Chikungunya, EMA seeks approval for new vaccine

The European Medicines Agency (EMA) has recommended the authorisation of the marketing of ‘Vimkunya,’ the first vaccine in the European Union (EU) to protect adolescents aged 12 and over against Chikungunya. The vaccine will be administered as a single dose. The EMA’s PRIority MEdicines (PRIME) programme facilitated the accelerated development of ‘Vimkunya’, a medicine considered to be of major public health interest. These products are subject to a priority regime for marketing applications to the Committee for Medicinal Products for Human Use (CHMP). The CHMP has requested a post-authorisation efficacy study to confirm the efficacy of ‘Vimkunya’ in preventing Chikungunya in adolescents and adults. The CHMP’s opinion is crucial in determining the availability of this new vaccine to patients. The opinion will subsequently be conveyed to the European Commission for deliberation on a potential EU-wide marketing authorisation. Chikungunya is a viral disease caused by the Chikungunya virus (CHIKV), transmitted to humans by infected mosquitoes. Chikungunya is not endemic in Europe. It primarily affects populations in tropical and subtropical regions, with the majority of EU cases being reported in travellers who have contracted the infection outside of continental Europe. From January 1 to December 3, 2024, 15 cases of Chikungunya fever were recorded in Italy by the national surveillance system ‘Epicentro,’ overseen by the Istituto Superiore di Sanità.