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Bavarian Nordic A/S, a global vaccine company, announced that Health Canada has accepted for review the company’s application for licensure of the single-dose, virus-like particle (VLP) chikungunya vaccine candidate, CHIKV VLP, for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. The application screening acceptance by the Directorate confirms that the New Drug Submission is complete and begins a standard review procedure, potentially supporting approval of the vaccine in the first half of 2026.
The New Drug Submission is based on the data, which also supported the recent US, EU and UK approvals of the vaccine, including results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65 year olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12-64 year old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain.
Paul Chaplin, president and CEO of Bavarian Nordic, said: “The regulatory submission and acceptance by Health Canada represents yet another highlight in our efforts to expand access to our chikungunya vaccine across the globe. Pending approval, this vaccine will further strengthen our offering for Canadians seeking protection against serious diseases when traveling the world.”
CHIKV VLP is a vaccine for the prevention of chikungunya disease in individuals aged 12 years and above. It is designed to induce a robust seroresponse, with protective immunity starting to develop as early as 1 week after vaccination. Pending regulatory approval, CHIKV VLP vaccine will be available in a prefilled syringe.
CHIKV VLP does not contain viral genetic material and is therefore non-infectious and unable to cause disease, ensuring a broad range of people can benefit from vaccination.
The vaccine was approved by the US Food and Drug Administration (FDA) and the European Commission in February 2025.
Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile.
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. The company is a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines.
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