Specialty vaccine company Valneva announced that the US Food and Drug Administration (FDA) has completed a submission review of its Biological License Application for chikungunya vaccine candidate VLA1553. of a single injection of Valneva and determined that the application is sufficiently complete to allow for substantive review. The review classification is Priority .
VLA1553 has been assigned a Prescription Drug User Fee Act (PDUFA) review target date of late August 2023, which is the date the FDA intends to take action on the application. FDA recognition of submission does not mean that a license will be granted, nor does it represent any evaluation of the adequacy of the data submitted.
VLA1553 is an investigational single-dose live attenuated vaccine candidate against chikungunya virus, which has spread to more than 100 countries. It has been designed by eliminating a part of the chikungunya virus genome.
About Chikungunya Chikungunya is a mosquito-borne viral disease caused by chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Chikungunya virus often causes large sudden outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus circulates. There are no preventative vaccines or effective treatments available and, as such, chikungunya is considered a major public health threat. As of July 2022, there were more than 3 million cases reported in the Americas and the economic impact is considered significant. The medical and economic burden is expected to increase as the primary mosquito vectors of CHIKV continue to spread geographically. Infection leads to symptomatic illness in up to 97% of humans after three to seven days after the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia. It is estimated that more than three-quarters of the world’s population lives in areas at risk of CHIKV transmission. High-risk areas for infection are places where mosquitoes carrying the chikungunya virus are currently endemic, including the Americas, parts of Africa, and Southeast Asia. |
About VLA1553
VLA1553 is an investigational single-dose live attenuated vaccine candidate against chikungunya virus, which has spread to more than 100 countries. It has been designed by eliminating a part of the Chikungunya virus genome.
To make VLA1553 more accessible to low- and middle-income countries (LMICs), Valneva and the Butantan Institute in Brazil signed an agreement in January 2021 for the development, manufacturing and commercialization of VLA1553. The collaboration is part of the agreement signed between CEPI and Valneva in July 2019, which provides for financing of up to $24.6 million with the support of the European Union’s Horizon 2020 program.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022[5], final batch-to-batch consistency results in May 2022[6], and positive twelve-month persistence data in December 2022 .
If approved, VLA1553 would expand Valneva’s existing commercial vaccine portfolio and, as such, Valneva intends to commercialize this vaccine, leveraging its existing commercial and manufacturing operations.
