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Emergency Use Authorization (EUA)

Emergency uses of COVID-19 vaccines from BioNTech and Pfizer, including Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula), 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. Emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical products 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.

Vaccine Presentation & Dosing Guide
Yellow Cap Vial Yellow Cap Vial

Yellow Cap

6 Months Through 4 Years of Age

by Pfizer-BioNTech COVID-19 Vaccination Status1

NUMBER OF PREVIOUS DOSES OF
PFIZER-BIONTECH COVID-19 VACCINE(S)*

0 Previous Doses Received†

Not previously vaccinated with any COVID-19 vaccine.

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
Dosing Regimen, Dose, and Schedule

3 doses,‡ 0.3 mL per dose

Dose 1: Week 0 administer first dose

Dose 2: Administer 3 weeks after Dose 1

Dose 3: Administer ≥8 weeks after Dose 2

NUMBER OF PREVIOUS DOSES OF
PFIZER-BIONTECH COVID-19 VACCINE(S)*

1 Previous Dose Received

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
Dosing Regimen, Dose, and Schedule

2 doses,‡ 0.3 mL per dose

Dose 1:

Administer 3 weeks after receipt of previous dose of the Pfizer-BioNTech COVID-19 Vaccine*

Dose 2: Administer ≥8 weeks after Dose 1

NUMBER OF PREVIOUS DOSES OF
PFIZER-BIONTECH COVID-19 VACCINE(S)*

≥2 Previous Doses Received

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)
Dosing Regimen, Dose, and Schedule

Single dose, 0.3 mL

Administer ≥8 weeks after receipt of the last previous dose of Pfizer‑BioNTech COVID-19 Vaccine*

*Previous dose refers to a dose of any prior Pfizer-BioNTech COVID-19 vaccine that is no longer authorized for use in the United States.

†Not previously vaccinated with any COVID-19 vaccine.

‡For individuals turning from 4 to 5 years of age during the vaccination series who have received 1 or 2 doses of Pfizer-BioNTech COVID-19 vaccine, administer a single dose of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) supplied in vials with blue caps and labels with blue borders, on or after the date the individual turns 5 years of age.

Yellow Cap Vial Yellow Cap Vial

Yellow Cap

Immunocompromised Individuals
6 Months Through 4 Years of Age

by Pfizer-BioNTech COVID-19 Vaccination Status1

Individuals 6 months through 4 years of age with certain kinds of immunocompromise§ should complete at least a 3-dose series with an age-appropriate dose and dosing schedule|| of a COVID-19 vaccine. At least 1 dose should be with a COVID-19 Vaccine (2024-2025 Formula).

  • If previously not vaccinated, complete the 3-dose series with age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula).
  • If previously vaccinated with 1 or 2 dose(s) of a prior Pfizer-BioNTech COVID-19 vaccine, complete the remaining dose(s) in the 3-dose series with age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula).
  • If previously vaccinated with 3 or more doses of a prior COVID-19 vaccine, administer a single, age-appropriate dose of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) at least 2 months following the last dose.

§Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

||Dosing schedule for immunocompromised individuals 6 months through 4 years of age for Pfizer-BioNTech COVID-19 Vaccines: Dose 1: Week 0; Dose 2: Week 3; Dose 3: ≥8 Weeks after Dose 2. For individuals turning from 4 to 5 years of age during the vaccination series, complete the series with doses of Pfizer-BioNTech COVID-19 Vaccine (2024−2025 Formula) supplied in vials with blue caps and labels with blue borders on or after the date the individual turns 5 years of age.

These prior COVID-19 vaccines are no longer authorized for use in the United States.

The EUA Fact Sheet states that for individuals turning from 4 to 5 years of age during the vaccination series who have received 1 or 2 doses of Pfizer-BioNTech COVID-19 vaccine, administer a single dose of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) supplied in vials with blue caps and labels with blue borders, on or after the date the individual turns 5 years of age.1
Reference

1. Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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.; August 22, 2024.

Ordering available through Pfizer Prime*

Orders for 2024-2025 formula COVID-19 vaccines by BioNTech and Pfizer can be placed by eligible
healthcare professionals directly with Pfizer through Pfizer Prime online or by calling 1-800-533-4535.

Visit Pfizer Prime

*Eligible healthcare providers can order COVID-19 vaccines directly from
Pfizer. If preferred, orders may be placed with your facility’s wholesaler.

Vaccine Presentation & Dosing Guide
Blue Cap Vial

Blue Cap

5 Through 11 Years of Age
Irrespective of COVID-19 Vaccination Status1

A single dose; 0.3 mL

If previously vaccinated, administer ≥2 months after receipt of last previous dose of COVID-19 vaccine.*

*Previous dose refers to a dose of any prior COVID-19 vaccine that is no longer authorized for use in the United States.

