Research & Development
EMA accepts Valneva's chikungunya vaccine application for accelerated assessment
27 November 2023 -

Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) reported on Monday that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for its single-shot chikungunya vaccine candidate VLA1553.

The MAA has been granted accelerated assessment by EMA's Committee for Medicinal Products for Human Use (CHMP) due to the vaccine's potentially significant public health impact and therapeutic innovation. This designation shortens the review period from 210 to 150 days, excluding clock stops for additional information, which is standard in such procedures.

Recently approved by the US Food and Drug Administration (FDA) as IXCHIQ for individuals aged 18 and older at risk of chikungunya virus exposure, VLA1553 is indicated for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure. Valneva reported positive Phase 3 immunogenicity data in adolescents in mid-November, intended to support label extension in this age group. The trial is also crucial for potential licensing in Brazil, which would be the first potential approval for use in endemic populations.

Chikungunya, a mosquito-borne viral disease transmitted by Aedes mosquitoes, causes high morbidity rates with acute fever, joint and muscle pain, headache, nausea and rash.