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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

COMIRNATY is a suspension for intramuscular injection and is supplied as follows:

Glass Prefilled Syringes
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Carton of 10 single dose prefilled syringes: NDC 0069-2432-10
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Single dose prefilled syringe: NDC 0069-2432-01
Vials
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Carton of 10 single dose vials: NDC 0069-2403-10
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Single dose vial: NDC 0069-2403-01

Regardless of presentation, during storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials, prefilled syringes, and cartons.

Storage Prior to Use

Glass Prefilled Syringes

Store COMIRNATY glass prefilled syringes refrigerated at 2°C to 8°C (35°F to 46°F). DO NOT FREEZE.

The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed 12 hours.

Single Dose Vials

COMIRNATY single dose vials may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Once received, frozen vials may be immediately transferred to the refrigerator at 2ºC to 8ºC (35ºF to 46ºF), thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. Cartons of 10 single dose vials may take up to 2 hours to thaw at this temperature. Once thawed, they should not be refrozen.

Alternatively, single dose vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F).

Cartons of COMIRNATY single dose vials may be received at 2°C to 8°C (35ºF to 46ºF), and they should be stored at 2°C to 8°C (35ºF to 46ºF). Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date.

The total time out of refrigeration (at temperatures between 8°C and 25°C (46°F and 77°F)) must not exceed 12 hours.

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