PXVX-0317

The US Food and Drug Administration (FDA) has approved Bavarian Nordic’s chikungunya vaccine Vimkunya for use in individuals aged 12 years and older. The chikungunya virus has emerged across several regions in Asia, Africa and the Americas, including many popular travel destinations, in the past 20 years, with approximately 620,000 cases reported globally in 2024. The mosquito-borne viral disease causes fever, rash, fatigue, headache and often severe joint pain. While the majority of patients make a full recovery, some may develop chronic symptoms that can last for months or even years. Valneva’s Ixchiq became the world’s first licensed chikungunya vaccine in November 2023 after it was approved by the FDA for use in adults. However, Bavarian Nordic’s Vimkunya is now the first chikungunya to be approved by the regulator for those as young as 12 years, which the company said “[addresses] an unmet need for chikungunya prevention for younger travellers”. The FDA’s decision on Vimkunya was supported by positive results from two late-stage clinical trials, in which the vaccine induced neutralising antibodies in up to 97.8% of 3,500 healthy individuals aged 12 years and older 21 days after vaccination. Vimkunya also demonstrated a rapid immune response from as early as week one and was well tolerated across both studies. Bavarian Nordic’s president and chief executive officer, Paul Chaplin, said: “As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travellers and vulnerable populations. “We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.” The company said it is “on track” for the commercial launch of Vimkunya in the US in the first half of 2025. The authorisation comes less than three weeks after Vimkunya was recommended by the European Medicines Agency’s human medicines committee, also for use in individuals aged 12 years and older. The European Commission will now review the recommendation as it makes a final decision on the vaccine, which is expected in the coming months.

First chikungunya vaccine approved for persons as young as 12 years old, addressing an unmet need for chikungunya prevention for younger travelers. On track for commercial launch in the U.S. in the first half of 2025. A Tropical Disease Priority Review Voucher was awarded to the Company upon approval. February 14, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Food and Drug Administration (FDA) has approved VIMKUNYA™ (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older. The FDA approved VIMKUNYA under Priority Review, based on 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 and demonstrated a rapid immune response starting to develop within one week. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature1. VIMKUNYA is a VLP vaccine, which means that it uses virus-like particles designed to mimic the chikungunya virus without the ability to infect cells, replicate or cause disease. “The approval of our chikungunya vaccine is a testament to our unwavering commitment to addressing unmet medical needs and protecting communities worldwide,” said Paul Chaplin, President and CEO of Bavarian Nordic. “As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travelers and vulnerable populations. We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.” Concurrent with the approval, the FDA awarded Bavarian Nordic a Priority Review Voucher (PRV) under the Tropical Disease PRV program, which the Company intends to monetize when appropriate. Bavarian Nordic aims to provide commercial availability of VIMKUNYA in the U.S. in the first half 2025. The vaccine recently received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and will also be launched in key European markets in the first half of 2025, pending adoption of a final decision on the marketing authorization by the European Commission. 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 years2. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that can last for months or even years3. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide4. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile5. VIMKUNYA is a vaccine for prevention of disease caused by chikungunya virus in people 12 years of age and older. Additional clinical studies are required to confirm the clinical profile of VIMKUNYA, and confirmatory efficacy studies are also planned as part of the post-marketing commitments and requirements as agreed with the FDA. VIMKUNYA is supplied as a single-dose 1-mL glass pre-filled syringe with 0.8 mL dose volume. Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com 1 VIMKUNYA Prescribing Information 2025 2 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. https://www.cdc.gov/chikungunya/data-maps/index.html. Accessed February 14, 2025. 3 European Centre for Disease Prevention and Control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-disease. Accessed February 14, 2025. 4 European Centre for Disease Prevention and Control. Chikungunya worldwide overview. https://www.ecdc.europa.eu/en/chikungunya-monthly. Accessed February 14, 2025. 5 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID: PMC11070701. The content above comes from the network. if any infringement, please contact us to modify.