If COMIRNATY is received frozen at -90°C to -60°C the frozen vials can continue to be stored at -90°C to -60°C according to the table as follows. (See Table 40.)
Click on icon to see table/diagram/imageThawing frozen vials: Frozen (-90°C to -60°C) vials can be thawed at either 2°C to 8°C or at temperatures up to 30°C (see Special precautions for disposal and other handling under Cautions for Usage for more detailed thawing instructions).
Once thawed, the vaccine should not be re-frozen.
Shelf life of refrigerated vials: Frozen vials may be transferred to refrigerated storage (2°C to 8°C) upon receipt. Once moved to refrigerated storage, unopened vials may be stored for a single period of up to 10 weeks, not exceeding the original expiry date (EXP).
Upon moving the product to 2°C to 8°C storage, the original expiry date on the outer carton should be crossed out and updated expiry date must be written (10 weeks from the date the vials were removed from frozen storage). The vaccine should be used or discarded by the updated expiry date.
If the vaccine is received refrigerated (2°C to 8°C) it should be stored at 2°C to 8°C. Check that the expiry date on the outer carton has been updated to reflect the refrigerated expiry date and that the original expiry date has been crossed out.
Storage of thawed, opened (punctured or diluted) vials: Once a vial has been punctured or diluted (dilution with sodium chloride 9 mg/mL 0.9% solution for injection) chemical and physical in-use stability has been demonstrated for 12 hours at 2°C to 30°C.
From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used immediately after the first puncture of single dose vials and within 12 hours after puncture or dilution of multidose vials. If not used within the recommended duration, in-use storage times and conditions are the responsibility of the user.
Pre-filled syringes: Shelf life of unopened glass pre-filled syringes: 12 months when stored at 2°C to 8°C.
Verify the storage conditions on the pre-filled syringe label and apply the applicable storage conditions for that presentation.
COMIRNATY glass pre-filled syringes should not be frozen.
Syringes may be stored at temperatures between 8°C and 30°C for up to 12 hours.
Special precautions for storage: Store COMIRNATY in the original package in order to protect from light.
During use, thawed vials and pre-filled syringes can be handled in room light conditions. Avoid exposure to direct sunlight and ultraviolet light.
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