Valneva’s Chikungunya Vaccine Candidate Awarded EMA Prime Designation

Saint-Herblain (France), October 16, 2020 – Valneva SE (“Valneva” or “the Company”) a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for its single-shot Phase 3 chikungunya vaccine candidate VLA1553. This new designation from the EMA complements the Fast Track designation received by the U.S. Food and Drug Administration (FDA) in December 2018¹. 

The PRIME designation is awarded by the EMA to promising medicines that demonstrate the potential to address substantial unmet medical need based on initial clinical data. The EMA considers PRIME designations a priority and provides medicine developers with special support, including enhanced interactions and dialogue, as well as a pathway for accelerated evaluation and review².

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We are very pleased to receive PRIME designation for our chikungunya vaccine candidate. It provides further validation of our clinical data and recognition of the significant unmet medical need for chikungunya. We look forward to working closely with the EMA to expedite the availability of our single-shot vaccine to people living in the European Union.”

On September 8, 2020, Valneva announced the initiation of a pivotal Phase 3 clinical trial for VLA1553³, becoming the first company worldwide to advance a chikungunya vaccine candidate into Phase 3.

About Chikungunya
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 4 to 7 days following 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 and rash. 4.1%-78.6% of infections develop into chronic arthralgia (> 3 months). Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The highest 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 have been more than 3 million reported cases in the Americas⁴  and the economic impact is considered to be significant (e.g. Colombia outbreak 2014: $73.6 million⁵). The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to further spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.