As reported in World Pharmaa Today, Valneva  SE is a specialty vaccine company in the business of the creation and distribution of prophylactic vaccines that treat infectious diseases with serious unmet needs.

Now, their single-shot vaccine to treat the Chikungunya virus has been awarded Breakthrough Therapy Designation by the FDA. The designation is designed to expedite patient access to promising drug candidates that meet significant unmet needs that preliminary data suggests are substantially more effective at meeting certain key endpoints than available options. The designation is meant to speed up to process of rare drug development for the most necessary and promising of treatment candidates.

Chikungunya is a viral disease spread by mosquitoes, that causes 72-92% of people to develop an infection 4-7 days following a bite from Aedes mosquitos. The mosquito-borne disease, a type of Togaviridae virus, causes people to develop a fever, severe joint and muscle pain, headaches, nausea, rashes, and chronic arthralgia. While people don’t typically die of the disease, it’s extremely infectious. It infects most people with bites, tending to cause spontaneous large outbreaks, with about 1/3 to 3/4 of the population enduring symptoms in infected areas, occurring in parts of the Americas, Africa, and Southeast Asia.

Right now, there are no preventative measures or vaccines available, nor effective treatments. As such, the medical community considers the cost high, and deem the virus a major risk to public health.

The team is very pleased with the new boost from the FDA, which will allow their trials to proceed immediately. As of April 2021, they completed recruiting patients for the next pivotal step, the Phase 3 trial, VLA1553-301, which will be evaluating the shot’s immunogenicity and safety.

The company’s chief medical officer, Juan Carlos Jaramillo said,