Comirnaty (COVID-19 Vaccine, mRNA) 11 Storage, Stability And Disposal

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During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Do not refreeze thawed vials.

For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border)

Frozen Vials Prior to Use
Cartons of COMIRNATY multiple dose vials (for 12 years and older: DILUTE BEFORE USE) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the COMIRNATY Shipping and Handling Guidelines available at COMIRNATY.ca. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between ‑90°C to -60°C (-130°F to -76°F) until the expiry date printed on the label. Vials may also be stored at -25°C to -15°C (‑13°F to 5°F) for up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Vials stored at -25°C to ‑15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -90°C to -60°C (-130°F to -76°F). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks.

If an ultra-low temperature freezer is not available, the thermal container in which COMIRNATY arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90°C to -60°C (‑130°F to -76°F). Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an excursion from the recommended storage condition.

Transportation of Frozen Vials
If local redistribution is needed and full cartons containing vials cannot be transported at ‑90°C to ‑60°C (‑130°F to ‑76°F), vials may be transported at -25°C to ‑15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to 5°F) count against the 2‑week limit for storage at -25°C to -15°C (-13°F to 5°F). Frozen vials transported at -25°C to -15°C (‑13°F to 5°F) may be returned one time to the recommended storage condition of -90°C to -60°C (-130°F to -76°F).

Thawed Vials Prior to Dilution

Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2°C to 8°C [35°F to 46°F]) for up to 1 month. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. 

Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25°C (77°F)] for 30 minutes.

Thawed vials can be handled in room light conditions.

Vials must reach room temperature before dilution. 

Undiluted vials may be stored at room temperature for no more than 2 hours.

Transportation of Thawed Vials
Available data support transportation of one or more thawed, undiluted vials at 2°C to 8°C (35°F to 46°F) for up to 12 hours. Any hours used for transport at 2°C to 8°C (35°F to 46°F) count against the 1-month limit for storage at 2°C to 8°C (35°F to 46°F).

Vials After Dilution
After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. Any vaccine remaining in vials must be discarded after 6 hours. After dilution, the vaccine vials can be handled in room light conditions. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not freeze. If the vaccine is frozen, it must be discarded.

For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border)

Vial Storage Prior to Use

Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultra cold conditions in thermal containers with dry ice. 

Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for a single period of up to 10 weeks within the 12-month shelf-life. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.

Alternatively, frozen vials may be stored in an ultra-low temperature freezer at  90°C to  60°C ( 130°F to  76°F). Do not store vials at  25°C to  15°C (-13°F to 5°F). Once vials are thawed they should not be refrozen.

Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2°C to 8°C. If received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

Regardless of storage condition, vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. 

Vial Storage During Use

If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.

COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25°C (77°F) for a total of 12 hours prior to the first puncture. 

DO NOT DILUTE PRIOR TO USE.

After first puncture, the vial should be stored at 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons.

Thawed vials can be handled in room light conditions. 

Transportation of Vials

If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90°C to -60°C (-130°F to -76°F); full cartons or individual unpunctured vials may also be transported at 2°C to 8°C (35°F to 46°F).

For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border)

And

For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border)

Vial Storage Prior to Use

Cartons of COMIRNATY multiple dose vials (for age 5 years to <12 years) and COMIRNATY multiple dose vials (for age 6 months to <5 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice.

Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for a single period of up to 10 weeks within the 12-month shelf-life. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer.  

  • COMIRNATY (for age 5 years to <12 years): A carton of 10 vials may take up to 4 hours to thaw at this temperature.
  • COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature.

Alternatively, frozen vials may be stored in an ultra-low temperature freezer at  90°C to  60°C ( 130°F to  76°F) for up to 12 months from the date of manufacture. Do not store vials at  25°C to  15°C (-13°F to 5°F). Once vials are thawed they should not be refrozen. 

Cartons of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may also arrive at 2°C to 8°C (35°F to 46°F). If vials are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons.

Vial Storage During Use

If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.

Vials of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may be stored at temperatures up to 25°C (77°F) for a total of 12 hours prior to dilution.

After dilution the vials should be stored at 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution (i.e., the first puncture). Vial labels and cartons may state that a vial should be discarded 6 hours after dilution. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons.

Thawed vials can be handled in room light conditions.

Transportation of Vials

If local redistribution is needed, full cartons containing undiluted vials may be transported at ‑90°C to ‑60°C (‑130°F to ‑76°F); full cartons or individual undiluted vials may also be transported at 2°C to 8°C (35°F to 46°F).