Monday, Moderna, Inc.'s (NASDAQ:MRNA) manufacturing facility in Laval, Quebec, received a Drug Establishment License (DEL) from Health Canada.
This certification affirms the facility's compliance with safety and quality standards, authorizing it to produce drug substances.
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 License 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.
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"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, including key U.S. facilities and facilities under construction in Australia and the U.K.
Recently, the FDA granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) from Moderna and Pfizer Inc (NYSE:PFE)/ BioNTech SE (NASDAQ:BNTX).
Price Action: MRNA stock is up 6.70% at $77.77 at the last check Monday.
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