Vaccine Information: Moderna COVID-19 Vaccine, Bivalent (Page 3 of 11)

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 Bivalent, 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 Moderna COVID-19 Vaccine, Bivalent may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

This EUA for Moderna COVID-19 Vaccine, Bivalent 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: Oct/12/2022

END SHORT VERSION FACT SHEET

Long Version (Full EUA Prescribing Information) Begins On Next Page

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)

FULL EUA PRESCRIBING INFORMATION: CONTENTS*

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA 18.1 Efficacy of Two-Dose Primary Series of Moderna COVID-19 Vaccine in Participants 18 Years and Older

18.2 Effectiveness of Two-Dose Primary Series in Adolescents 12 Years Through 17 Years of Age

18.3 Effectiveness of Two-Dose Primary Series in Individuals 6 Years Through 11 Years of Age

18.4 Immunogenicity of the Bivalent Vaccine (Original and Omicron BA.1) Administered as a Second Booster Dose

18.5 Immunogenicity of Moderna COVID-19 Vaccine Administered as a First Booster Dose Following a Primary Series of Moderna COVID-19 Vaccine in Participants 18 Years and Older

18.6 Immunogenicity of Moderna COVID-19 Vaccine Booster Dose Following Moderna COVID-19 Vaccine Primary Series in Participants 12 Years Through 17 Years of Age

18.7 Immunogenicity of Moderna COVID-19 Vaccine Booster Dose Following Moderna COVID-19 Vaccine Primary Series in Participants 6 Years Through 11 Years of Age

18.8 Immunogenicity of Moderna COVID-19 Vaccine Administered as a First Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine19 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

11 USE IN SPECIFIC POPULATIONS 11.1 Pregnancy11.2 Lactation11.3 Pediatric Use11.4 Geriatric Use13 DESCRIPTION14 CLINICAL PHARMACOLOGY 14.1 Mechanism of Action

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 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 years of age and older.

This EUA Prescribing Information pertains only to Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Moderna COVID-19 Vaccine, Bivalent.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

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

2.1 Preparation for Administration

Moderna COVID-19 Vaccine, Bivalent is supplied as a frozen suspension that does not contain a preservative and must be thawed prior to administration.
Verify that the vial label states Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).
Thaw each vial before use following the instructions below.

Thawing Instructions for Moderna COVID-19 Vaccine, Bivalent

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.
Moderna COVID-19 Vaccine, Bivalent 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.
A booster dose for individuals 12 years of age and older is 0.5 mL.
A booster dose for individuals 6 years through 11 years of age is 0.25 mL.
If withdrawing only 0.5 mL doses, each multiple-dose vial contains 5 booster doses.
If withdrawing only 0.25 mL doses, each multiple-dose vial contains 10 booster doses.
Both 0.5 mL doses and 0.25 mL doses may be withdrawn from the same multiple-dose vial.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL or 0.25 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
After the first booster 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, Bivalent vial label. Discard vial after 12 hours. Do not refreeze.

2.2 Administration

Administer Moderna COVID-19 Vaccine, Bivalent intramuscularly.

2.3 Dosing and Schedule

A single booster dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

For individuals 12 years of age and older, a single booster dose is 0.5 mL.
For individuals 6 years through 11 years of age, a single booster dose is 0.25 mL.

3 DOSAGE FORMS AND STRENGTHS

Moderna COVID-19 Vaccine, Bivalent is a suspension for injection supplied in a multiple-dose vial with a dark blue cap and a label with a gray border.

Each booster dose for individuals 12 years and older is 0.5 mL.
Each booster dose for individuals 6 years through 11 years is 0.25 mL.

4 CONTRAINDICATIONS

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

Monitor Moderna COVID-19 Vaccine, Bivalent 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 safety data with Moderna COVID-19 Vaccine are relevant to Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For the Moderna COVID-19 Vaccine, 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.

Some, but not all, observational analyses of postmarketing data suggest that there may be an increased risk of myocarditis and pericarditis in males under 40 years of age following the second dose of Moderna COVID-19 Vaccine primary series relative to other authorized or approved 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).

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