Moderna Announces First Made-in-Canada mRNA Vaccines Delivered to Canadian Provinces and Territories
Moderna (NASDAQ:MRNA) has achieved a significant milestone with the delivery of its first made-in-Canada mRNA vaccines to provinces and territories. The company's Spikevax® COVID-19 vaccine, targeting the SARS-CoV-2 LP.8.1 variant, is now fully manufactured in Canada with drug substance production in Laval, Quebec, and fill-and-finish operations in Cambridge, Ontario.
The vaccine, which received Health Canada approval on August 21, 2025, will be available through public vaccination programs, with timing and eligibility determined by individual provinces and territories. The company is also working with private insurers to ensure access for those not covered under public programs.
This development represents a major advancement in Canada's domestic vaccine production capacity and demonstrates the successful collaboration between government, industry, and scientific sectors.
Moderna (NASDAQ:MRNA) ha raggiunto una tappa significativa consegnando i suoi primi vaccini a mRNA prodotti in Canada alle province e ai territori. Il vaccino Spikevax® COVID-19, mirato alla variante SARS-CoV-2 LP.8.1, è ora interamente fabbricato in Canada, con la produzione della sostanza farmacologica a Laval (Quebec) e le operazioni di riempimento e rifinitura a Cambridge (Ontario).
Il vaccino, che ha ottenuto l'approvazione Health Canada l'21 agosto 2025, sarà disponibile attraverso i programmi di vaccinazione pubblici, con tempistiche ed eleggibilità determinate dalle singole province e territori. L'azienda sta inoltre collaborando con assicurazioni private per garantire l'accesso a chi non è coperto dai programmi pubblici.
Questo sviluppo rappresenta un avanzamento significativo nella capacità di produzione di vaccini domestici in Canada e dimostra la riuscita collaborazione tra governo, industria e settori scientifici.
Moderna (NASDAQ:MRNA) ha alcanzado un hito significativo al entregar sus primeras vacunas de ARNm fabricadas en Canadá a las provincias y territorios. La vacuna Spikevax® COVID-19, dirigida a la variante SARS-CoV-2 LP.8.1, ahora se fabrica completamente en Canadá, con la sustancia farmacéutica en Laval, Quebec, y las operaciones de llenado y acabado en Cambridge, Ontario.
La vacuna, que recibió la aprobación de Health Canada el 21 de agosto de 2025, estará disponible a través de los programas de vacunación públicos, con plazos y elegibilidad determinados por las respectivas provincias y territorios. La empresa también está colaborando con aseguradoras privadas para garantizar el acceso a quienes no estén cubiertos por los programas públicos.
Este desarrollo representa un avance importante en la capacidad de producción de vacunas domésticas en Canadá y demuestra la exitosa colaboración entre gobierno, industria y sectores científicos.
모더나(NASDAQ:MRNA)가 캐나다에서 생산된 첫 mRNA 백신을 주 및 준주에 전달하는 중요한 이정표를 달성했습니다. Spikevax® COVID-19 백신은 SARS-CoV-2 LP.8.1 변이를 표적하며, 캐나다에서 완전히 생산되며 물질 생산은 Laval(퀘벡), 충전 및 완성은 Cambridge(온타리오)에서 이루어집니다.
이 백신은 2025년 8월 21일 Health Canada의 승인을 받았으며, 공공 예방 접종 프로그램을 통해 이용 가능하되 시기와 자격 여부는 주 및 준주별로 결정됩니다. 또한 기업은 공공 프로그램에 포함되지 않는 이들을 위한 접근성을 보장하기 위해 민간 보험사와도 협력하고 있습니다.
이 발전은 캐나다의 국내 백신 생산 능력의 중요한 진전이며, 정부, 산업계 및 과학 분야 간의 성공적인 협력을 보여줍니다.
Moderna (NASDAQ:MRNA) a atteint une étape importante en livrant ses premiers vaccins à ARN messager fabriqués au Canada aux provinces et territoires. Le vaccin Spikevax® COVID-19, ciblant la variante SARS-CoV-2 LP.8.1, est désormais entièrement fabriqué au Canada, avec la production de la substance active à Laval (Québec) et les opérations de remplissage et de finition à Cambridge (Ontario).
