Moderna's Canadian manufacturing facility has been granted a Drug Establishment License (DEL) from Health Canada.
The site, positioned in Laval, Quebec has now been affirmed as compliant with safety and quality standard, which allows it to produce drug substances for the domestic market.
The regulatory approval from Health Canada means the site is now fully operational, allowing Moderna to provide an onshore supply of mRNA vaccines to the population of Canada.
Now the facility has bagged the DEL, it will need to proceed to the final qualification process, which will likely allow the company to begin the manufacture of mRNA vaccines at the beginning of 2025.
Moderna will produce vaccines for a range of respiratory diseases, including COVID-19 and — contingent on approval from Health Canada — respiratory synctial virus (RSV) and seasonal influenza.
The CEO of Moderna, Stéphane Bancel, commented: "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 US to reach this milestone."
Laval's Manufacturing Site Head, Roger Ngassam, added: "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,"
"This platform will be the foundation for enabling the manufacturing of multiple mRNA vaccines right here in Canada."
The approval builds on Moderna's North American manufacturing footprint, with sites already operating in the US.
The company also has facilities in construction in the UK and Australia.