Blue Cap Vial

Blue Cap

Immunocompromised Individuals
5 Through 11 Years of Age

by Pfizer-BioNTech COVID-19 Vaccination Status1

Individuals 5 through 11 years of age with certain kinds of immunocompromise† should complete at least a 3-dose series with an age-appropriate dose and dosing schedule‡ of a COVID-19 vaccine. At least 1 dose should be with a COVID-19 Vaccine (2024-2025 Formula).

  • If previously not vaccinated, complete the 3-dose series with age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula).
  • If previously vaccinated with 1 or 2 dose(s) of a prior Pfizer-BioNTech COVID-19 vaccine,§ complete the remaining dose(s) in the 3-dose series with age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula).
  • If previously vaccinated with 3 or more doses of a prior COVID-19 vaccine,§ administer a single, age-appropriate dose of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) at least 2 months following the last dose.

†Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

‡Dosing schedule for immunocompromised individuals 5 through 11 years of age for Pfizer-BioNTech COVID-19 Vaccines: Dose 1: Week 0; Dose 2: Week 3; Dose 3: ≥4 weeks after Dose 2. For individuals turning from 11 to 12 years of age during the vaccination series, complete the 3-dose series with 1 or 2 doses, as applicable, of COMIRNATY® (COVID-19 Vaccine, mRNA) (2024-2025 Formula) on or after the date the individual turns 12 years of age. If the individual turning 12 years of age receives 2 doses of COMIRNATY (COVID-19 Vaccine, mRNA) (2024-2025 Formula) to complete the vaccination series or receives a dose of COMIRNATY (COVID−19 Vaccine, mRNA) (2024-2025 Formula) less than 2 months after receipt of the last previous dose of COVID-19 vaccine to complete the vaccination series, then those uses of COMIRNATY (COVID-19 Vaccine, mRNA) (2024-2025 Formula) are authorized under EUA. The FDA has authorized under EUA these uses of COMIRNATY (COVID-19 Vaccine, mRNA) (2024-2025 Formula), which is an FDA-licensed vaccine indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. Refer to https://www.cvdvaccine.com for additional information about COMIRNATY (COVID-19 Vaccine, mRNA) (2024-2025 Formula).

§These prior COVID-19 vaccines are no longer authorized for use in the United States.

Reference

1. Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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.; August 22, 2024.

Ordering available through Pfizer Prime*

Orders for 2024-2025 formula COVID-19 vaccines by BioNTech and Pfizer can be placed by eligible
healthcare professionals directly with Pfizer through Pfizer Prime online or by calling 1-800-533-4535.

Visit Pfizer Prime

*Eligible healthcare providers can order COVID-19 vaccines directly from
Pfizer. If preferred, orders may be placed with your facility’s wholesaler.

IMPORTANT SAFETY INFORMATION

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AUTHORIZED USE

IMPORTANT SAFETY INFORMATION

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Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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 must be immediately available to manage potential anaphylactic reactions 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 (2024-2025 Formula) to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html. Vaccination providers administering COMIRNATY (COVID-19 Vaccine, mRNA) (2024-2025 Formula) under EUA must adhere to the same reporting requirements. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine (2024-2025 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 (2024-2025 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.

For more information

Pfizer Customer
Service

Including General Product Questions

Call 1-800-879-3477
Medical
Information
Visit PfizerMedicalInformation.com
Shipment Support
US Trade Customer Service
Call 1-800-666-7248

Pfizer Customer Service

Including General
Product Questions

Call 1-800-879-3477

Medical Information

Visit
PfizerMedicalInformation.com

Shipment Support US Trade Customer Service

Call 1-800-666-7248

Get COVID-19 Vaccine Text Updates Enroll in the BioNTech & Pfizer COVID Connect text messaging program for U.S. Healthcare Professionals.
Sign Up
Call a Pfizer Connect Representative Live representatives available 9 AM–5 PM ET to help HCPs answer product questions, discuss Pfizer Prime ordering, and more.
Call 1-844-966-5127

Emergency Use Authorization (EUA)

Emergency uses of COVID-19 vaccines from BioNTech and Pfizer, including Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula), 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. Emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical products 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 08/22/24

PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 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.

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula)

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 (2024-2025 Formula)”
  • Verify the cap color and label are for the respective authorized age group

Please see the Vaccine Presentation & Dosing Guide for more details.

Important Reminder:

Previous COVID-19 vaccines are no longer available 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.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials and cartons.

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

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