Moderna's COVID-19 Vaccine Clears Canadian Approval, Shares Surge 5%

Moderna's stock surged over 5% after Canada approved its COVID-19 vaccine, Spikevax. The vaccine will be manufactured domestically in Canada and is expected to be available for the 2025-2026 vaccination season. Moderna's Q2 sales dropped 41.1% YoY to $142 million, but the company expects demand to increase in the second half of the year. The approval is a regulatory milestone and a testament to Canada's growing leadership in biomanufacturing.

Moderna's stock surged over 5% after Health Canada approved its updated COVID-19 vaccine, Spikevax®. The vaccine targets the SARS-CoV-2 LP.8.1 variant and is authorized for individuals aged six months and older. This approval marks a significant milestone for Canadian biomanufacturing, as 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 approval aligns with Moderna's global regulatory strategy, with the vaccine already approved in Europe, Japan, and Switzerland. This domestic manufacturing milestone signifies a strategic evolution in Moderna's manufacturing network, reflecting both supply chain resilience and geopolitical considerations. For Canada, this represents significant progress in biomanufacturing sovereignty, a priority that emerged strongly during early pandemic supply challenges.

Moderna's Q2 sales dropped 41.1% year-over-year (YoY) to $142 million, primarily due to reduced COVID-19 vaccine shipments. However, the company expects demand to increase in the second half of the year, driven by the approval of the updated vaccine and the upcoming 2025-2026 vaccination season. The approval maintains Moderna's competitive position in the COVID-19 vaccine market alongside Pfizer/BioNTech.

Eligibility for the public vaccination program is set by each province and territory, with those who meet provincial criteria receiving the vaccine free of charge. For individuals not covered under public programs, efforts are ongoing with private insurers 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.

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]. This approval represents both regulatory progress and manufacturing advancement with domestic production.

References:
[1] Moderna Canada. SPIKEVAX® Product Monograph. August 21, 2025. [https://www.modernatx.com](https://www.modernatx.com)