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Valneva SE have announced that the European Medicines Agency (EMA) has performed a technical validation of the Marketing Authorisation Application for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and has determined that all essential regulatory elements required for scientific assessment were included in the application.
The MAA was granted accelerated assessment last month by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
Accelerated assessment reduces the timeframe for EMA’s CHMP to review a MAA once it is accepted for review from 210 days under the standard review procedure to 150 days. This does not, however, include clock stops when applicants must provide additional information during the review process, which is common in review procedures.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s MAA review acceptance and will work closely with them to bring VLA1553 to market. Chikungunya virus, or CHIKV, has already spread to over 110 countries and the risk of chikungunya spreading in Europe is relatively high due to the possibility of infected travellers. No vaccine or specific treatments are currently available for this debilitating disease which therefore constitutes an unmet medical need. Following approval of VLA1553 in the United States, we will continue to work diligently to bring VLA1553 to other territories as soon as possible.”
VLA1553 received approval from the U.S. Food and Drug Administration (FDA) at the beginning of the month under the brand name IXCHIQ. In the U.S., the vaccine 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 to CHIKV.
Mid-November, Valneva also reported positive pivotal Phase 3 immunogenicity data in adolescents for VLA1553 which are intended to support label extension in this age group. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations.