Vaccine Information: Moderna COVID-19 Vaccine (Page 3 of 8)

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 Pandemic. In response, the FDA has issued an EUA for the unapproved product, Moderna COVID-19 Vaccine, for active immunization to prevent COVID-19.

FDA issued this EUA, based on ModernaTX, Inc.’s request and submitted data.

For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Moderna COVID-19 Vaccine may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

This EUA for the Moderna COVID-19 Vaccine will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

For additional information about Emergency Use Authorization, visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy- framework/emergency-use-authorization.

COUNTERMEASURES INJURY COMPENSATION PROGRAM

The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP regarding the vaccines to prevent COVID-19, visit http://www.hrsa.gov/cicp, email cicp@hrsa.gov, or call: 1-855-266-2427.
Moderna US, Inc.
Cambridge, MA 02139
©2022 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patents
Revised: Aug/31/2022

END SHORT VERSION FACT SHEETLong Version (Full EUA Prescribing Information) Begins On Next Page

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS*

11 USE IN SPECIFIC POPULATIONS 11.1 Pregnancy11.2 Lactation11.3 Pediatric Use11.4 Use in Immunocompromised Individuals13 DESCRIPTION14 CLINICAL PHARMACOLOGY 14.1 Mechanism of Action18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA 18.1 Efficacy of Two-Dose Primary Series in Participants 18 Years and Older 18.2 Effectiveness of Two-Dose Primary Series in Individuals 6 Years Through 11 Years of Age18.3 Immunogenicity in Solid Organ Transplant Recipients19 HOW SUPPLIED/STORAGE AND HANDLING20 PATIENT COUNSELING INFORMATION21 CONTACT INFORMATION *Sections or subsections omitted from the full prescribing information are not listed

1 AUTHORIZED USE

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

2.2 Administration

2.3 Dosing 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 OVERALL SAFETY SUMMARY

6.1 Clinical Trials Experience

6.2 Post-Authorization Experience

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS

10 DRUG INTERACTIONS

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Moderna COVID-19 Vaccine 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 of age and older.

This EUA Prescribing Information pertains only to Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border, which are authorized for use in individuals 6 years through 11 years of age.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

The storage, preparation, and administration information in this EUA Prescribing Information apply to the Moderna COVID-19 Vaccine for individuals 6 years through 11 years of age, which is supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and in a multiple-dose vial with a dark blue cap and a label with a teal border.

2.1 Preparation for Administration

The Moderna COVID-19 Vaccine multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine multiple dose-vial with a dark blue cap and a label with a teal border contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.
Verify that the vial of Moderna COVID-19 Vaccine has a dark blue cap and a label with a purple border or a dark blue cap and a label with a teal border.
Thaw each vial before use following the instructions below.

Thawing Instructions for Moderna COVID-19 Vaccine Multiple-Dose Vials with Dark Blue Caps and Labels with a Purple Border or Multiple-Dose Vials with Dark Blue Caps and Labels with a Teal Border

Thaw in Refrigerator

Thaw at Room Temperature

Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours. Let each vial stand at room temperature for 15 minutes before administering.

Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 45 minutes.

After thawing, do not refreeze.
Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particulates. Do not administer if vaccine is discolored or contains other particulate matter.
Each multiple-dose vial with a dark blue cap and a label with a purple border and each multiple-dose vial with a dark blue cap and a label with a teal border contains 5 doses of 0.5 mL.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
After the first 0.5 mL dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F). Record the date and time of first use on the Moderna COVID-19 Vaccine vial label. Discard vial after 12 hours. Do not refreeze.

2.2 Administration

Administer the Moderna COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule

The Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border is administered as a primary series of two doses (0.5 mL each) 1 month apart to individuals 6 years through 11 years of age.

A third primary series dose (0.5 mL) of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border is authorized for administration at least 1 month following the second dose to individuals 6 years through 11 years of age with certain kinds of immunocompromise.

3 DOSAGE FORMS AND STRENGTHS

Moderna COVID-19 Vaccine is a suspension for injection. Each dose of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a purple border and in a multiple-dose vial with a dark blue cap and a label with a teal border for individuals 6 years through 11 years of age is 0.5 mL.

4 CONTRAINDICATIONS

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine [see Description (13)].

5 WARNINGS AND PRECAUTIONS

5.1 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 the Moderna COVID-19 Vaccine.

Monitor Moderna 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).

5.2 Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is highest in males 18 through 24 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).

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