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Tuesday, April 16th, 2024

FDA grants breakthrough therapy designation to Valneva’s Chikungunya vaccine candidate

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A chikungunya vaccine candidate created by Valneva SE is proceeding through the U.S. Food and Drug Administration (FDA) pipeline, having been awarded a breakthrough therapy designation this week after already gaining fast track designation.

A single shot therapy, the vaccine — known as VLA1553 — began testing in a Phase 3 trial in April 2021. Data from that trial is expected to emerge later this summer and will focus on evaluating its immunogenicity and safety at 28 days from immunization. The shot is a live-attenuated candidate designed by deleting a part of the chikungunya virus genome.

“We are extremely pleased with FDA’s recognition of VLA1553 as a Breakthrough program,” Valneva Chief Medical Officer Juan Carlos Jaramillo said. “Chikungunya is a major, growing public health threat, and VLA1553 targets long-lasting protection against the chikungunya virus with a single shot. We will continue to work closely with the FDA to bring a preventative solution to the market as soon as possible.”

The mosquito-borne disease known as chikungunya comes from the chikungunya virus, which has spread to more than 100 countries worldwide. It typically leads to symptomatic disease four to seven days after a bite. While the disease comes with low mortality, it does inflict plenty of pains, including acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia. With climate change fueling the spread of mosquitoes geographically, its reach is only expected to grow with time.

FDA’s designations of VLA1553 are meant to help hasten development and review, spurred by positive preliminary clinical data. Presently, no vaccines or effective treatments for chikungunya exist. Eventually, Valneva plans to commercialize its new vaccine, if approved. Abroad, the candidate has also received PRIME designation from the European Medicines Agency.