribing Information (Primary Series 12 years of age and older), DO NOT DILUTE, Gray Cap
Full Prescribing Information (Primary Series 12 years of age and older), DILUTE BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (Primary Series 12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (Primary Series 12 years of age and older), DILUTE BEFORE USE, Purple Cap
Recipients and Caregivers Fact Sheet: (Primary Series and Bivalent Booster Dose 12 years of age and older)


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

Now Authorized: Effective 08/31/22

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) IS NOW AUTHORIZED FOR EMERGENCY USE AS A SINGLE BOOSTER DOSE IN ELIGIBLE INDIVIDUALS 12 YEARS OF AGE AND OLDER

Click to view the newly authorized EUA Fact Sheet for Vaccination Providers, Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose 12 years of age and older), DO NOT DILUTE, Gray Cap

Emergency Use Authorization

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 aged 12 years 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.

Authorized Use

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

This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Vaccination Schedule

A single booster dose (0.3 mL) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine.

*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.

Selected Safety Information

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

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, 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 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).


Verify the vials (including labels) prior to preparation and administration to help avoid dosing errors. Check gray cap vial label to ensure that the name on the vial states “Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).” Please see the Formulation/Presentation Guide for more details.

Formulation/
Presentation Guide
Select FAQs

Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vials and cartons.

I acknowledge that this website is being updated on an ongoing basis. I have read the Important Safety Information. I will check back for further updates.

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