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

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

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.