IMVAMUNE Vaccine: Updated storage conditions and shelf life
In plain language
This notice provides updated storage conditions and shelf life information for the IMVAMUNE Smallpox and Monkeypox Vaccine in Canada. This update reflects new data on storing vaccine vials at different temperatures. Healthcare professionals should follow the updated guidelines for storage and expiry.
What to do
- Healthcare professionals should note the updated storage conditions.
- Vaccine vials can be stored at -20°C for up to 3 months after long-term storage at -80°C.
- The initial expiry date for -80°C storage becomes invalid in this case.
- No change to shelf life if vials remain at -80°C.
- Thawed vials can still be held at 2°C – 8°C for up to 2 weeks.
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Affected products
IMVAMUNE Smallpox and Monkeypox Vaccine Modified Vaccinia Ankara-Bavarian Nordic® (live-attenuated, non-replicating), Suspension for Injection
Lot: P00021, P00034, P00035, P00036, P00037
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: P00021, P00034, P00035, P00036, P00037
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This notice provides updated storage conditions and shelf life information for the IMVAMUNE Smallpox and Monkeypox Vaccine in Canada. This update reflects new data on storing vaccine vials at different temperatures. Healthcare professionals should follow the updated guidelines for storage and expiry.
What should consumers do?
Healthcare professionals should note the updated storage conditions. Vaccine vials can be stored at -20°C for up to 3 months after long-term storage at -80°C. The initial expiry date for -80°C storage becomes invalid in this case. No change to shelf life if vials remain at -80°C. Thawed vials can still be held at 2°C – 8°C for up to 2 weeks.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on July 29, 2022.
Is the IMVAMUNE brand affected by this recall?
Yes, IMVAMUNE products are affected by this recall. This notice provides updated storage conditions and shelf life information for the IMVAMUNE Smallpox and Monkeypox Vaccine in Canada. This update reflects new data on storing vaccine vials at different temperatures. Healthcare professionals should follow the updated guidelines for storage and expiry.