Health
Bavarian Nordic Receives Acceptance from Health Canada for Review of the New Drug Submission for its Chikungunya Vaccine
COPENHAGEN, Denmark, July 22, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today 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
About this update from Bavarian Nordic A/s
[{"type":"image","alt":"Bavarian Nordic A/S","displaySize":"","headline":null,"caption":"Bavarian Nordic A/S","className":"","disableSlideshowImg":false,"size":{"original":{"width":224,"height":118,"url":"https://media.zenfs.com/en/globenewswire.com/8b66f55ff95ddf48491741d682cbdfa0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/X7d037B4FI93H1mEWMcPsw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIyMTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/8b66f55ff95ddf48491741d682cbdfa0","width":224,"height":118}},"lazy":false},{"type":"horizontalRule"},{"type":"text","content":"COPENHAGEN, Denmark, July 22, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today 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.","length":591,"tagName":"p"},{"type":"text","content":"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 pain1,2.","length":892,"tagName":"p"},{"type":"text","content":"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...