Vaccine Information: NOVAVAX COVID-19 Vaccine, Adjuvanted

NOVAVAX COVID-19 VACCINE, ADJUVANTED- sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 injection, suspension
Novavax, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80631-100-10 novavax

10 Multi-Dose Vials

(10 doses of 0.5mL)

novavax COVID-19 Vaccine, Adjuvanted

Suspension for
Intramuscular Injection

For use under Emergency Use Authorization

NOVAVAX-1
(click image for full-size original)

novavax NDC 80631-100-01

COVID-19 Vaccine, Adjuvanted

Suspension for Intramuscular Injection Multi-dose vial (10 doses of 0.5mL)

Record date/time of first
puncture:

No Preservative

Date: Time:

For use under Emergency Use Authorization
See FDA-authorized Fact Sheet for dosage and
administration. Store at 2 to 8ºC (36 to 46ºF)
DO NOT FREEZE. Discard 6 hours after first
puncture when stored at 2 to 25°C (36 to 77°F)
Keep the vial in carton to protect from light
EXP: See www.NovavaxCovidVaccine.com

Manufactured for: Novavax, Inc., Gaithersburg, MD 20878

xxxxxx-xxx GTIN 0123456789

novavax

NOVAVAX-2
(click image for full-size original)
NOVAVAX COVID-19 VACCINE, ADJUVANTED
nvx-cov2373 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:80631-100
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 (SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373) SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
CHOLESTEROL
MONOBASIC POTASSIUM PHOSPHATE
POTASSIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM CHLORIDE
POLYSORBATE 80
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80631-100-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (80631-100-01)
1 NDC:80631-100-01 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (80631-100-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
emergency use authorization 01/31/2022
Labeler — Novavax, Inc. (808837520)

Revised: 03/2022 Novavax, Inc.

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