IMVAMUNE Vaccine: Updated Storage Conditions and Shelf Life

Issue

On July 27, 2022, Bavarian Nordic submitted data to Health Canada characterizing shelf life for alternative storage conditions for IMVAMUNE. The IMVAMUNE Vaccine Product Monograph indicates: “Store frozen at -20°C ± 5°C or -50°C ± 10°C or -80°C ± 10°C. Expiry date depends on storage temperature.” However, the Product Monograph does not provide additional information on shelf life if the vaccine is moved between different storage temperatures. Audience Healthcare professionals including infectious disease physicians, pharmacists, family physicians, public health officials, nurses and nurse practitioners. Healthcare professionals at the identified Points of Use (POUs). The Public Health Agency of Canada is distributing IMVAMUNE Vaccine (DIN 02416638) doses to provinces, territories, and some federal departments, which are further distributed to vaccination locations where administration of the vaccine will occur, as outlined by the provincial governments and public health authorities. Key Messages On November 5, 2020, IMVAMUNE (DIN 02416638) was authorized by Health Canada for active immunization against smallpox, monkeypox and related orthopoxvirus infections and disease in adults 18 years of age and older determined to be at high risk for exposure. Healthcare professionals are advised that IMVAMUNE Vaccine storage conditions and shelf life have been updated to reflect that IMVAMUNE Vaccine vials can be stored at -20°C for up to 3 months following long term storage at -80°C. The initially assigned expiry date for storage at -80°C will become invalid. This new information is based on stability data that Bavarian Nordic has provided to Health Canada and is applicable to lots: P00021, P00034, P00035, P00036, P00037. This change is reflected within the updated lot release letters approved by Health Canada on July 27, 2022, which are available upon request to Health Canada or to Bavarian Nordic. As additional lots become available, Health Canada will assess any new information and will provide updates as required. At this time, no changes are being made to the Product Monograph. There is no change of shelf life if the vaccine vials are kept at -80°C prior to use. The expiry information provided with the product remains accurate. Thawed vials can be held at 2°C – 8°C for up to 2 weeks. This information has not changed from the currently approved Product Monograph and remains applicable. Background Information IMVAMUNE is indicated for active immunization against smallpox, monkeypox and related orthopoxvirus infection and disease in adults 18 years of age and older determined to be at high risk for exposure. The vaccine may be used for both primary vaccination and revaccination. IMVAMUNE does not contain smallpox or monkeypox virus and cannot spread or cause smallpox or monkeypox. IMVAMUNE is a Modified Vaccinia Ankara (MVA) vaccine initially authorized for use in Canada on November 21, 2013, as an Extraordinary Use New Drug Submission (EUNDS) for use by the Canadian Government in an emergency situation for active immunization against smallpox infection and disease in persons 18 years of age and older who have a contraindication to the first or second generation smallpox vaccines. It was subsequently authorized under a supplement to the EUNDS on November 5, 2020 for active immunization against smallpox, monkeypox and related orthopoxvirus infections and disease in adults 18 years of age and older determined to be at high risk for exposure. Vaccination against smallpox was demonstrated through several observational studies to be about 85% effective in preventing monkeypox. The IMVAMUNE Vaccine Product Monograph indicates: “Store frozen at -20°C ± 5°C or -50°C ± 10°C or -80°C ± 10°C. Expiry date depends on storage temperature. Can be stored at 2°C – 8°C for up to 2 weeks.” “Do not use after the expiry date shown on the label, unless batch certification documentation allows for use based on an updated expiry date.” However, the Product Monograph does not provide additional information on shelf life if moved between different storage temperatures. Based on updated information from Bavarian Nordic, IMVAMUNE vials (of specific lots: P00021, P00034, P00035, P00036, P00037) may be stored at -20°C for up to 3 months following long term storage at -80°C. No changes to the Product Monograph are being made at this time. Health Canada and Bavarian Nordic are reviewing information on a lot-by-lot basis. Health Canada will share any new information as required. Information for healthcare professionals The IMVAMUNE Vaccine storage conditions and shelf life have been updated to reflect: After being removed from long term storage at -80°C, vaccine vials can be stored at -20°C for up to 3 months. The initially assigned expiry date for storage at -80°C will become invalid. No change of shelf life if the vaccine vials are kept at -80°C prior to use. The expiry information provided with the product remains accurate. Thawed vials can be held at 2°C – 8°C for up to 2 weeks, which has not changed from the currently approved Product Monograph. This new information is applicable to lots: P00021, P00034, P00035, P00036, P00037. As additional lots become available, Health Canada will assess any new information and will provide updates as required. Bavarian Nordic has provided stability data to support the storage of the IMVAMUNE Vaccine vials at -20°C for up to 3 months following long term storage at -80°C. This change is reflected within the updated lot release letters approved by Health Canada on July 27, 2022, which are available upon request to Health Canada or to Bavarian Nordic. At this time, no changes are being made to the Product Monograph. Action taken by Health Canada Health Canada continues to work with Bavarian Nordic to review any new information on the IMVAMUNE vaccine. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system, as well as through social media channels, including LinkedIn and Twitter. Report health or safety concerns Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any serious or unexpected side effects in patients receiving IMVAMUNE Vaccine should be reported to your local Health Unit. If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory and send it to your local Health Unit. For other health product inquiries related to this communication, contact Health Canada at: Biologic and Radiopharmaceutical Drugs Directorate E-mail: hc.brdd.dgo.enquiries.sc@hc-sc.gc.ca.ca

What you should do

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