Health Canada Clears Moderna’s LP.8.1 COVID Shot, First Fully Made in Canada

Health Canada has authorized Moderna’s updated Spikevax COVID-19 vaccine that targets the SARS-CoV-2 LP.8.1 variant for use in people aged six months and older, the company said Friday. Moderna plans to supply Canada with domestically produced, pre-filled syringe doses for the 2025-2026 vaccination campaign. Drug substance will come from the firm’s new Laval, Quebec, facility, with fill-finish work handled by Novocol Pharma in Cambridge, Ontario, marking the first time the country’s entire Spikevax pre-filled format will be manufactured at home. The Canadian clearance follows similar authorizations in Europe, Japan and Switzerland. Moderna said it remains on schedule to deliver the updated shots ahead of the coming respiratory-virus season while it seeks additional regulatory approvals worldwide.