Vaccine Information: Moderna COVID-19 Vaccine

MODERNA COVID-19 VACCINE- cx-038839 omicron (xbb.1.5) injection, suspension
Moderna US, Inc.

HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA)

These highlights of the EUA do not include all the information needed to use Moderna COVID-19 Vaccine under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for Moderna COVID-19 Vaccine.Moderna COVID-19 VaccineSuspension for injection, for intramuscular use2023-2024 Formula Original EUA Authorized Date: 12/2020Most Recent EUA Authorized Date: 9/2023 ——————————– RECENT MAJOR CHANGES —————————— Dosage and Administration

Preparation for Administration (2.1) 9/2023
Dosing and Schedule (2.3) 9/2023

——————————– EMERGENCY USE AUTHORIZATION —————————— The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Moderna 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.See Full Fact Sheet for Healthcare Providers for the justification for emergency use of Moderna COVID-19 Vaccine (2023-2024 Formula), information on available alternatives, and additional information on COVID-19.——————————– DOSAGE AND ADMINISTRATION ——————————

For intramuscular injection only. (2)Individuals 6 Months Through 4 Years of Age by Moderna COVID-19 Vaccination Status (2.3)

Individuals with Certain Kinds of ImmunocompromiseIndividuals with certain kinds of immunocompromise 6 months through 11 years of age should complete at least a three-dose series with a COVID-19 vaccine, each dose one month apart. 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 FORMS AND STRENGTHS—————————— Moderna COVID-19 Vaccine is a suspension for injection.A single dose is 0.25 mL. (3)——————————CONTRAINDICATIONS————————————– History of a severe allergic reaction (e.g., anaphylaxis) to any component of Moderna COVID-19 Vaccine or following a previous dose of a Moderna COVID-19 vaccine. (4)——————————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 Moderna COVID-19 Vaccine, the observed risk is highest in males 18 years through 24 years of age. (5.2)——————————ADVERSE REACTIONS—————————— Solicited adverse reactions included:

6 months through 36 months of age: Injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness.
37 months through 11 years of age: Injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia and nausea/vomiting. (6.1)

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 Moderna 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. To the extent feasible, report adverse events to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762) or provide a copy of the VAERS form to ModernaTX, Inc. (https://report.moderna.convergehealthsafety.com/) (6.3)See FACT SHEET FOR RECIPIENTS AND CAREGIVERS

Number of Previous Doses of Moderna COVID-19 Vaccine(s)a

Moderna COVID-19 Vaccine

(2023-2024 Formula)

Dosing Regimen, Dose and Scheduleb

0c

2 doses,d 0.25 mL each

Dose 1: month 0

Dose 2: month 1

1

Single Dose, 0.25 mL

One month after receipt of a previous dose of Moderna COVID-19 vaccinea

≥2

Single dose, 0.25 mL

≥2 months after receipt of the last previous dose of Moderna COVID-19 vaccinea

a Previous dose(s) of Moderna COVID-19 vaccine(s) refers to Moderna COVID-19 Vaccine (Original monovalent) and Moderna 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 a Moderna COVID-19 vaccine, see text following the tables for dosing information.c Not previously vaccinated with any COVID-19 vaccine.d Individuals turning from 4 years to 5 years of age during the vaccination series should receive both doses with Moderna COVID-19 Vaccine (2023-2024 Formula).

Individuals 5 Years Through 11 Years of Age Irrespective of COVID-19 Vaccination Status (2.3)

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

Single dose, 0.25 mL If previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccinea,b

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

TABLE OF CONTENTS*

14 CLINICAL STUDIES

1 EMERGENCY USE AUTHORIZATION

14.1 Efficacy of Two-Dose Primary Series of Moderna COVID-19 (Original Monovalent) in Participants 18 Years of Age and Older

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

14.2 Effectiveness of Two-Dose Primary Series of Moderna COVID-19 Vaccine (Original Monovalent) in Participants 12 Years Through 17 Years of Age

2.2 Administration

2.3 Dose and Schedule

14.3 Effectiveness of Two-Dose Primary Series of Moderna COVID-19 Vaccine (Original Monovalent) in Participants 6 Years Through 11 Years of Age

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

14.4 Effectiveness of Two-Dose Primary Series of Moderna COVID-19 Vaccine (Original Monovalent) in Participants 6 Months Through 5 Years of Age

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

14.5 Immunogenicity of Moderna COVID-19 Vaccine (Original Monovalent) Booster Dose Following Moderna COVID-19 Vaccine (Original Monovalent) Primary Series in Participants 6 Years Through 11 Years of Age

5.2 Myocarditis and Pericarditis

5.3 Syncope

5.4 Altered Immunocompetence

14.6 Immunogenicity of Moderna COVID-19 Vaccine (Original Monovalent) Booster Dose Following Moderna COVID-19 Vaccine (Original Monovalent) Primary Series in Participants 17 Months Through 5 Years of Age

5.5 Limitations of Vaccine Effectiveness

6 ADVERSE REACTIONS

14.7 Immunogenicity of Moderna COVID-19 Vaccine Administered as a First Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

6.3 Required Reporting for Serious Adverse Events and Vaccine Administration Errors

14.8 Immunogenicity of Bivalent Vaccine (Original and Omicron BA.1) Administered as a Second Booster Dose in Participants 18 Years of Age and Older

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

14.9 Immunogenicity of a Single Dose of Moderna COVID-19 Vaccine (Original Monovalent) in Participants 6 Years of Age and Older with Evidence of Prior SARS-CoV-2 Infection

8.1 Pregnancy

8.2 Lactation

16 HOW SUPPLIED/STORAGE AND HANDLING

8.4 Pediatric Use

8.6 Use in Immunocompromised Individuals

17 PATIENT COUNSELING INFORMATION

11 DESCRIPTION

18 MANUFACTURER INFORMATION

12 CLINICAL PHARMACOLOGY

* Sections or subsections omitted from the EUA are not listed

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