All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone

CAMBRIDGE, MA / ACCESS Newswire / August 22, 2025 / Moderna announced today that Health Canada has authorized its updated COVID-19 mRNA vaccine, Spikevax®, 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 Stéphane 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.