Moderna Stock Rises on Approval of Updated COVID-19 Vaccine in Canada

Moderna shares are trading higher after receiving Health Canada approval for its updated COVID-19 vaccine, targeting the SARS-CoV-2 LP.8.1 variant. The vaccine will be manufactured domestically in Canada for the first time, with doses expected to be available this fall. The vaccine has already been approved by regulators in Europe, Japan, and other countries, with additional applications under review.

Moderna Inc. (NASDAQ: MRNA) saw its shares trading higher following the news that Health Canada has approved its updated COVID-19 vaccine, Spikevax®, targeting the SARS-CoV-2 LP.8.1 variant. The vaccine has been authorized for individuals aged six months and older, and it will be manufactured domestically in Canada for the first time. Doses are expected to be available this fall, marking a significant milestone in Canadian biomanufacturing [1].

The approval comes after a comprehensive review by Health Canada, which considered clinical, non-clinical, and real-world data supporting the vaccine's safety and efficacy. 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 [1].

Moderna's updated vaccine has already received approvals in Europe, Japan, and Switzerland. Additional regulatory applications are under review around the world in preparation for the upcoming 2025-2026 vaccination season. The dual-channel distribution strategy, which includes both public programs and private market access, indicates Moderna is positioning for both government contracts and commercial opportunities [2].

The approval maintains Moderna's competitive position in the COVID-19 vaccine market alongside Pfizer/BioNTech. The domestic manufacturing milestone is a strategic evolution in Moderna's manufacturing network, reflecting both supply chain resilience and geopolitical considerations. Canada's progress in biomanufacturing sovereignty is a priority that emerged strongly during early pandemic supply challenges [2].

While the release does not provide specifics on order volumes, the established procurement patterns suggest Canada will purchase sufficient quantities for its public vaccination programs. Provincial authorities will determine eligibility for the vaccine, with those who meet provincial criteria receiving it free of charge. Efforts are ongoing with private insurers and payers to streamline access and reimbursement within the private sector [1].

References:
[1] https://finance.yahoo.com/news/moderna-receives-health-canada-approval-132500068.html
[2] https://www.stocktitan.net/news/MRNA/moderna-receives-health-canada-approval-for-updated-covid-19-vaccine-ng7wqy4nb3gy.html