MODERNA COVID-19 VACCINE, BIVALENT- moderna covid-19 vaccine, bivalent injection, suspension
Moderna US, Inc.

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DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Information for Patients

Laboratory Tests

Interactions

Drug Interactions

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

Controlled Substance

Abuse

Dependence

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Package/Label Display Panel

NDC 80777-283-02

Moderna COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

BOOSTER DOSES ONLY

Age 6m through 5y

For IM Use. For use under EUA.

Vial contains 2 doses of 0.2 mL

Scan carton QR code for expiry date

Package/Label Display Panel

NDC 80777-283-99

Moderna COVID-19 Vaccine, Bivalent

Suspension for Intramuscular Injection

Original and Omicron BA.4/BA.5

For use under Emergency Use Authorization

BOOSTER DOSES ONLY

For age 6 months through 5 years

STORE FROZEN between -50° to -15°C (-58° to 5°F).

Protect from light

Ten multi-dose vials

Each vial contains 2 doses of 0.2 mL

MODERNA COVID-19 VACCINE, BIVALENT
moderna covid-19 vaccine, bivalent injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC:80777-283
Route of Administration	INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ELASOMERAN (UNII: EPK39PL4R4) (ELASOMERAN - UNII:EPK39PL4R4)	ELASOMERAN	5 ug in 0.2 mL
CX-034476 OMICRON (BA.4/BA.5) (UNII: TYF7YW7ENF) (CX-034476 OMICRON (BA.4/BA.5) - UNII:TYF7YW7ENF)	CX-034476 OMICRON (BA.4/BA.5)	5 ug in 0.2 mL

Ingredient Name	Strength
Inactive Ingredients
SM-102 (UNII: T7OBQ65G2I)
CHOLESTEROL (UNII: 97C5T2UQ7J)
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)
1,2-DIMYRISTOYL-RAC-GLYCERO-3-METHOXYPOLYETHYLENE GLYCOL 2000 (UNII: 9X2596CIE0)
TROMETHAMINE (UNII: 023C2WHX2V)
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)
ACETIC ACID (UNII: Q40Q9N063P)
SODIUM ACETATE (UNII: 4550K0SC9B)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:80777-283-99	10 in 1 CARTON
1	NDC:80777-283-02	0.4 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Emergency Use Authorization		09/23/2022

Labeler - Moderna US, Inc. (117626450)

Name	Address	ID/FEI	Business Operations
Establishment
ModernaTX, Inc.		116912313	ANALYSIS(80777-283) , API MANUFACTURE(80777-283)

Name	Address	ID/FEI	Business Operations
Establishment
Catalent Indiana, LLC		172209277	MANUFACTURE(80777-283) , ANALYSIS(80777-283) , LABEL(80777-283) , PACK(80777-283)

Revised: 9/2022

Document Id: 04c2d0f3-6209-4ae8-823c-842d0881b61b

Set id: 04c2d0f3-6209-4ae8-823c-842d0881b61b

Version: 1

Effective Time: 20220923

Moderna US, Inc.