Le vaccin, qui a reçu l'approbation de Santé Canada le 21 août 2025, sera disponible via les programmes publics de vaccination, avec des délais et éligibilité déterminés par chaque province et territoire. L’entreprise travaille également avec des assureurs privés pour garantir l’accès à ceux qui ne sont pas couverts par les programmes publics.
Ce développement représente une avancée majeure dans la capacité de production locale de vaccins au Canada et démontre la collaboration réussie entre le gouvernement, l’industrie et les secteurs scientifiques.
Moderna (NASDAQ:MRNA) hat einen wichtigen Meilenstein erreicht, indem sie ihre ersten in Kanada hergestellten mRNA-Impfstoffe an Provinzen und Territorien ausgeliefert hat. Der Spikevax® COVID-19-Impfstoff, der auf die SARS-CoV-2-Variante LP.8.1 abzielt, wird nun vollständig in Kanada hergestellt, mit der Wirkstoffproduktion in Laval, Québec, und Füll- und Endfertigung in Cambridge, Ontario.
Der Impfstoff, der am 21. August 2025 von Health Canada zugelassen wurde, wird über öffentliche Impfprogramme verfügbar sein, wobei Timing und Zugangsberechtigungen von den einzelnen Provinzen und Territorien festgelegt werden. Das Unternehmen arbeitet auch mit privaten Versicherern zusammen, um den Zugang für Nicht-Programmberechtigte sicherzustellen.
Diese Entwicklung stellt eine bedeutende Weiterentwicklung der inländischen Impfstoffproduktion Kanadas dar und demonstriert die erfolgreiche Zusammenarbeit zwischen Regierung, Industrie und wissenschaftlichen Sektoren.
موديرنا (NASDAQ:MRNA) حققت خطوة مهمة بتسليمها أول لقاحات mRNA مصنوعة في كندا إلى المقاطعات والأقاليم. لقاح Spikevax® COVID-19، المستهدف لسلالة SARS-CoV-2 LP.8.1، أصبح مصنّعاً بالكامل في كندا مع إنتاج المادة الفعالة في لافال، كيبك، وعمليات الملء والتشطيب في كامبردج، أونتاريو.
حصل اللقاح على إذن Health Canada في 21 أغسطس 2025 وسيكون متاحاً من خلال برامج التطعيم العامة، مع تحديد التوقيت والأهلية من قبل المقاطعات والإقاليم الفردية. كما تعمل الشركة مع شركات التأمين الخاصة لضمان الوصول لأولئك غير المشمولين في البرامج العامة.
هذا التطور يمثل تقدماً رئيسياً في قدرة إنتاج اللقاحات المحلي في كندا ويظهر التعاون الناجح بين الحكومة والصناعة والقطاعات العلمية.
Moderna（纳斯达克股票代码 MRN A） 已在加拿大取得重要里程碑，向各省区交付了首批在加拿大制造的 mRNA 疫苗。该公司的 Spikevax® COVID-19 疫苗，针对 SARS-CoV-2 LP.8.1 变异株，现在已在加拿大实现全线生产，药物物质在拉瓦尔（魁北克）生产，灌装与最终加工在剑桥（安大略）完成。
该疫苗已于 2025 年 8 月 21 日获得加拿大卫生部批准，将通过公共接种计划提供，时间表和资格由各省区自行决定。公司也在与私人保险机构合作，确保那些未纳入公共计划的人也能获得接种。
这一发展标志着加拿大本土疫苗生产能力的重大提升，展示了政府、行业和科学领域之间的成功合作。
- Establishment of first domestic mRNA vaccine manufacturing capability in Canada
- Strengthened national health security through local production capacity
- Multiple regulatory approvals received globally for the LP.8.1 variant vaccine
- Creation of new jobs and economic growth in Canadian life sciences sector
- Variable access and eligibility across different provinces and territories
- Ongoing negotiations required with private insurers for non-public program coverage
Insights
Moderna delivers first Canadian-made vaccines, strengthening domestic production capabilities and showcasing successful international manufacturing expansion.
Moderna has reached a significant operational milestone with the delivery of its first fully made-in-Canada mRNA vaccines to Canadian provinces and territories. The company is now manufacturing the drug substance for its Spikevax® COVID-19 vaccine targeting the SARS-CoV-2 LP.8.1 variant at its facility in Laval, Quebec, with fill-and-finish operations handled by Novocol Pharma in Cambridge, Ontario.
