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Emergency Use Authorization (EUA)

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 6 months through 11 years of age. The emergency use of this product is 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. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

Select Important Vial Information

To Prevent Vaccine Administration Errors, Prior to Preparation and Administration:

Please verify that vial labels state Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).

Verify the vial cap color and label for the respective authorized age group.

Expiry Information

Expiry information for vaccine vials can be found at https://lotexpiry.cvdvaccine.com/.

Learn More

Formulation/Presentation Guide

Refer to the information outlined below for select information about the formulation and presentations.

Formulation/Presentation Guide

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6 Months Through 4 Years of Age 5 Through 11 Years of Age

For Eligible Individuals 6 Months Through 4 Years of Age

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
6 MONTHS THROUGH 4 YEARS* OF AGE, DILUTE BEFORE USE

Yellow Cap

Dosing Information

Dose

3 mcg†

Dose volume

0.3 mL†

Dilution‡

1.1 mL‡

Doses per vial

Multiple Dose Vial§:
3 doses per vial (after dilution)||

For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.

Storage Conditions

Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]

12 months#

Freezer
[-25°C to -15°C (-13°F to 5°F)]

DO NOT STORE

Refrigerator
[2°C to 8°C (35°F to 46°F)]

10 weeks

Room temperature
[8°C to 25°C (46°F to 77°F)]

12 hours prior to first puncture

After first puncture
[2°C to 25°C (35°F to 77°F)]

Discard 12 hours after the first puncture**

* For individuals turning from 4 to 5 years of age during the vaccination series, administer all doses with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders.

†After dilution, each 0.3 mL dose is formulated to contain 3 mcg of modRNA encoding Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

‡ ONLY use sterile 0.9% Sodium Chloride Injection, USP, as the diluent. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.

§ Low dead-volume syringes and/or needles are not required for multiple dose vial (MDV).

||If the amount of vaccine in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Do not pool excess vaccine from multiple vials.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/.

#Once vials are thawed, they should not be refrozen.

**After dilution, multiple dose vials should be held between 2°C to 25°C (35°F to 77°F). Multiple dose vials should be discarded 12 hours after dilution.

For Eligible Individuals 5 Through
11 Years of Age

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
5 THROUGH 11 YEARS* OF AGE, DO NOT DILUTE

Blue Cap

Dosing Information

Dose

10 mcg†

Dose volume

0.3 mL†

Dilution

DO NOT DILUTE

Doses per vial

Single Dose Vial‡:
1 dose per vial

For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.

Storage Conditions§

Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]

12 months

Freezer
[-25°C to -15°C (-13°F to 5°F)]

DO NOT STORE

Refrigerator
[2°C to 8°C (35°F to 46°F)]

10 weeks

Room temperature
[8°C to 25°C (46°F to 77°F)]

12 hours prior to use§

After puncture
[2°C to 25°C (35°F to 77°F)]

Use immediately; discard vial and any excess volume

* For individuals turning from 4 to 5 years of age during the vaccination series, administer all doses with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders.

† Each 0.3 mL dose is formulated to contain 10 mcg of modRNA encoding Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

‡ Low dead-volume syringes and/or needles are not required for single dose vial (SDV).

§ Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/.

Once vials are thawed, they should not be refrozen.

Shipping & Handling Resources

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Reference

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 11 years of age); BioNTech Manufacturing GmbH and Pfizer Inc.; December 08, 2023.

Eligible healthcare providers can order COVID-19 vaccines directly from Pfizer*†

Learn about ordering vaccines through Pfizer
Prime online or by calling 1-800-533-4535.

*†If preferred, orders may be placed with your facility's
wholesaler. All vaccine presentations may not be available directly through Pfizer.

IMPORTANT SAFETY INFORMATION

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AUTHORIZED USE

Indication & Authorized Use

IMPORTANT SAFETY INFORMATION

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Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age.

Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

Management of Acute Allergic Reactions

Appropriate medical treatment 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.

Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, 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. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to Pfizer-BioNTech COVID-19 Vaccine.

Limitation of Vaccine Effectiveness

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Solicited adverse reactions included:

  • 6 months through 23 months of age: Injection site redness; swelling and tenderness; decreased appetite; drowsiness; fever; irritability.
  • 2 through 11 years of age: Injection site pain; redness and swelling; chills; diarrhea; fatigue; fever; headache; new or worsened joint pain; new or worsened muscle pain; vomiting.

Vaccination providers must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA” in the description section of the report. To the extent feasible, report adverse events to Pfizer 1-800-438-1985 or provide a copy of the VAERS form to Pfizer https://
www.pfizersafetyreporting.com/

Please click for Pfizer-BioNTech COVID-19 Vaccine Vaccination Provider and
Recipient and Caregiver EUA Fact Sheets.

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age.


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Emergency Use Authorization
(EUA)

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 6 months through 11 years of age. The emergency use of this product is 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. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

AUTHORIZED: Effective 09/11/23

PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA) IS AUTHORIZED FOR EMERGENCY USE 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 THROUGH 11 YEARS OF AGE.

Click to view the EUA Fact Sheet for Vaccination Providers.

To prevent vaccine administration errors, prior to preparation and administration:

  • Please verify that vial labels state Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
  • Verify the vial cap color and label for the respective appropriate age group.

Please see the Formulation/Presentation Guide for more details.

Important Reminder:

Previous COVID-19 vaccines, including original monovalent COVID-19 vaccines and bivalent (original and Omicron BA.4/BA.5) mRNA COVID-19 vaccines are no longer authorized for use in the United States.

FDA and CDC guidance is to check inventory and dispose of previous COVID-19 vaccines according to state and local regulations.

Expiry Information

If cartons are received refrigerated at 2°C to 8°C (35°F to 46°F), they should be stored in a refrigerator at 2°C to 8°C (35°F to 46°F). Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons.


Read the Important Safety Information below and check back for
further updates.

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