Moderna’s Canadian Manufacturing Facility Receives Drug Establishment License From Health Canada

Moderna, Inc. announced that its manufacturing facility in Laval, Quebec, has been granted a Drug Establishment License (DEL) from Health Canada. This certification confirms the facility's adherence to stringent safety and quality standards, allowing it to produce drug substances. This milestone enables Moderna's Canadian site to become fully operational, moving the company closer to providing a reliable supply of mRNA vaccines within Canada.

With the DEL approval, the Laval facility will proceed with final qualifications, targeting domestic production of mRNA vaccines against respiratory viruses by 2025. These include vaccines for COVID-19 and, pending Health Canada approval, for respiratory syncytial virus (RSV) and seasonal influenza.

Stéphane Bancel, CEO of Moderna, emphasized the significance of this achievement and its role in bringing certified end-to-end mRNA manufacturing capabilities to Canada. Roger Ngassam, Head of the Laval Manufacturing Site, highlighted the long-term strategic partnership with the Government of Canada aimed at fortifying national pandemic readiness.

This milestone also builds on Moderna’s current manufacturing footprint in the U.S., with additional facilities underway in Australia and the UK. The Laval facility is expected to bolster the company's positive impact on global health, contribute to the local economy, and ensure that Canadians have access to safe, high-quality mRNA medicines.