Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine

PFIZER-BIONTECH COVID-19 VACCINE- raxtozinameran injection, suspension
Pfizer Manufacturing Belgium NV

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE: EMERGENCY USE AUTHORIZATION OF PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA), FOR 6 MONTHS THROUGH 11 YEARS OF AGE

HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA)

These highlights of the EUA do not include all the information needed to use Pfizer-BioNTech COVID-19 Vaccine under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for Pfizer-BioNTech COVID-19 Vaccine.Pfizer-BioNTech COVID-19 Vaccine suspension for injection, for intramuscular use.2023-2024 FormulaOriginal EUA Authorized Date: 12/2020

Most Recent EUA Authorized Date: 9/2023 ——–RECENT MAJOR CHANGES ——–Dosage and Administration, Preparation for Administration (2.1) 9/2023Dosage and Administration, Administration (2.2) 9/2023Dosage and Administration, Dose and Schedule (2.3) 9/2023

Dosage Forms and Strengths (3) 9/2023

Individuals 5 Years Through 11 years of Age Irrespective of COVID-19 Vaccination Status

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)

Vial Cap and Label Border Color

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Dosing Regimen, Dose and Schedulea

Blue

Single dose, 0.3 mLIf previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccineb

——–EMERGENCY USE AUTHORIZATION ——–The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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. (1)The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), which is supplied in multiple dose vials with yellow caps and labels with yellow borders and in single dose vials with blue caps and labels with blue borders, is not licensed for any use. (1)See Full Fact Sheet for Healthcare Providers for the justification for emergency use of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), information on available alternatives, and additional information on COVID-19.

a. For individuals with certain kinds of immunocompromise, see text below tables for dosing information.

b. COVID-19 vaccine refers to the monovalent COVID-19 vaccines that encode the spike protein of the original SARS-CoV-2 and the bivalent COVID-19 vaccines encoding the spike protein of original SARS-CoV-2 and of the Omicron variant lineages BA.4 and BA.5 that are no longer authorized for use in the United States.

Individuals with Certain Kinds of Immunocompromise

Individuals 6 months 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 (2023-2024 Formula).

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. (2.3)

——–DOSAGE AND ADMINISTRATION ——–For intramuscular injection only. (2)

——–DOSAGE FORMS AND STRENGTHS——– Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. A single dose is 0.3 mL. (3)

Individuals 6 Months Through 4 Years of Age by Pfizer-BioNTech COVID-19 Vaccination Status

——–CONTRAINDICATIONS——– History of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or following a previous dose of a Pfizer-BioNTech COVID-19 vaccine. (4)

Number of Previous Doses of Pfizer-BioNTech COVID-19 vaccine(s)a

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)

Vial Cap and Label Border Color

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)

Dosing Regimen, Dose and Scheduleb

——–WARNINGS AND PRECAUTIONS——-

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. (5.2)

0c

Yellow

3 dosesd , 0.3 mL each

Dose 1: Week 0

Dose 2: Week 3

Dose 3: ≥8 weeks after Dose 2

——–ADVERSE REACTIONS——– Solicited adverse reactions included:

6 months through 23 months of age: Injection site redness; swelling and tenderness; decreased appetite; drowsiness; fever; irritability. (6.1)
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. (6.1)

1

Yellow

2 dosesd , 0.3 mL each

Dose 1: 3 weeks after receipt of the previous dose of Pfizer-BioNTech COVID-19 vaccinea

Dose 2: ≥8 weeks after Dose 1

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/(6.3)See FACT SHEET FOR RECIPIENTS AND CAREGIVERS.

2 to 4

Yellow

Single dose, 0.3 mL

≥8 weeks after receipt of the last previous dose of Pfizer-BioNTech COVID-19 vaccinea

a. Previous doses of Pfizer-BioNTech COVID-19 vaccine(s) refers to doses with Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). These vaccines are no longer authorized for use in the United States.

b. For individuals with certain kinds of immunocompromise previously vaccinated with Pfizer-BioNTech COVID-19 vaccines, see text below tables for dosing information.

c. Not previously vaccinated with any COVID-19 vaccine.

d. 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.

TABLE OF CONTENTS*

1.
EMERGENCY USE AUTHORIZATION
2.
DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
2.2 Administration
2.3 Dose and Schedule
3.
DOSAGE FORMS AND STRENGTHS
4.
CONTRAINDICATIONS
5.
WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
5.2 Myocarditis and Pericarditis
5.3 Syncope
5.4 Altered Immunocompetence
5.5 Limitations of Vaccine Effectiveness
6.
ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
6.3 Required Reporting for Adverse Events and Vaccine Administration Errors
7.
DRUG INTERACTIONS
8.
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.6 Use in Immunocompromised Individuals
11.
DESCRIPTION
12.
CLINICAL PHARMACOLOGY
14.
CLINICAL STUDIES
14.1 Efficacy of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 16 Years of Age and Older
14.2 Efficacy of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 12 Through 15 Years of Age
14.3 Efficacy of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 5 Through 11 Years of Age
14.4 Immunogenicity of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 5 Through 11 Years of Age
14.5 Effectiveness of 3-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Participants 6 Months Through 4 Years of Age
14.6 Immunogenicity of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) Booster Dose Following Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) Primary Series in Participants 5 Through 11 Years of Age
14.7 Immunogenicity of a Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine (Original Monovalent)
14.8 Immunogenicity of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Administered as a Booster (Fourth Dose) in Individuals 6 Months Through 4 Years of Age
14.9 Effectiveness of a Single Dose of Pfizer-BioNTech COVID-19 Vaccine (Original Monovalent) in Individuals with Evidence of Prior SARS-CoV-2 Infection
16.
HOW SUPPLIED/STORAGE AND HANDLING
17.
PATIENT COUNSELING INFORMATION
18.
MANUFACTURER INFORMATION

* Sections or subsections omitted from the EUA are not listed

FULL FACT SHEET FOR HEALTHCARE PROVIDERS

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