French speciality vaccine company Valneva has announced that its single-shot chikungunya vaccine candidate has received a breakthrough therapy designation from the US Food and Drug Administration (FDA).
The chikungunya vaccine – VLA1553 – has also previously been awarded an FDA fast track designation and a European Medicines Agency (EMA) PRIME designation, in December 2018 and October 2020 respectively.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus. Although the mortality with chikungunya virus is low, morbidity is high, with clinical symptoms including acute onset of fever, debilitating joint and muscle pain, headache, rash, nausea and chronic arthralgia.
The high-risk areas of infection include the Americas, parts of Africa and Southeast Asia. Currently, no preventative vaccines or effective treatments are available for the virus, making it a major public health threat.
“We are extremely pleased with FDA’s recognition of VLA1553 as a breakthrough programme,” said Juan Carlos Jaramillo, chief medical officer of Valneva.
“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,” he added.
In April 2021, Valneva announced that it has completed recruitment for a pivotal Phase III trial of VLA1553-301, which is expected to report topline data this summer.