Bavarian Nordic A/S, a global vaccine company with a mission to improve health and save lives through innovative vaccines, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Vimkunya (CHIKV VLP vaccine) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older.
After accelerated assessment, the CHMP’s recommendation is primarily based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older and demonstrated a rapid immune response starting to develop within one week. 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. The vaccine was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature.
“The recommendation of our chikungunya vaccine for approval in Europe marks a huge milestone in our efforts to deliver protection against this debilitating disease and, once approved, would represent a significant contribution to expanding the availability of vaccines to a broader population, including adolescents aged 12-17 years,” said Paul Chaplin, president and CEO of Bavarian Nordic. “Chikungunya, like other mosquito-borne illnesses, represents an increasing public health risk across the globe due to factors such as climate change, and we look forward to making the vaccine available for travellers at risk later this year, while also continuing our efforts to expand access to endemic populations across the globe.”
The European Commission, which grants central marketing authorizations in the European Union (EU), will review the CHMP recommendation and is expected to make a final decision in the coming months. If granted, the marketing authorization of Vimkunya would be valid in all EU member states, as well as in Iceland, Liechtenstein, and Norway.
Based on the positive CHMP opinion, Bavarian Nordic will now also submit a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP), with potential approval of the chikungunya vaccine in the UK in the first half of 2025.
The vaccine is also currently under priority review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for February 14, 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, but 30-40% of those affected may develop chronic symptoms that can last for months or even years. In 2024, approximately 480,000 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.
CHIKV VLP is an adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older.
Because VLPs contain no virus genetic material, the vaccine cannot infect cells, reproduce or cause disease.
While the mechanism of action of CHIKV VLP vaccine still needs to be further characterised, it is thought that the vaccine can induce protection from CHIKV infection by inducing neutralising antibodies against certain CHIKV proteins resulting in neutralisation of live virus. An adjuvant is added to increase the magnitude of vaccine-mediated immune responses.
Pending regulatory approval, CHIKV VLP vaccine will be supplied as a single-dose, pre-filled syringe.