Health Canada has approved Moderna’s updated COVID-19 vaccine, Spikevax, targeting the SARS-CoV-2 LP.8.1 variant for individuals aged six months and older.
The US-based pharmaceutical and biotechnology company plans to supply the vaccine in time for the 2025-2026 vaccination season.
According to Moderna, all Spikevax pre-filled syringe doses for the Canadian market will now be produced domestically.
Moderna’s facility in Laval, Quebec, will manufacture the drug substance, with Novocol Pharma in Cambridge, Ontario, handling fill-finish operations. These doses are anticipated to be available by autumn.
The vaccine has already received approval in Europe, Japan, Switzerland, and other regions. Regulatory submissions in various countries remain under review as preparations continue for the upcoming vaccination season.
Each Canadian province and territory will determine eligibility criteria for public vaccination programmes. Those meeting these criteria will receive the vaccine at no cost, said Moderna.
Moderna CEO Stéphane Bancel said: “This approval is a regulatory milestone and a testament to Canada’s growing leadership in biomanufacturing and public health resilience.
“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.”
Health Canada’s decision was based on extensive data from Moderna, demonstrating the vaccine’s safety and efficacy through clinical and real-world studies.
In July 2025, the European Commission granted marketing authorisation for Spikevax’s updated formulation across all European Union (EU) member states, Iceland, Liechtenstein, and Norway. This decision followed advice from global health authorities recommending vaccines be updated to target the LP.8.1 strain for the 2025-2026 season.
Moderna said that all its vaccines for COVID-19 have generally been well-tolerated. Common local adverse events include injection site pain, while systemic reactions such as headache, fatigue, myalgia, and chills have also been reported.
Earlier this month, the UK Court of Appeal upheld the validity of Moderna’s EP’949 patent. This decision supports the High Court’s July 2024 ruling that the patent is valid and infringed upon by Pfizer/BioNTech’s Comirnaty vaccine.
This makes the UK the first jurisdiction worldwide to affirm the validity of a core mRNA patent from Moderna at a second-instance decision. Pfizer/BioNTech did not contest the infringement finding on appeal.
