Imvamune: Storage temperatures, shelf life, shipment and supportive temperature excursion information

May 19, 2023

Introduction

Information in this document provides additional details on shipment, storage temperatures, shelf-life, and supportive temperature excursion information to support distributors and end-users with necessary information and instructions to use the product in a safe and effective manner.

For information regarding the use of Imvamune, please refer to the product monograph available through Health Canada's Drug Product Database.

Storage and handling

An overview of all approved Imvamune (Modified Vaccinia Ankara-Bavarian Nordic) vaccine storage temperatures and shelf life in Canada for storage under frozen conditions is provided in Table 1. The assigned expiry date is presented in the MM/YYYY format. The vaccine should be used by the end of the calendar month printed on the carton, depending on the storage temperature used.

Table 1: Overview of approved Imvamune shelf life in Canada for storage at -20°C, -50°C and -80°C from date of manufacture.
Storage temperature	Market	Approved shelf life from date of manufacture
-20°C ± 5°C	CAN	3 years^{Footnote *}
-50°C ± 10°C	CAN	5 years^{Footnote **}
-80°C ± 10°C	CAN	9 years
Table 1 Footnote * Shelf life extension from 2 to 3 years approved by Health Canada in March 2023; see information below. Return to footnote * referrer
Table 1 Footnote Shelf life extension from 2 to 5 years approved by Health Canada in March 2023; see information below. Return to footnote referrer

Please note that data to support shelf life extensions at storage temperatures of -20°C ± 5°C, -and 50°C ± 10°C have been approved by Health Canada. These shelf life extensions apply from the date of manufacture when the product is stored long-term at the approved storage temperature. An updated Canadian Product Monograph (CPM) reflecting the shelf-life extensions is available on Health Canada's Drug Product Database.

If removing from freezer storage for use, thaw at refrigeration or room temperature. Thawing at room temperature will take approximately 10 minutes if taken from -20°C, -50°C, or -80°C. Do not refreeze the drug product once thawed. The product should be kept in the original packaging and protected from light.

As per Table 2, unopened vials of Imvamune are approved for storage at 2°C to 8°C for up to 2 months (8 weeks) from the time of thawing. A shelf life extension from 2 to 8 weeks at this storage temperature was approved by Health Canada. The shelf life extension applies to product stored at an approved storage temperature (-20°C, -50°C, or -80°C) and within the approved shelf-life prior to thawing.

Table 2: Overview of approved Imvamune shelf life in Canada for storage at 2°C to 8°C
Storage temperature	Market	Approved shelf life
After prior storage at -20°C, -50°C, or -80°C (if within approved respective shelf-life)
2°C to 8°C	CAN	2 months (8 weeks)^{Footnote *}
Table 2 Footnote * Shelf-life extension from 2 to 8 weeks approved by Health Canada in March 2023. Return to footnote * referrer

There are no data available on the storage of the product in a syringe prior to use; as such, it's recommended for the product to remain in the original glass vial until immediately before use. It's also not recommended to remove individual vials from a package in a frozen state to store in the refrigerator unless you can do so in a manner where the rest of the package remains frozen.

Shelf-life considerations

To support shipment and storage of Imvamune at higher temperatures after long-term storage at -80°C, additional data was reviewed by Health Canada. Analysis of stability data supports that the vaccine remains stable for up to 3 months (91 days) at -20°C following long-term storage at -80°C (within the approved -80°C shelf-life).

Therefore, as per Table 3, to maintain the approved shelf-life of 9 years at -80°C, the cumulative time of shipment or storage at -20°C must not exceed 3 months (91 days) before return to long-term storage at -80°C . This assessment is applicable for batches already delivered to Canada and subsequent batches.

Table 3: Overview of allowable shipment and storage time at -20°C following long-term storage at -80°C to maintain a 9-year shelf-life
Storage Temperature	Market	Cumulative Storage Time
After prior storage at -80°C (and within the approved shelf-life)
-20°C ± 5°C	CAN	3 months (91 days)

Shipment

To support operational flexibility, Imvamune may be shipped either frozen at -20°C ± 5°C or refrigerated at 2°C to 8°C, depending on freezer capacity at the receiving site(s).

