Moderna’s Canadian Manufacturing Facility Receives Drug Establishment License From Health Canada
Moderna's manufacturing facility in Laval, Quebec, has received a Drug Establishment License (DEL) from Health Canada, marking a significant step towards producing mRNA vaccines in Canada by 2025. This certification authorizes the facility to produce drug substances and enables it to become fully operational. The site is expected to manufacture a portfolio of mRNA vaccines against respiratory viruses, including COVID-19, RSV, and seasonal influenza, starting in 2025, subject to Health Canada approval.
This achievement is part of Moderna's strategic partnership with the Canadian government to support national pandemic readiness and provide onshore manufacturing capabilities. The Laval facility is Moderna's first manufacturing site outside the U.S. to reach this milestone, complementing its existing and planned facilities in the United States, Australia, and the UK.
Lo stabilimento di produzione di Moderna a Laval, Quebec, ha ricevuto una Licenza di Stabilimento Farmaceutico (DEL) da Salute Canada, segnando un passo significativo verso la produzione di vaccini mRNA in Canada entro il 2025. Questa certificazione autorizza lo stabilimento a produrre sostanze farmaceutiche e consente di diventare completamente operativo. Si prevede che il sito produca un portafoglio di vaccini mRNA contro i virus respiratori, inclusi COVID-19, RSV e influenza stagionale, a partire dal 2025, previa approvazione di Salute Canada.
Questo traguardo fa parte della partnership strategica di Moderna con il governo canadese per supportare la preparazione nazionale alla pandemia e fornire capacità di produzione nazionale. Lo stabilimento di Laval è il primo sito di produzione di Moderna al di fuori degli Stati Uniti a raggiungere questo obiettivo, complementando le sue strutture esistenti e pianificate negli Stati Uniti, in Australia e nel Regno Unito.
La instalación de fabricación de Moderna en Laval, Quebec, ha recibido una Licencia de Establecimiento de Medicamentos (DEL) de Salud Canadá, marcando un paso significativo hacia la producción de vacunas de ARNm en Canadá para 2025. Esta certificación autoriza a la instalación a producir sustancias farmacéuticas y la habilita para operar plenamente. Se espera que el sitio fabrique un portafolio de vacunas de ARNm contra virus respiratorios, incluyendo COVID-19, RSV y gripe estacional, comenzando en 2025, sujeto a la aprobación de Salud Canadá.
Este logro es parte de la asociación estratégica de Moderna con el gobierno canadiense para apoyar la preparación nacional ante pandemias y proporcionar capacidades de fabricación en el país. La instalación de Laval es el primer sitio de fabricación de Moderna fuera de EE. UU. en alcanzar este hito, complementando sus instalaciones existentes y planificadas en Estados Unidos, Australia y el Reino Unido.
모더나의 퀘벡 라발에 있는 제조 시설이 캐나다 보건부로부터 의약품 제조 시설 라이센스 (DEL)를 획득하여, 2025년까지 캐나다에서 mRNA 백신을 생산하는 데 중요한 첫걸음을 내디뎠습니다. 이 인증은 시설이 의약품을 생산할 수 있도록 허가하며 전적으로 운영될 수 있게 합니다. 해당 사이트는 COVID-19, RSV, 계절성 인플루엔자를 포함한 호흡기 바이러스에 대한 mRNA 백신 포트폴리오를 2025년부터 생산할 것으로 기대되며, 이는 캐나다 보건부의 승인을 받아야 합니다.
이 성과는 모더나가 캐나다 정부와 함께 국가 팬데믹 대비를 지원하고 본토 제조 능력을 제공하기 위한 전략적 파트너십의 일환입니다. 라발 시설은 모더나가 미국 외에서 이 이정표를 달성한 첫 번째 제조 시설로, 미국, 호주 및 영국에 있는 기존 및 계획 중인 시설을 보완합니다.
L'installation de fabrication de Moderna à Laval, au Québec, a reçu une Licence d'Établissement de Médicaments (DEL) de Santé Canada, marquant une étape significative vers la production de vaccins à ARNm au Canada d'ici 2025. Cette certification autorise l'installation à produire des substances médicamenteuses et lui permet de devenir pleinement opérationnelle. On s'attend à ce que le site fabrique un portefeuille de vaccins à ARNm contre les virus respiratoires, y compris COVID-19, VRS et grippe saisonnière, à partir de 2025, sous réserve de l'approbation de Santé Canada.
