Moderna Gains Canadian Approval For Updated COVID Vaccine
Health Canada authorizes Spikevax targeting LP.8.1 variant, with all pre-filled syringe doses for 2025 to be produced domestically.
Moderna Inc. (NASDAQ:MRNA) has secured approval from Health Canada for its updated COVID-19 vaccine, Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant. The authorization covers individuals aged six months and older and comes ahead of the planned rollout for the 2025-2026 vaccination season. In a move that bolsters Canada's domestic biomanufacturing capabilities, all pre-filled syringe doses for the Canadian market in 2025 will be produced within the country for the first time.
The company's stock has been under pressure recently, closing down 2.49% at $26.22 on Friday. The shares have seen a significant decline of over 70% in the past year, reflecting waning investor enthusiasm for COVID-19 vaccine makers as the pandemic-era urgency subsides. However, this regulatory milestone in Canada could provide a much-needed tailwind for the biotechnology firm.
"This approval is a regulatory milestone and a testament to Canada's growing leadership in biomanufacturing and public health resilience," stated Stéphane Bancel, Chief Executive Officer of Moderna. The domestic production will be handled at Moderna's new facility in Laval, Quebec, for the drug substance, while fill-finish operations will be managed by Novocol Pharma in Cambridge, Ontario.
The Canadian approval follows similar authorizations for the updated vaccine in other major markets, including Europe, Japan, and Switzerland. The company noted that additional regulatory applications are currently under review globally. The move to localize production in Canada aligns with a broader global trend of building regional manufacturing capabilities to ensure supply chain security for essential medicines, a lesson learned during the early stages of the COVID-19 pandemic.
While the immediate market reaction was subdued, the approval secures a key market for Moderna's updated vaccine and reinforces its position as a leading supplier of COVID-19 immunizations. The company's ability to adapt its mRNA platform to target new variants and secure timely regulatory approvals will be critical to its long-term growth strategy as the world transitions to managing COVID-19 as an endemic disease. Investors will be closely watching sales figures from the upcoming vaccination season to gauge future revenue streams.