If the vaccine is shipped frozen at -20°C ± 5°C and requires storage before use, maintain:

Frozen (-80°C ± 10°C), if freezer capacity is available; or
Frozen (-20°C ± 5°C), if freezer capacity is available; or
Refrigerated (2°C to 8°C). Do not refreeze.

If the vaccine is shipped at 2°C to 8°C and requires storage before use, maintain:

Refrigerated at 2°C to 8°C. Do not refreeze.

Available stability data suggests that up to 5 cycles of shipment at -20°C ± 5°C and storage at -80°C should not impact the product quality. While Imvamune has been shown to be stable at -80°C ± 10°C; there is currently no shipping data available to support the shipment of vaccine at this lower temperature. Jurisdictions that elect to ship Imvamune at ultra-low temperatures do so at their own risk and should take extra precautions to maintain the cold-chain and prevent direct contact between vials and dry ice.

Figure 1 depicts the worst-case scenario of 5 cycles of shipment for Imvamune. Shipment from the manufacturer to PHAC in Canada is considered the first shipment.

Figure 1. Text version below. — **Figure 1: Overview of the 5 available cycles of shipment for Imvamune**

Figure 1: Summary of the 5 available cycles of shipment for Imvamune
Description	Temperature
Storage	-80 ± 10°C
Shipment 1	-20 ± 5°C
Storage	-80 ± 10°C
Shipment 2	-20 ± 5°C
Storage	-80 ± 10°C
Shipment 3	-20 ± 5°C
Storage	-80 ± 10°C
Shipment 4	-20 ± 5°C
Storage	-80 ± 10°C
Shipment 5	-20 ± 5°C
Storage	-20 ± 5°C
Refrigerator Storage for 8 Weeks	2°C to 8°C

In general, it's recommended to avoid repeated transitions of the drug product between different temperatures. Therefore, if several shipments are planned within a short interval, intermediate storage at -20°C would be preferred over additional intermediate storage at -80°C. There is no need for a reset time/cool-down period between each shipment and storage.

Temperature excursions

In the case of a temperature excursion, there's supportive data to show that up to 2 excursions of 30-minutes at either 2°C to 8°C or +20°C do not have an impact on long-term stability when the product is subsequently returned to either short- or long-term storage at -20°C. This data was included and reviewed in submission from the manufacturer but not included in the label claim. The stability data was created based on the product stored at -20°C. While there is no data available for excursions during storage at -80°C or -50°C, in principle, the stability data for excursions during storage at -20°C can be taken into consideration in these situations.

Additionally, there are data to support the stability of Imvamune for temperature excursions up to 20°C during storage at +2°C to 8°C. The cumulative allowable time is 60 minutes.

The following table can be used as a reference for how to handle temperature excursions:

Table 4: Guidance for handling of temperature excursions
Storage temperature	Shipment temperature	Allowable time (accumulative time)	Action
-20°C ± 5°C	Below -15°C	Until the expiry of the product	None

Temperature range	Reason for excursion	Allowable time	Action
-15°C to -3°C	Shipping excursion, inspections, rework	≤ 60 min	None
-15°C to 0°C	Shipping excursion, inspections, rework	≤ 60 min (or 2* 30 min)	Data available to support no impact on the quality of the product; data are included in the filing but not as a label claim
0°C to +20°C	Shipping excursion. Inspections etc.	≤ 60 min (or 2* 30 min)	Data available to support no impact on the quality of the product; data are included in the filing but not as a label claim
>+20°C	Storage excursion	None	No data are available; the product should be rejected

Contact details

If you have further questions related to the storage, handling, or shelf-life of Imvamune, please contact the Bavarian Nordic Medical Information Team.

Phone number: 1-844-422-8274

Email: medical.information_us@bavarian-nordic.com

Hours of operation for the telephone line are from 8 am to 4:30 pm CST.

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Date modified:: 2023-05-23

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