Valneva SE announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva's single-dose vaccine, IXCHIQ, for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. The approval was unanimously endorsed by Member States following a stringent assessment by the European Medicines Agency (EMA). The EC decision marks the third approval the Company has received for IXCHIQ following approval from the U.S. Food and Drug Administration (FDA) in November 2023 and Health Canada last month.

The Company expects to deliver the first doses in Europe in the fourth quarter of 2024. IXCHIQ® is the world?s only licensed chikungunya vaccine available to address this unmet medical need. In accordance with the International Recognition Procedure (IRP)3, Valneva has also submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

An additional marketing authorization application is under review by the Brazilian Health Regulatory Agency (ANVISA) to make the vaccine available in certain Low- and Middle-Income Countries (LMIC), with potential approval in 2024. The EC marketing authorization follows the European Medicines Agency?s (EMA) positive opinion a month ago4 and is supported by data from the pivotal Phase 3 study which were published in The Lancet, and showed a 98.9% seroresponse rate at 28 days with a single vaccination. This immune response was sustained for 24 months by 97% of participants and was equally durable in younger and older adults5.

Last month, Valneva reported further positive pivotal data in adolescents six months after a single vaccination, which are intended to support filing for potential label extension for use in adolescents aged 12 to 17 years6. The data are also expected to support licensure of IXCHIQ® in Brazil, which would be the first potential approval for use in an endemic population. Valneva partnered with CEPI and Instituto Butantan in Brazil to make the vaccine more accessible to LMIC.

The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019, which provides funding of up to $24.6 million with support from the European Union?s Horizon 2020 program.