COMIRNATY▼ COVID-19 mRNA Vaccine (tozinameran)

The Summary of Product Characteristics for Comirnaty  for use in children aged 5-11 years (10 μg/dose; Orange cap) states the following: 

6.3 Shelf life

Unopened vial

Frozen vial

12 months when stored at -90 °C to -60 °C.

The vaccine will be received frozen at ‑90 °C to ‑60 °C. Frozen vaccine can be stored either at ‑90 °C to ‑60 °C or 2 °C to 8 °C upon receipt.

When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 4 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Thawed vial

10 weeks storage and transportation at 2 °C to 8 °C within the 12-month shelf life.

• Upon moving the vaccine to 2 °C to 8 °C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be crossed out.
• If the vaccine is received at 2 °C to 8 °C it should be stored at 2 °C to 8 °C. The expiry date on the outer carton should have been updated to reflect the refrigerated expiry date and the original expiry date should have been crossed out.

Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C.

Thawed vials can be handled in room light conditions.

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

Handling of temperature excursions during refrigerated storage

• Stability data indicate that the unopened vial is stable for up to 10 weeks when stored at temperatures from -2 °C to 2 °C, and within the 10 weeks storage period between 2 °C and 8 °C.
• Stability data indicate the vial can be stored for up to 24 hours at temperatures of 8 °C to 30 °C, including up to 12 hours following first puncture.

This information is intended to guide healthcare professionals only in case of temporary temperature excursion.

Diluted medicinal product

Chemical and physical in-use stability has been demonstrated for 12 hours at 2 °C to 30 °C, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, which includes up to 6 hours transportation time. 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.

6.4 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.

This information can also be found in the Comirnaty (COVID-19 mRNA Vaccine Summary of Product Characteristics. For more information on handling instructions, please refer to section 6.6 Special precautions for disposal and other handling.

Alternatively, for further information, please submit your inquiry through our web form or other contact methods.