Moderna Receives Health Canada Approval for Canadian Production of COVID-19 Vaccine
TORONTO, ON – Moderna announced it has received Health Canada approval, via a Supplemental New Drug Submission (SNDS), to manufacture its COVID-19 mRNA vaccine in Canada. The authorization allows end-to-end domestic production: drug substance will be produced at Moderna’s new facility in Laval, Que., while fill-finish work will be handled by Novocol Pharma in Cambridge, Ont. Canadian-made doses are on track to begin reaching Canadians later this year.
Moderna has submitted an updated COVID-19 vaccine, targeting the LP.8.1 virus strain, to Health Canada for review. The domestically produced version of this vaccine is expected to be ready in time to support the 2025 fall vaccination campaign, subject to Health Canada approval timelines.
This approval lays the groundwork for qualifying Moderna’s domestic manufacturing network for additional mRNA products—an important step under our long-term agreement with the Government of Canada to strengthen pandemic preparedness and build long-term health resilience through onshore vaccine production.
With this approval, Canada becomes the first country outside the United States where a Moderna site is ready for commercial COVID-19 vaccine production. Newly built sites in Australia and the United Kingdom are operational and advancing through final regulatory approvals, with product authorizations expected to follow.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.
Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit https://www.modernatx.com/en-CA.
Moderna Contacts:
Canada Media:
Sacha Kennedy
Director, Communications & Media Relations, Canada
sacha.kennedy@modernatx.com
International Media:
Chris Ridley
Global Head of Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com
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