Valneva’s chikungunya vaccine reports positive topline data from Phase 3 trial

Drugs

There are no preventive vaccines or effective treatments available for chikungunya.

Valneva’s vaccine, which was recently awarded Breakthrough Designation status by the US Food and Drug Administration (FDA), expects final trial results in the next six months once the trial has completed a final analysis including 6 months of safety data.

The candidate has also received FDA Fast Track designation (December 2018) and the European Medicines Agency’s PRIME designation (October 2020). The sponsor of the first chikungunya vaccine approved in the US will be eligible to receive a Priority Review Voucher (granting priority review for a subsequent application that does not already qualify for priority review).

Chikungunya impact expected to grow

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae​​virus, transmitted by Aedes​​ mosquitoes.

Infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high.

The high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia. As of September 2020, there were more than 3 million reported cases in the Americas: with the impact expected to grow as mosquitos carrying the virus continue to spread geographically.

Valneva’s vaccine is a live-attenuated, single-dose vaccine candidate: which has been designed by deleting a part of the chikungunya virus genome.

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