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

February 7, 2025

Note: This webpage was updated on February 7, 2025, to enhance clarity and remove information not relevant to the Canadian Market. Consequently, revisions were made to Tables 3 and 4, contact details, and the overall language throughout.

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Introduction

This document provides vaccine distributors and end-users with additional details on Imvamune shipment, storage temperatures, shelf-life, and temperature excursions to support the safe and effective use of this vaccine.

For detailed information on the use and administration of Imvamune, please refer to the current 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 under frozen conditions is provided in Table 1. The carton indicates the expiry dates in MM/YYYY format, based on the storage temperature. The vaccine is safe to use until the last day of the calendar month printed on the carton, depending on the storage temperature.

Table 1. Approved Imvamune shelf life in Canada for storage at -20°C, -50°C and -80°C from date of manufacture.
Storage temperature Approved shelf life from date of manufacture
-20°C ± 5°C 3 years
-50°C ± 10°C 5 years
-80°C ± 10°C 9 years

Please note that the approved shelf-life applies from the date of manufacture when the product is stored long-term at the approved storage temperature.

When removing Imvamune from the freezer for use, thaw it in the refrigerator (+2°C to +8°C) or at room temperature. Thawing at room temperature will take approximately 10 minutes. Please note do not refreeze the drug product once thawed. Keep it in its original packaging and protect it from light. For detailed instructions, please refer to the approved Canadian Product Monograph (CPM).

As outlined in Table 2, unopened vials of Imvamune that were previously stored at (-20°C or -80°C) can be stored at +2°C to +8°C for up to 2 months (8 weeks) after thawing, provided that the vaccine is within the approved shelf-life before thawing.

Table 2. Approved Imvamune shelf life in Canada for storage at +2°C to +8°C
Storage temperature Approved shelf life
After prior storage at -20°C or -80°C (if within approved respective shelf-life)
+2°C to +8°C 2 months (8 weeks)

Do not store Imvamune in a syringe prior to use, as there is no data available to support this practice. If removing single vials from a carton for thawing, make sure to return the carton to the freezer immediately to prevent temperature excursions and thawing of the remaining vials.

Shelf-life considerations

Health Canada has reviewed additional stability data to support shipment and storage of Imvamune at higher temperatures. As outlined in Table 3, the total time of Imvamune shipment and/or storage at -20°C (from date of manufacture) must not exceed 3 months (91 days) within the product's approved shelf-life when stored long-term at -80°C. This applies to batches already delivered to Canada and future batches.

Table 3. Total allowable time for interim shipment and storage at -20°C following long-term storage at -80°C
Previous Long-Term Storage Temperature Total number of cumulative days allowable at -20°C
-80°C ± 10°C (within 9-year shelf life) 3 months (91 days)

Shipment

To support operational flexibility, Imvamune can 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.

If shipped frozen at -20°C ± 5°C and requires storage before use, store:

If shipped at +2°C to +8°C and requires storage before use, store:

Although Imvamune can remain stable at -80°C ± 10°C, there is no data available to support shipping at this temperature. Jurisdictions that choose 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.

Shipment cycle

Stability data suggests that up to 5 cycles at -20°C ± 5°C and storage at -80°C ± 10°C should not impact product quality. However, it is recommended to avoid moving the product between different temperatures too often. If several shipments are planned within a short interval, intermediate storage at -20°C is preferred over storage at -80°C. No waiting or reset period is needed between shipments or storage.

Figure 1 provides an overview of the five available cycles of shipment for Imvamune. The first shipment is from the manufacturer to the Public Health Agency of Canada.

Figure 1: Overview of the five available cycles of shipment of Imvamune at -20°C ± 5°C.
Figure 1. Text version below.

* The total time for shipment and storage at -20°C ± 5°C must be less than 3 months (91 days)

Figure 1 - Text description
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

Temperature excursions

In the case of a temperature excursion, there are supportive data to show that up to 2 excursions of 30 minutes at temperatures ≤ 25°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. Although this information has been reviewed by Health Canada, it is not explicitly stated on product labelling or in official product information (i.e. the Canadian Product Monograph). The stability data was created based on the product stored at -20°C. While no data is available for excursions during storage at -80°C, in principle, the stability data for excursions during storage at -20°C can be considered in these situations.

Additionally, there are data to support the stability of Imvamune for temperature excursions up to +25°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 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 +25°C Shipping excursion, inspections, rework ≤ 60 min (or 2* 30 min periods) Based on available data, there is no impact to product quality. Document excursion as per established procedures.
> +25°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: 1-833-203-7933

Email: medical.information_NA@bavarian-nordic.com.

Hours of operation for the telephone line are from 8 am to 7 pm CST.

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