Moderna’s Canadian Manufacturing Facility Receives Drug Establishment License From Health Canada

Milestone marks a significant step toward producing mRNA vaccines in Canada by 2025

CAMBRIDGE, MA / ACCESSWIRE / September 9, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that its manufacturing facility in Laval, Quebec, has been granted a Drug Establishment License (DEL) from Health Canada. This certification 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.

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 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, which includes key facilities in the United States, as well as facilities under construction in Australia and the UK. This Canadian facility will play a crucial role in furthering the Company's positive impact on global health, contributing to the local economy, and ensuring that Canadians have access to safe, high-quality mRNA medicines.

For more details on Moderna's Laval facility, please refer to our previous update here.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's ability to produce mRNA vaccines in Canada by 2025; Moderna's ability to gain regulatory approval from Health Canada for its respiratory vaccines; final qualification processes at the Laval site; and facilities under construction in Australia and the UK. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:

International media
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Moderna in Canada
Sacha Kennedy
Director, Communications and Media
sacha.kennedy@modernatx.com

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.