Denmark-based vaccines company Bavarian Nordic A/S (CPH:BAVA) announced on Tuesday that Health Canada has accepted its New Drug Submission for CHIKV VLP, a single-dose chikungunya vaccine candidate for individuals aged 12 and older.

The acceptance confirms a complete submission and initiates a standard review procedure.

Regulatory approval in Canada could follow in the first half of 2026. The submission is supported by data used for recent approvals in the United States, European Union and United Kingdom.

Clinical data include results from two phase 3 trials involving over 3,500 healthy participants. The vaccine induced neutralising antibodies in up to 97.8% of individuals aged 12 to 64, and 87.3% in those over 65, by day 21 post-vaccination.

Secondary endpoints showed rapid immune response beginning within 8 to 15 days after vaccination. The vaccine was well-tolerated, with mild to moderate adverse events such as injection site pain, fatigue, headache and muscle pain.

CHIKV VLP does not contain viral genetic material, making it non-infectious and broadly suitable for use.

Pending approval, the vaccine will be made available in a prefilled syringe.