This development represents a strategic evolution in Moderna's global manufacturing footprint, demonstrating the company's ability to successfully transfer its complex mRNA technology to international facilities. The localized production capability directly addresses supply chain resilience - a critical factor that became evident during pandemic-related disruptions.
The timing is strategically aligned with the upcoming 2025-2026 respiratory virus season, positioning Moderna to meet Canadian demand with domestically-produced vaccines. This localization of manufacturing should reduce logistical complexities and potentially improve margins by eliminating certain transportation and import-related costs.
The Canadian facility's successful operation validates Moderna's manufacturing transfer process, which could be replicated in other markets. This creates a scalable blueprint for the company's global expansion strategy while fostering stronger governmental relationships. The political support evident in ministerial statements suggests a favorable regulatory environment for Moderna in Canada going forward.
Additionally, the implementation of a pre-filled syringe format represents a product delivery improvement that could enhance administration efficiency and potentially reduce wastage compared to multi-dose vials, though the full commercial impact of this format change remains to be quantified.
CAMBRIDGE, MA / ACCESS Newswire / September 19, 2025 / Moderna announced today that the first mRNA vaccines fully manufactured in Canada are being shipped to provinces and territories. This milestone advances Canada's domestic vaccine production capacity and strengthens national health security.
"The delivery of the first made-in-Canada mRNA vaccines to provinces and territories across the country marks a major milestone in our partnership with Canada," said Stéphane Bancel, Chief Executive Officer of Moderna. "This is not just about local manufacturing, it's about scientific leadership, national health security and ensuring Canadians have timely access to the latest mRNA medicines. We're proud to stand alongside Canada in advancing innovation, driving economic growth and investing in a resilient future for public health."
All drug substance of Moderna's authorized Spikevax® (COVID-19 mRNA vaccine) product targeting the SARS-CoV-2 LP.8.1 variant is manufactured at the facility in Laval, Quebec. Fill-and-finish of the new single-use pre-filled syringes is completed by Novocol Pharma in Cambridge, Ontario.
Moderna's updated COVID-19 vaccine targeting the LP.8.1 variant was approved by Health Canada on August 21, 2025 [1], and has also received authorization from regulators in the United States, Europe, Japan, Switzerland and several other countries. Additional regulatory submissions are under review globally in preparation for the 2025-2026 respiratory virus season.
Canadian Access and Eligibility
Timing and eligibility for the COVID-19 public vaccination program in Canada is set by each province and territory. Those who meet provincial criteria will receive COVID-19 vaccines 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.
Additional Quotes:
Stefan Raos, General Manager, Moderna Canada, said:
"As a Canadian, it's incredibly meaningful to see our first made-in-Canada COVID-19 vaccines in pre-filled syringes now reaching across the country to help protect Canadians starting this fall. This marks a critical shift, demonstrating that Canada's domestic manufacturing capability is real, operational and serving Canadians today. It reflects what's possible when science, industry and government work together with purpose."
The Honourable Mélanie Joly, Minister of Industry and Minister responsible for Canada Economic Development for Quebec Regions, said:
"Today's milestone of the production of the first made-in-Canada doses of Moderna's COVID-19 vaccine represents a major achievement for Canada's biomanufacturing and life sciences sector. Our government is building a resilient, forward-looking economy that positions Canada as a global leader in scientific research and innovation. Moderna's investments in Canada strengthen our national life sciences industry, create good-paying new jobs for Canadians and bolster our national security."
The Honourable Marjorie Michel, Minister of Health, said:
"Manufacturing the first-ever doses of a fully made-in-Canada COVID-19 vaccine demonstrates the power of collaboration between government, industry and science to help protect the health of Canadians. By producing vaccines here at home, we are supporting our economy while strengthening Canada's ability to respond quickly and effectively to future public health emergencies."
Images and b-roll can be found here.
[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 in Canadian provinces and territories of Moderna's updated COVID vaccine for the 2025-2026 vaccination season; Moderna's Canadian manufacturing; and Moderna's pending regulatory applications for approval of its COVID vaccine globally. 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:
Sacha Kennedy
Director, Communications and Media
+1 647-385-6846
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.
View the original press release on ACCESS Newswire
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