Pharma Focus Asia

FDA Accepts Valneva’s Chikungunya Vaccine Licence Application for Priority Review

Monday, February 20, 2023

Valneva announced that the U.S. Food and Drug Administration (FDA) has completed a filing review of its Biologics Licence Application for Valneva’s single-shot chikungunya vaccine candidate VLA1553 and determined that the application is sufficiently complete to permit a substantive review.

VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, spreading to over 100 countries. It is designed by deleting a part of the chikungunya virus genome.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553.

If approved, VLA1553 will expand Valneva’s existing commercial vaccines portfolio and, Valneva intends to commercialise this vaccine, leveraging its existing manufacturing and commercial operations.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

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