Moderna COVID-19 Vaccine, Bivalent: Package Insert and Label Information

MODERNA COVID-19 VACCINE, BIVALENT- elasomeran and cx-034476 omicron (ba.4/ba.5) injection, suspension
Moderna US, Inc.

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

Moderna COVID-19 Vaccine, Bivalent Suspension for Intramuscular Injection for use under Emergency Use Authorization-Booster Doses Only-Multi-Dose Vial (0.5 mL or 0.25 mL based on age)
(click image for full-size original)

NDC 80777-282-05

Moderna COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

BOOSTER DOSES ONLY

Multi-Dose Vial

Booster dose: 0.5 mL or 0.25 mL based on age

Package/Label Display Panel

Moderna COVID-19 Vaccine, Bivalent Suspension for Intramuscular Injection for use under Emergency Use Authorization-Booster Doses Only-Carton (0.5 mL or 0.25 mL based on age)
(click image for full-size original)

NDC 80777-282-99

Moderna COVID-19 Vaccine, Bivalent

Original and Omicron BA.4/BA.5

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

BOOSTER DOSES ONLY

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

Protect from light

Ten multi-dose vials each containing 2.5 mL

Booster dose: 0.5 mL or 0.25 mL based on age

MODERNA COVID-19 VACCINE, BIVALENT
moderna covid-19 vaccine, bivalent injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:80777-282
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELASOMERAN (ELASOMERAN) ELASOMERAN 25 ug in 0.5 mL
CX-034476 OMICRON (BA.4/BA.5) (CX-034476 OMICRON (BA.4/BA.5)) CX-034476 OMICRON (BA.4/BA.5) 25 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SM-102
CHOLESTEROL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE
1,2-DIMYRISTOYL-RAC-GLYCERO-3-METHOXYPOLYETHYLENE GLYCOL 2000
TROMETHAMINE
TROMETHAMINE HYDROCHLORIDE
ACETIC ACID
SODIUM ACETATE
SUCROSE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80777-282-99 10 VIAL in 1 CARTON contains a VIAL (80777-282-05)
1 NDC:80777-282-05 2.5 mL in 1 VIAL This package is contained within the CARTON (80777-282-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 07/28/2022
Labeler — Moderna US, Inc. (117626450)
Establishment
Name Address ID/FEI Operations
ModernaTX, Inc. 116912313 ANALYSIS, API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Catalent Indiana, LLC 172209277 MANUFACTURE, ANALYSIS, LABEL, PACK
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services, LLC 079415560 MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 07/2022 Moderna US, Inc.

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