Moderna Receives Health Canada Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1
Moderna (NASDAQ:MRNA) has received Health Canada's approval for its updated COVID-19 vaccine Spikevax庐, targeting the SARS-CoV-2 LP.8.1 variant. The vaccine is authorized for individuals aged six months and older.
In a significant milestone for Canadian biomanufacturing, all 2025 pre-filled syringe doses will be manufactured domestically. The drug substance will be produced at Moderna's new Laval, Quebec facility, with fill-finish operations at Novocol Pharma in Cambridge, Ontario. The vaccine has already received approvals in Europe, Japan, and Switzerland, with additional regulatory reviews ongoing globally.
Moderna (NASDAQ:MRNA) ha ottenuto l'autorizzazione di Health Canada per la versione aggiornata del suo vaccino anti-COVID-19 Spikevax庐, mirata alla variante SARS-CoV-2 LP.8.1. Il vaccino 猫 autorizzato per le persone a partire dai sei mesi di et脿.
In un traguardo significativo per la produzione biomedica canadese, tutte le dosi in siringa pre-riempita previste per il 2025 saranno prodotte a livello nazionale. La sostanza medicinale verr脿 realizzata nel nuovo stabilimento di Moderna a Laval, Quebec, mentre le operazioni di riempimento e finitura saranno effettuate da Novocol Pharma a Cambridge, Ontario. Il vaccino ha gi脿 ottenuto approvazioni in Europa, Giappone e Svizzera, e sono in corso ulteriori valutazioni regolatorie a livello globale.
Moderna (NASDAQ:MRNA) ha recibido la aprobaci贸n de Health Canada para su vacuna COVID-19 actualizada Spikevax庐, dirigida a la variante SARS-CoV-2 LP.8.1. La vacuna est谩 autorizada para personas de seis meses en adelante.
En un hito importante para la bioproducci贸n canadiense, todas las dosis en jeringa prellenada previstas para 2025 se fabricar谩n en el pa铆s. La sustancia farmac茅utica se producir谩 en la nueva planta de Moderna en Laval, Quebec, y las operaciones de llenado y acabado se realizar谩n en Novocol Pharma en Cambridge, Ontario. La vacuna ya cuenta con aprobaciones en Europa, Jap贸n y Suiza, y contin煤a bajo revisi贸n regulatoria en otros lugares del mundo.
氇崝雮�(惭狈础厂顿础蚕:惭搁狈础)電� 鞐呺嵃鞚错姼霅� COVID-19 氚膘嫚 鞀ろ寣鞚错伂氚膘姢(Spikevax庐)鞐� 雽�頃� 旌愲倶雼� 氤搓贝攵�鞚� 鞀轨澑鞚� 氚涭晿鞙茧┌, 鞚措姅 SARS-CoV-2 LP.8.1 氤�鞚�毳� 響滌爜鞙茧 頃╇媹雼�. 鞚� 氚膘嫚鞚� 靸濏泟 6臧滌洈 鞚挫儊 氇摖 鞐半牴旄奠棎 項堦皜霅橃棃鞀惦媹雼�.
旌愲倶雼� 氚旍澊鞓れ牅臁� 攵勳暭鞚� 欷戩殧頃� 鞚挫爼響滊靹�, 2025雲勳棎 靷毄霅� 氇摖 頂勲Μ頃勲摐(靷爠於╈爠) 欤检偓旮办毄 鞖╇焿鞚� 甑偞鞐愳劀 鞝滌“霅� 鞓堨爼鞛呺媹雼�. 鞚橃暯頀� 鞗愳暋鞚� 韤橂病 霛茧皽鞐� 鞛堧姅 氇崝雮橃潣 鞁犼窚 鞁滌劋鞐愳劀 靸濎偘霅橂┌, 於╈爠路毵堧毽� 瓿奠爼鞚� 鞓儉毽槫欤� 旒�鞛勲笇毽鞚� Novocol Pharma鞐愳劀 靾橅枆霅╇媹雼�. 鞚� 氚膘嫚鞚� 鞚措 鞙犽熃, 鞚茧掣, 鞀れ渼鞀れ潣 鞀轨澑鞚� 氚涭晿鞙茧┌ 鞝� 靹戈硠鞝侅溂搿� 於旉皜 攴滌牅 鞁偓臧� 歆勴枆 欷戩瀰雼堧嫟.
