Moderna, Inc. (MRNA) has achieved a major milestone in its efforts to establish a robust mRNA vaccine manufacturing presence in Canada. The company’s Laval, Quebec facility has secured a Drug Establishment License (DEL) from Health Canada, signifying that the site meets the highest safety and quality standards for drug production. This authorization enables the Canadian facility to become fully operational, bringing Moderna closer to its goal of ensuring a reliable and domestic supply of mRNA vaccines for Canadians.
With the DEL in place, Moderna’s Laval facility will move forward with the final qualification process. This sets the stage for domestic production of a portfolio of mRNA vaccines against respiratory viruses, including COVID-19, respiratory syncytial virus (RSV), and seasonal influenza, starting in 2025. The RSV vaccine is contingent on approval from Health Canada.
“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,” stated 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,” added 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 achievement builds upon Moderna’s existing global manufacturing infrastructure, which includes key facilities in the U.S. and ongoing construction projects in Australia and the U.K. Recently, the FDA granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) from both Moderna and Pfizer Inc. (PFE) / BioNTech SE (BNTX).
As of Monday, MRNA stock saw a surge of 6.70%, reaching $77.77 per share. The Canadian manufacturing facility represents a key strategic move for Moderna, solidifying its commitment to bolstering national vaccine supply chains and contributing to global health security.