Moderna has secured approval from Health Canada for Spikevax, its updated Covid-19 mRNA vaccine, which targets the SARS-CoV-2 LP.8.1 variant.
This vaccine is authorised for individuals aged six months and above.
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The company plans to ensure the updated vaccine is ready for distribution in time for the 2025-2026 vaccination season.
All pre-filled syringe (PFS) doses of the vaccine for Canada will be produced domestically, according to the company.
Moderna will manufacture the drug substance at its new facility located in Laval, Quebec, while the fill-finish operations will be conducted by Novocol Pharma in Ontario.
The doses are anticipated to be available this fall.
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By GlobalDataHealth Canada’s decision to authorise the vaccine was based on a set of evidence provided by Moderna, which included clinical, non-clinical and real-world data demonstrating the efficacy and safety of Spikevax.
Moderna CEO Stephane 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.”
The updated vaccine targeting the LP.8.1 variant has also received approval from regulatory bodies in Europe, Switzerland, Japan and several other nations.
Additional regulatory submissions are currently under review globally in anticipation of the upcoming vaccination season.
In June this year, the US Food and Drug Administration (FDA) expanded the approval of Moderna’s respiratory syncytial virus (RSV) vaccine to include younger adults at risk.
However, it remains unclear if the vaccine will be recommended for broader use in the national immunisation schedule.
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