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.
On this page
- Introduction
- Storage and handling
- Shelf-life considerations
- Shipment
- Shipment cycle
- Temperature excursions
- Contact details
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.
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.
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.
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:
- Frozen (-80°C ± 10°C), if possible; or
- Frozen (-20°C ± 5°C), if possible; or
- Refrigerated (+2°C to +8°C). Do not refreeze.
- Time at +2°C to +8°C must not exceed 8 weeks, including storage and shipment.
If shipped at +2°C to +8°C and requires storage before use, store:
- Refrigerated at +2°C to +8°C. Do not refreeze.
- Time at +2°C to +8°C must not exceed 8 weeks, including storage and shipment.
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.

* The total time for shipment and storage at -20°C ± 5°C must be less than 3 months (91 days)
Figure 1 - Text description
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:
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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