Moderna (NASDAQ:MRNA) a obtenu l'approbation de Sant茅 Canada pour sa version mise 脿 jour du vaccin COVID-19 Spikevax庐, ciblant la variante SARS-CoV-2 LP.8.1. Le vaccin est autoris茅 pour les personnes 脿 partir de six mois.
Marquant une 茅tape importante pour la production biopharmaceutique canadienne, toutes les doses en seringue pr茅remplie pr茅vues pour 2025 seront fabriqu茅es au Canada. La substance m茅dicamenteuse sera produite dans la nouvelle installation de Moderna 脿 Laval, Qu茅bec, tandis que les op茅rations de remplissage-finition seront effectu茅es par Novocol Pharma 脿 Cambridge, Ontario. Le vaccin a d茅j脿 re莽u des autorisations en Europe, au Japon et en Suisse, et d'autres 茅valuations r茅glementaires sont en cours 脿 l'茅chelle mondiale.
Moderna (NASDAQ:MRNA) hat von Health Canada die Zulassung f眉r seine aktualisierte COVID-19-Impfung Spikevax庐 erhalten, die gegen die SARS-CoV-2 LP.8.1-Variante gerichtet ist. Der Impfstoff ist f眉r Personen ab sechs Monaten zugelassen.
In einem wichtigen Meilenstein f眉r die kanadische Bioproduktion werden alle f眉r 2025 vorgesehenen vorgef眉llten Spritzen in Kanada hergestellt. Der Wirkstoff wird in Modernas neuer Anlage in Laval, Qu茅bec, produziert, die F眉ll- und Endbearbeitung 眉bernimmt Novocol Pharma in Cambridge, Ontario. Der Impfstoff wurde bereits in Europa, Japan und der Schweiz zugelassen, und weitere regulatorische Pr眉fungen laufen weltweit.
- First-time domestic production of entire pre-filled syringe format in Canada
- Expanded manufacturing capabilities with new facility in Laval, Quebec
- Regulatory approvals already secured in multiple major markets
- Broad age range approval (six months and older)
- Access through private sector still requires coordination with insurers and payers
Insights
Health Canada approval of Moderna's updated COVID-19 vaccine represents both regulatory progress and manufacturing advancement with domestic production.
Moderna has secured Health Canada authorization for its updated COVID-19 vaccine (Spikevax庐) targeting the LP.8.1 variant, expanding its global regulatory approvals which already include Europe, Japan, and Switzerland. The timing aligns perfectly with the upcoming 2025-2026 vaccination season.
The most significant development is the domestic manufacturing milestone - for the first time, all pre-filled syringe doses for the Canadian market will be produced entirely within Canada. This vertical integration involves drug substance production at Moderna's Laval facility and fill-finish operations at Novocol Pharma in Ontario.
This represents a strategic evolution in Moderna's manufacturing network, reflecting both supply chain resilience and geopolitical considerations. For Canada, this marks significant progress in biomanufacturing sovereignty - a priority that emerged strongly during early pandemic supply challenges.
The approval maintains Moderna's competitive position in the COVID-19 vaccine market alongside Pfizer/BioNTech. While the release doesn't provide specifics on order volumes, the established procurement patterns suggest Canada will purchase sufficient quantities for its public vaccination programs, with provincial authorities determining eligibility.
The dual-channel distribution strategy (public programs and private market access) indicates Moderna is positioning for both government contracts and commercial opportunities, hedging against potential shifts in public funding for COVID-19 vaccines.
All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone
CAMBRIDGE, MA / / August 22, 2025 / Moderna announced today that Health Canada has authorized its updated COVID-19 mRNA vaccine, Spikevax庐, 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 St茅phane 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庐 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 and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Spikevax庐 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
+1 617-800-3651
[email protected]
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]
SOURCE: Moderna, Inc.
View the original on ACCESS Newswire
FAQ
When will Moderna's updated COVID-19 vaccine be available in Canada?
Where is Moderna manufacturing its COVID-19 vaccine in Canada?
Who is eligible for Moderna's updated COVID-19 vaccine in Canada?
How can Canadians access Moderna's updated COVID-19 vaccine?
Which countries have approved Moderna's updated COVID-19 vaccine?
