Bavarian Nordic’s chikungunya vaccine Vimkunya is one step closer to being available in Europe after having secured an European Medicines Agency (EMA) recommendation for a marketing authorisation.
If authorised, Vimkunya would be the first vaccine in the EU to protect individuals aged 12 and older against chikungunya, a mosquito-borne disease that leads to fever and joint pain. While most patients recover within a week, some experience prolonged joint pain, and a small percentage develop severe complications, including multiorgan failure.
Bavarian Nordic is now catching up to Valneva, whose Ixchiq vaccine became the world’s first licensed chikungunya vaccine when it was approved by the US Food and Drug Administration (FDA) in November 2023. The EMA followed suit and approved the vaccine in the EU in July 2024. Valneva has since applied to extend Ixchiq’s approval to adolescents in both the EU and US. Meanwhile, Bavarian Nordic’s vaccine is under priority review with the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for 14 February 2025.
Chikungunya is mainly found in tropical and subtropical regions, with most EU cases linked to travellers who contract the virus abroad. While the disease is not an endemic in Europe, isolated cases of local transmission have occurred, particularly in Southern Europe, where mosquitoes capable of spreading the virus are present. The EMA has noted that climate change-could allow these mosquitoes to spread into new areas, potentially increasing the risk of outbreaks in regions that have so far remained unaffected.
This announcement comes one day after World Neglected Tropical Diseases Day (30 January), during which the World Health Organization (WHO) highlighted 21 tropical diseases that continue to pose significant health risks. Chikungunya remains on that list, with WHO director-general Dr. Tedros Adhanom Ghebreyesus emphasising ongoing challenges in addressing these diseases, including funding shortages, service disruptions, and climate change,
The EMA’s Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on data from two Phase III placebo-controlled clinical trials enrolling over 3,500 participants. The trials assessed the immune response and safety of Vimkunya across different age groups, with efficacy evaluated based on the presence of neutralising antibodies. In the main study (NCT05072080), 96.6% of vaccinated participants showed a seroresponse by day 22, with immunity still detectable in 84% of participants at six months. The CHMP has requested a post-authorisation study to further assess Vimkunya’s effectiveness in adolescents and adults.
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By GlobalDataMarket forecasts suggest that Vimkunya could generate $146m in sales by 2030 if it were to secure approval, while Ixchiq is expected to reach $238m in the same year, according to GlobalData’s Pharma Intelligence Center.
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