Moderna has announced that its Laval, Quebec manufacturing facility has received a drug establishment licence (DEL) from Health Canada, to aid in the domestic production of mRNA vaccines.

The certification validates the facility's adherence to stringent safety and quality standards, allowing it to produce drug substances.

With the receipt of DEL, the Canadian manufacturing plant can now operate at full capacity to provide a consistent and local supply of mRNA vaccines within the country.

Moderna CEO Stéphane Bancel stated: “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.

“We look forward to continuing our work with the government of Canada to support the national supply of vital respiratory vaccines.”

The facility is set to complete its final qualification process, with plans to manufacture a range of mRNA vaccines for respiratory viruses by 2025.

This includes vaccines for Covid-19 and, pending Health Canada's approval, for respiratory syncytial virus (RSV) and seasonal influenza.

Moderna is expanding its global manufacturing network with the Canadian site joining established facilities in the US and others under construction in Australia and the UK.

Moderna Canada Laval manufacturing site head Roger Ngassam stated: “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.”

In February 2024, Moderna completed the construction of the Laval facility.

The construction of the facility is a milestone in Moderna's partnership with the Canadian government, aimed at strengthening the country's pandemic preparedness.

The project, partly funded by the government of Quebec through Investissement Québec, is also set to create high-skilled jobs and support the local workforce.

In July 2024, Moderna received a grant of $176m through the Rapid Response Partnership Vehicle (RRPV) Consortium to expedite the development of mRNA-based pandemic influenza vaccines.