Chikungunya Vaccine Is On The FDA’s Fast-Track
A French vaccine manufacturer announced that an End Of Phase 2 (EOP2) meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on February 24, 2020, for its single-shot chikungunya vaccine candidate, VLA1553.
Valneva SE said it plans to present to the FDA its plan for Phase 3 clinical studies and licensure.
During November 2019, Valneva reported final Phase 1 results confirming VLA1553’s excellent immunogenicity and safety profile.
The Company says it has completed all required non-clinical studies requested by the FDA.
VLA1553 is a monovalent, single dose, live-attenuated vaccine candidate for protection against chikungunya and was granted Fast Track designation by the FDA in December 2018 and may be eligible for a Priority Review Voucher.
This is positive news since there are no preventive vaccines or effective treatments available for Chikungunya.
As of December 5, 2019, a total of 115 chikungunya virus disease cases with illness onset in 2019 have been reported by 26 U.S. states. All reported cases occurred in travelers returning from affected areas. However, there have been 2 locally-acquired Chikungunya cases reported from Puerto Rico.
And on January 3, 2020, the US Centers for Disease Control and Prevention (CDC) issued a Level 1 Travel Alert regarding an outbreak of chikungunya in Ethiopia.
Wolfgang Bender, M.D., Ph.D., chief medical officer of Valneva, commented in a press release, “We are extremely pleased that the FDA has accepted our proposal for an EOP2 meeting.
Subject to the outcome we may commence Phase 3 clinical trials within a few months.”
“We are strongly committed to advancing VLA1553, currently the only chikungunya vaccine candidate in clinical development showing fully sustained titers one year after a single vaccination, through the accelerated approval.”
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes, says the US Centers for Disease Control and Prevention (CDC).
The Chikungunya virus causes clinical illness in 72-92 percent of infected humans around 4 to 7 days after an infected mosquito bite.
Complications resulting from the disease include visual, neurological, heart and gastrointestinal manifestations; fatalities have been reported (case fatality rates of 0.1% to 4.9% from epidemics) in elderly patients at higher risk.
The VLA1553 vaccine candidate is designed for prophylactic, active, single-dose immunization against Chikungunya in humans over 1-year-old. The vaccine targets long-lasting protection and an anticipated safety profile similar to licensed vaccines for active immunization in adults and children.
VLA1553 is based on an infectious clone (CHIKV LR2006-OPY1) attenuated by deleting a major part of the gene encoding the non-structural replicase complex protein nsP3, aiming for protection against various Chikungunya virus outbreak phylogroups and strains.
Valneva SE is a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs. More information is available at Valneva.
Chikungunya vaccine news published by Vax-Before-Travel.