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 affirms the facility’s compliance with rigorous safety and quality standards, authorizing it to produce drug substance. This key milestone enables Moderna’s Canadian manufacturing site to become fully operational, bringing the company closer to ensuring a reliable and onshore supply of mRNA vaccines within Canada.

With the DEL in place, the facility will proceed with the final qualification process, positioning it to domestically manufacture a portfolio of mRNA vaccines against respiratory viruses beginning in 2025, including COVID-19 and, contingent on approval by Health Canada, respiratory syncytial virus (RSV), and seasonal influenza.

“This is a significant achievement in our efforts to bring certified end-to-end mRNA manufacturing capabilities to Canada and is the first of our manufacturing sites outside the U.S. to reach this milestone,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to continuing our work with the Government of Canada to support the national supply of vital respiratory vaccines.”

“This is another landmark in Moderna’s long-term strategic partnership with the Government of Canada to provide onshore respiratory vaccine manufacturing capabilities and support national pandemic readiness,” said Roger Ngassam, Laval Manufacturing Site Head, Moderna Canada. “This platform will be the foundation for enabling the manufacturing of multiple mRNA vaccines right here in Canada.”

This milestone also builds on Moderna’s existing manufacturing footprint, which includes key facilities in the United States, as well as facilities under construction in Australia and the UK. This Canadian facility will play a crucial role in furthering the Company’s positive impact on global health, contributing to the local economy, and ensuring that Canadians have access to safe, high-quality mRNA medicines.