Moderna Inc. (Nasdaq:MRNA) announced on Monday that its Canadian manufacturing facility, which is located in Laval, has been granted a Drug Establishment License (DEL) by Health Canada.
The certification, according to a statement issued by the company, 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,” said Moderna.
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 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 at Moderna Canada.
“This platform will be the foundation for enabling the manufacturing of multiple mRNA vaccines right here in Canada,” he added.
“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.”
The DEL status adds to Moderna’s existing global manufacturing footprint, which includes key facilities in the United States, as well as facilities under construction in Australia and the United Kingdon.
According to the company, the Laval facility will be playing a crucial role in furthering Moderna’s positive impact on global health, while contributing to the local economy, and ensuring Canadian access to safe, high-quality mRNA medicines.
Cambridge, Massachusetts-based Moderna focuses on RNA therapeutics – mainly mRNA vaccines.
The company, which underwent a massive surge in growth during the Covid pandemic, has only one commercial product so far, which is the Moderna COVID-19 vaccine.
However, Moderna has 45 treatment and vaccine candidates, of which 38 have reached the advanced stage of clinical trials.
They include potential vaccines for influenza, HIV, Epstein-Barr human herpes, and several vaccines against cancer.