Cette réalisation fait partie du partenariat stratégique de Moderna avec le gouvernement canadien pour soutenir la préparation nationale aux pandémies et fournir des capacités de fabrication sur place. L'installation de Laval est le premier site de fabrication de Moderna en dehors des États-Unis à atteindre ce jalon, complétant ses installations existantes et planifiées aux États-Unis, en Australie et au Royaume-Uni.
Die Produktionsstätte von Moderna in Laval, Quebec, hat eine Arzneimittelherstellungs Lizenz (DEL) von Health Canada erhalten, was einen bedeutenden Schritt in Richtung der Herstellung von mRNA-Impfstoffen in Kanada bis 2025 darstellt. Diese Zertifizierung autorisiert die Anlage zur Herstellung von Arzneimittelstoffen und ermöglicht es ihr, voll funktionsfähig zu werden. Voraussichtlich wird der Standort ein Portfolio von mRNA-Impfstoffen gegen Atemwegsviren herstellen, einschließlich COVID-19, RSV und saisonale Influenza, beginnend im Jahr 2025, vorbehaltlich der Genehmigung durch Health Canada.
Dieser Erfolg ist Teil von Modernas strategischer Partnerschaft mit der kanadischen Regierung zur Unterstützung der nationalen Pandemie-Bereitschaft und zur Bereitstellung von Inlandsproduktionskapazitäten. Die Laval-Anlage ist Modernas erste Produktionsstätte außerhalb der USA, die diesen Meilenstein erreicht, und ergänzt die bestehenden und geplanten Einrichtungen in den Vereinigten Staaten, Australien und dem Vereinigten Königreich.
- Received Drug Establishment License from Health Canada for Laval facility
- Authorized to produce drug substances in Canada
- Positioned to manufacture mRNA vaccines domestically by 2025
- First manufacturing site outside the U.S. to reach this milestone
- Supports national pandemic readiness in Canada
- Expands global manufacturing footprint
- None.
Insights
The granting of a Drug Establishment License (DEL) by Health Canada to Moderna's Laval facility is a significant regulatory milestone. This certification validates the facility's compliance with stringent safety and quality standards, a important step for pharmaceutical manufacturing. The DEL allows Moderna to produce drug substances in Canada, marking a pivotal moment in the company's expansion beyond U.S. borders.
This development aligns with global trends towards localized vaccine production, enhancing national security and pandemic preparedness. The ability to manufacture mRNA vaccines domestically by 2025 could potentially streamline supply chains and reduce reliance on imports. However, the true impact will depend on the facility's production capacity and the demand for mRNA vaccines in the coming years.
Moderna's expansion into Canadian manufacturing represents a strategic investment in its global production network. While the immediate financial impact may be , this move positions Moderna for long-term growth in the Canadian market and beyond. The facility's ability to produce multiple mRNA vaccines could diversify revenue streams and mitigate risks associated with market fluctuations or changes in demand for specific products.
Investors should consider the potential for increased market share in Canada and improved operational efficiency through localized production. However, it's important to monitor the capital expenditure required for full operationalization and the timeline for reaching production capacity. The facility's success will be measured by its ability to contribute meaningfully to Moderna's bottom line in the medium to long term.
The establishment of Moderna's mRNA vaccine production facility in Canada marks a significant advancement in public health preparedness. By 2025, Canada will have domestic manufacturing capabilities for important vaccines against COVID-19, RSV and seasonal influenza. This local production capacity could enhance vaccine accessibility and reduce response times during future health crises.
The facility's versatility in producing multiple mRNA vaccines demonstrates the adaptability of the technology. This flexibility could prove invaluable in rapidly addressing emerging health threats. However, it's important to note that the success of this initiative will depend on ongoing collaboration between Moderna, Health Canada and other stakeholders to ensure that production aligns with public health needs and regulatory standards.
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.
View the original press release on accesswire.com
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