Vaccine Information: NOVAVAX COVID-19 Vaccine, Adjuvanted (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80631-100-10 novavax

Novavax COVID-19 Vaccine,
Adjuvanted

Suspension for Intramuscular Injection

10 Multi-Dose VialsEach vial contains 10 doses of 0.5 mL

For use under Emergency Use Authorization

NDC 80631-100-01

Novavax COVID-19 Vaccine, Adjuvanted

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

For use under Emergency Use
Authorization. Store at 2 to 8°C
(36 to 46°F). DO NOT FREEZE.
After first puncture, hold at 2 to 25°C
(36 to 77°F). Discard after 12 hours.
No Preservative. Protect from light.

20018470/1

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

NDC 80631-102-10 novavax

Novavax COVID-19 Vaccine, Adjuvanted

Suspension for Intramuscular Injection

10 Multi-Dose VialsEach vial contains 5 doses of 0.5 mL

For use under Emergency Use Authorization

NDC 80631-102-01

Novavax COVID-19 Vaccine, Adjuvanted

Suspension for Intramuscular Injection
Multi-dose vial (5 doses of 0.5mL)

For use under Emergency Use
Authorization. Store at 2 to 8°C
(36 to 46°F). DO NOT FREEZE.
After first puncture, hold at 2 to 25°C
(36 to 77°F). Discard after 12 hours.
No Preservative. Protect from light.

20018984/1

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

NDC 80631-105-02 novavax

Novavax COVID-19 Vaccine, Adjuvanted

2023-2024 Formula

Suspension for Intramuscular Injection

2 multi-dose vialsEach vial contains 5 doses of 0.5 mL

For 12 years of age and older

For use under Emergency Use Authorization

Rx Only

NDC 80631-105-01

Novavax COVID-19 Vaccine, Adjuvanted

2023-2024 Formula

Multi-dose vial (5 doses of 0.5mL)

For IM use. For use under Emergency
Use Authorization. Store at 2 to 8°C
(36 to 46°F). DO NOT FREEZE.
After first puncture, hold at 2 to 25°C
(36 to 77°F). Discard after 12 hours.No Preservative. Protect from light.

Product of India

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

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 EGG PHOSPHOLIPIDS

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

NOVAVAX COVID-19 VACCINE, ADJUVANTED nvx-cov2373 injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:80631-102 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 EGG PHOSPHOLIPIDS

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:80631-102-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (80631-102-01) 1 NDC:80631-102-01 2.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (80631-102-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date emergency use authorization 02/01/2023

NOVAVAX COVID-19 VACCINE, ADJUVANTED nvx-cov2373 injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:80631-105 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 EGG PHOSPHOLIPIDS

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:80631-105-02 2 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (80631-105-01) 1 NDC:80631-105-01 2.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (80631-105-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date emergency use authorization 08/01/2023

Labeler — Novavax, Inc. (808837520)

Revised: 08/2023 Novavax, Inc.