Shelf life extension for the spikevax (elasomeran) covid-19 vaccine with printed expiry dates on vial and carton labels

On December 23, 2021, Health Canada authorized a shelf-life extension, from 7 months to 9 months, for SPIKEVAX / COVID-19 Vaccine Moderna 5 mL vials. This 2-month extension may be retroactively applied to vials that are currently on the market with printed expiry dates between February 2022 and August 2022, as long as the approved storage conditions have been maintained. 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. Key messages Health Canada has authorized a shelf-life extension, from 7 months to 9 months, for SPIKEVAX / COVID-19 Vaccine Moderna 5 mL vials. This 2-month extension may be retroactively applied to vials that are currently on the market with printed expiry dates between February 2022 and August 2022 (see Products affected section), as long as the approved storage conditions have been maintained. Healthcare professionals are advised that: The expiration date of vaccines must be verified prior to vaccination. The Canadian-specific labelling information, including the SPIKEVAX Product Monograph and training materials, can be accessed at www.modernacovid19global.com/ca, or by scanning the QR code on the English-only vial and carton labels. This information is also available on the federal government’s covid-vaccine.canada.ca website. The Canadian SPIKEVAX Product Monograph in French and English is also available on Health Canada’s Drug Product Database. Background SPIKEVAX is indicated for active immunization against coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. Health Canada has authorized a 2-month shelf-life extension for SPIKEVAX / COVID-19 Vaccine Moderna, which is supported by scientific evidence. This 2-month shelf-life extension may be retroactively applied to vials currently on the market with a printed expiry date between February 2022 and August 2022 (see Products affected section). The storage conditions of -25ºC to -15ºC (-13ºF to 5ºF) remain unchanged. Within the 9-month shelf-life, unopened vials may be stored refrigerated at 2°C to 8°C (36ºF to 46ºF), protected from light, for a maximum of 30 days. Within this period, up to 12 hours may be used for transportation. Once thawed, the vaccine should not be re-frozen. The last vials to be subject to this retroactive shelf-life extension will be those with a printed expiry date of August 2022 (manufactured in January 2022). The new 9-month shelf-life will be printed on labels of SPIKEVAX beginning with vials manufactured as of February 2022. All vials with a printed expiry date of November 2022 onwards will reflect the authorized 9-month shelf-life. Information for healthcare professionals Healthcare professionals are advised that: On December 23, 2021, Health Canada authorized a shelf-life extension, from 7 months to 9 months, for the 5 mL vials of the SPIKEVAX / COVID-19 Vaccine Moderna. This 2-month extension may be retroactively applied to vials of SPIKEVAX currently on the market with printed expiry dates between February 2022 and August 2022 (see Products affected section), as long as the approved storage conditions have been maintained. Health Canada had previously authorized a 2-month shelf-life extension (from 7 months to 9 months) for certain lots of US-labelled vaccine supplies of SPIKEVAX (previously Moderna COVID-19 Vaccine). For additional information about the expiration date for those lots, please review the Health Product Risk Communication dated October 29, 2021. The expiration date of vaccines must be verified prior to vaccination. The Canadian SPIKEVAX Product Monograph, in French and English, is available on Health Canada’s Drug Product Database and should be used for complete product information. The Canadian-specific information, including the SPIKEVAX Product Monograph and training materials, can be accessed at www.modernacovid19global.com/ca, or by scanning the QR code on carton and vial labels. This information is also available on the federal government’s covid-vaccine.canada.ca website. Action taken by Health Canada Health Canada is permitting a retroactive application of the authorized 2-month shelf-life extension, from 7 to 9 months, for SPIKEVAX / COVID-19 Vaccine Moderna 5 mL vials with printed expiry dates between February 2022 and August 2022. Health Canada is communicating this important 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 SPIKEVAX should be reported to your local Health Unit or Moderna. Moderna Biopharma Canada Corporation c/o SE Corporate Services Ltd., Suite 1700, Park Place, 666 Burrard Street, Vancouver, BC V6C 2X8 Telephone: 1-866-663-3762 Fax: 1-866-599-1342 To correct your mailing address or fax number, contact Moderna Biopharma Canada Corporation at 1-866-MODERNA (1-866-663-3762). 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: brdd.dgo.enquiries@hc-sc.gc.ca Original signed by Leslie Madden, BSc, MBA, LLM Director, Head of Regulatory Affairs Canada ModernaTx, Inc.

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Brand: Spikevax Covid-19 Vaccine.