Efficacy

This site is intended for U.S. Healthcare Professionals.

Authorized Use
Report Adverse Event
Report Adverse Event to VAERS
Report Adverse Event to Pfizer
EUA Letter
EUA Fact Sheets
Vaccination
Providers (English)
Vaccination Providers
(Spanish)
Recipients and
Caregivers
(English)
Recipients and Caregivers (Spanish)
Vaccine Finder Order on Pfizer Prime Visit Approved Vaccine Option for 12+ Years of Age
Authorized Use Order on Pfizer Prime

Select Clinical Trial Data Evaluating Pfizer-BioNTech COVID-19 Vaccine1

The effectiveness of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age is based on:

  • Effectiveness of Pfizer-BioNTech COVID-19 Vaccine (Original monovalent)* in individuals 6 months of age and older, and
  • Immunogenicity of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)* in individuals 6 months through 4 years of age

*These vaccines are no longer authorized for use in the United States.

Clinical Studies (EUA Fact Sheet, Section 14)

Clinical Trials Experience (EUA Fact Sheet, Section 6.1)

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.

IMPORTANT SAFETY INFORMATION

Expand

Collapse

AUTHORIZED USE

IMPORTANT SAFETY INFORMATION

Expand

Collapse

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 from use of authorized or approved mRNA COVID-19 vaccines, including Pfizer-BioNTech COVID-19 Vaccine, have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.

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.

July 2025 PP-CVV-USA-5261

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.

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

July 2025 PP-CVV-USA-5261

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

Scroll to view an
Important Safety Update

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.

July 2025 PP-CVV-USA-5290

Scroll to view an Important Safety Update

Update to Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) Prescribing Information as of June 25, 2025

A change was made to the Warnings and Precautions regarding Myocarditis and Pericarditis.

Myocarditis and Pericarditis

Postmarketing data from use of authorized or approved mRNA COVID-19 vaccines, including Pfizer-BioNTech COVID-19 Vaccine, have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.

Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA
COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.

Although some individuals with myocarditis and/or pericarditis following administration of mRNA COVID-19 vaccines have required intensive care support, available data suggest that individuals typically have resolution of symptoms within a few days with conservative management.

Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known [see Adverse Reactions (6.2)].

Information is not yet available about potential long-term sequelae of myocarditis or pericarditis following administration of mRNA COVID-19 vaccines. 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).

July 2025 PP-CVV-USA-5290

Close