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HomeShelf Life & StoragePosology & Administration12 years and older5 to 11 years old Undesirable Effects12 years and older5 to 11 years old Efficacy12 years and older5 to 11 years oldResources
Dilute to use, 12 years and older Other Formulations
Shelf Life - Dilute to use, 12 years and older

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Storage Options - Dilute to use, 12 years and older
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​​​​​​​Store in the original package in order to protect from light.

PREFERRED

Ultra-Low-Temperature
(ULT) Freezer​​​​​​​

-90 °C to -60 °C

Can be stored up to

​​​​​​​9 months​​​​​​​

​​​​​​​Pfizer Thermal Shipping Container

-90 °C to -60 °C

Can be stored up to

30 days ​​​

at this temperature if consistently re-filled to the top of the container with dry ice*

​​​​​​​Freezer

-25 °C to -15 °C

Can be stored up to

2 weeks

​​​​​​​at this temperature within the 9-month shelf life and not past expiry date printed on the label

​​​​​​​Refrigerator

2 °C to 8 °C

Can be stored up to

​​​​​​​1 month 

​​​​​​​at this temperature within the 9-month shelf life and not past expiry date printed on the label


*Refer to the dry ice replenishment guidelines packed in the original thermal shipping container for instructions regarding the use of the thermal shipping container for temporary storage.

When stored frozen at -90 °C to -60 °C, 195‑vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.​​​Thawed vials can be handled in room light conditions.

Once thawed, the vaccine should be not re-frozen.



​​​​​​​​​​​​​​Transferring Between Environments  - Dilute to use, 12 years and older 
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Originating Temperature Environment

Maximum Time at Temperature up to 25 °C
During Storage or Transfer-
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Closed Vial Cartons

Maximum Time at Temperature up to 25 ​​​​​​​°C
During Storage or Transfer-
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Opened Vial Cartons

Time Required to Stay in Frozen Environment After Exposure up to 25 ​​​​​​​°C During Transfer
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Number of Times Vial Cartons May Be Transferred to the Preferred ULT Freezer Storage Condition​​​​​​​

From ULT Freezer
​​​​​​​-90 °C to -60 °C

OR

From Thermal Shipping Container*
​​​​​​​-90 °C to -60 °C

UP TO
5 minutes

UP TO
3 minutes

At least 2 hours before they can be removed again

N/A

From Freezer
-25 °C to -15 °C

UP TO
3 minutes

UP TO
1 minute**

No specified time before they can be taken out again

Limit ONE return to ULT Freezer; Total cumulative time the vials are stored at -25 °C to -15 °C should be tracked and should not exceed 2 weeks
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​​​​​​​*The thermal shipping container should not be opened for more than 3 minutes at a time.
**If possible, opened cartons should be left in the -25 ºC to -15 °C environment when removing vials for use. If the carton must be removed from the freezer, return to freezer in less than 1 minute.

Once a vial is removed from the vial tray, it should be thawed for use. 
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How to Handle Vaccine - Dilute to use, 12 years and older

Handling of temperature excursions onced removed from the freezer
Stability data indicate that the unopened vial is stable for up to:

  • 24 hours when stored at temperatures from -3 °C to 2 °C.
  • a total of 4 hours when stored at temperatures from 8 °C to 30 °C; this includes 2 hours at up to 30 °C.
This information is intended to guide healthcare professionals only in case of temporary temperature excursion.
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Special precautions for storage

  • Store in a freezer at -90 °C to -60 °C.
  • Store in the original package in order to protect from light.
  • During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
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Diluted medicinal product 
Chemical and physical in-use stability, including during transportation, has been demonstrated for 6 hours at 2 °C to 30 °C after dilution in sodium chloride 9 mg/mL (0.9%) solution for injection. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Other Formulations
For more information ​​​​​​​

[Country to insert: customer service contact information]

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH
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COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified), which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

 ​​​​​​​​​​©2021 Pfizer Inc. All rights reserved. December 2021. PP-CMR-GLB-0080​​​

SmPC Updates

Updates to General Recommendations and Undesirable Effects regarding Myocarditis and Pericarditis. Please see sections 4.4 and 4.8 of Summary of Product Characteristics for details. This update concerns all available formulations of COMIRNATY.

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