Valneva has secured marketing authorisation from the European Commission (EC) for IXCHIQ, a single-dose vaccine for preventing chikungunya.
IXCHIQ is the world’s first vaccine against the chikungunya virus and is indicated for usage in people aged 18 years and older.
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The development follows unanimous endorsement by EU member states and a positive opinion from the European Medicines Agency (EMA).
The approval is underpinned by data from the Phase III clinical trial, which demonstrated a 98.9% seroresponse rate at 28 days after a single vaccination.
This immune response was maintained at 97% for 24 months and was consistent across age groups.
In June 2024 Valneva reported further positive data in adolescents six months after a single vaccination.
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By GlobalDataThese findings aim to support a potential label extension for use in adolescents aged 12 to 17 years.
The EC’s decision represents the third authorisation for IXCHIQ, following approvals from the US Food and Drug Administration (FDA) in November 2023 and by Health Canada in June 2024.
Valneva anticipates the initial delivery of vaccine doses in Europe in the fourth quarter of 2024
The company has submitted a marketing authorisation application to the UK Medicines and Healthcare products Regulatory Agency under the International Recognition Procedure.
An application for the vaccine is being reviewed by the Brazilian Health Regulatory Agency with potential approval anticipated during 2024.
To enhance the vaccine’s accessibility in low and middle-income countries Valneva has collaborated with CEPI [the Coalition for Epidemic Preparedness Innovations] and the Instituto Butantan in Brazil.
This collaboration is part of an agreement entered in July 2019, which includes funding of up to $24.6m, supported by the European Union’s Horizon 2020 programme.
Valneva chief medical officer Juan Carlos Jaramillo stated: “The EC approval marks a crucial milestone toward making this vaccine available to as many European citizens as possible.
“It is critical to provide a vaccine solution not only to European travellers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks.”
