Moderna, Inc.: Moderna Receives Health Canada Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1

All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone

CAMBRIDGE, MA / ACCESS Newswire / August 22, 2025 / Moderna announced today that Health Canada has authorized its updated COVID-19 mRNA vaccine, Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant, for individuals aged six months and older. Moderna is on track to deliver the updated vaccine in time for the 2025-2026 vaccination season.

All Spikevax pre-filled syringe (PFS) doses for the Canadian market will now be manufactured domestically, marking the first time Canada's entire PFS format is produced at home. The drug substance will be produced at Moderna's new facility in Laval, Quebec, with fill-finish operations completed by Novocol Pharma in Cambridge, Ontario. These Canadian-made doses are expected to be available for this fall.

"This approval is a regulatory milestone and a testament to Canada's growing leadership in biomanufacturing and public health resilience," said Stéphane Bancel, Chief Executive Officer of Moderna. "Thanks to Health Canada's timely and thorough review, we are proud to supply Spikevax doses to communities across the country, including, for the first time this year, doses produced in Canada."

Moderna's updated COVID-19 vaccine targeting LP.8.1 has already been granted approval by regulators in Europe, Japan, Switzerland and other countries. Additional regulatory applications are under review around the world in preparation for the coming season.

Access and Distribution

Eligibility for the public vaccination program is set by each province and territory. Those who meet provincial criteria will receive the vaccine free of charge. For individuals not covered under the public programs, efforts are ongoing with private insurers and payers to streamline access and reimbursement within the private sector.

Canadians are encouraged to consult their provincial or territorial health authorities for the latest information on eligibility and availability.

Regulatory Basis

Health Canada's authorization is based on a comprehensive body of evidence submitted by Moderna, including clinical, non-clinical, and real-world data supporting the vaccine's safety and efficacy.[1]

[1] Moderna Canada. SPIKEVAX® Product Monograph. August 21, 2025.

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 the 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.

Spikevax® is a registered trademark of Moderna.

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: the availability of Moderna's updated COVID vaccine for the 2025-2026 vaccination season; Moderna's manufacturing; vaccine efficacy and safety; and Moderna's pending regulatory applications around the world. 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, 2024, 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:
Chris Ridley
Head of Global Media Relations
[phone]
[e-mail]

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
[phone]
[e-mail]

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/moderna-receives-health-canada-approval-for-updated-covid-19-vaccine-1064186