NOVAVAX COVID-19 VACCINE, ADJUVANTED- nvx-cov2705 injection, suspension

NOVAVAX COVID-19 Vaccine, Adjuvanted by

Drug Labeling and Warnings

NOVAVAX COVID-19 Vaccine, Adjuvanted by is a Other medication manufactured, distributed, or labeled by Novavax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

1 EMERGENCY USE AUTHORIZATION

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

14 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

18 MANUFACTURER INFORMATION

PRINCIPAL DISPLAY PANEL – Novavax COVID-19 Vaccine, Adjuvanted - Syringe Label

NDC 80631-107-01

Rx Only

Novavax COVID-19 Vaccine, Adjuvanted

2024-2025 Formula

Suspension for Intramuscular Injection

For use under Emergency Use Authorization

PRINCIPAL DISPLAY PANEL – Novavax COVID-19 Vaccine, Adjuvanted - Carton

NDC 80631-107-10

novavax

Novavax COVID-19 Vaccine, Adjuvanted

2024-2025 Formula

Suspension for Intramuscular Injection

10 single-dose pre-filled syringes

Each syringe contains 1 dose of 0.5 mL

Needles not included

For 12 years of age and older

For use under Emergency Use Authorization

Rx Only

INGREDIENTS AND APPEARANCE

NOVAVAX COVID-19 VACCINE, ADJUVANTED 
nvx-cov2705 injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 80631-107
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NVX-CoV2705 (UNII: 2RLB4T4GW2) (NVX-CoV2705 - UNII:2RLB4T4GW2)	NVX-CoV2705	5 ug  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
CHOLESTEROL (UNII: 97C5T2UQ7J)
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80631-107-10	10 in 1 CARTON
1	NDC: 80631-107-01	0.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/23/2024

Labeler - Novavax, Inc. (808837520)