This Mosquito-borne Viral Disease May Soon Be Prevented with an Innovative Vaccine
After many years of focused research, an innovative vaccine candidate may become available in 2023 to combat the chikungunya virus, which has spread to over 120 countries.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV) transmitted to humans by a bite from Aedes mosquitoes.
The U.S. CDC says a CHIKV infection leads to symptomatic disease in 72-92% of humans after a few days.
While mortality is low, CHIKV morbidity is high.
This disease can impact over 30% of the population in areas where CHIKV is circulating.
While no vaccine or specific treatments are available for this debilitating disease today, France-based Valneva SE announced very encouraging news on August 18, 2022.
Valneva announced that it had initiated a rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), seeking approval of the VLA single-shot VLA1553 chikungunya vaccine candidate in persons aged 18 years and above.
Once all portions of the BLA have been submitted, and if the filing is accepted, the FDA will determine priority review eligibility and Action Date.
This new BLA submission is part of the approved accelerated pathway agreed upon with the FDA in 2020.
The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively.
VLA1553 was also granted PRIority MEdicine designation by the European Medicines Agency in 2020.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented in a related press release, "This is an extremely important milestone for our VLA1553 program."
"And we are very proud to be the first company worldwide that has begun submission of a BLA for a chikungunya vaccine candidate."
"Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease."
"We will continue to work assiduously to bring VLA1553 to market as soon as possible."
To make VLA1553 more accessible to Low- and Middle-Income Countries, Valneva previously initiated funding and distribution agreements.
The high-risk areas of infection for travelers are places where CHIKV-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia.
As of July 2022, more than three million cases have been reported in the Americas.
Beginning in 2014, CHIKV disease cases were reported among returning U.S. travelers, and local transmission was identified in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands.
In addition to VLA1553, other chikungunya vaccine candidates are investigating various technologies focusing on optimizing the balance between immunogenicity and safety.
On June 23, 2022, Dr. B Bell and Dr. S Hills presented to the U.S. CDC's vaccine committee: Overview of chikungunya and chikungunya vaccines; Plans and timeline for workgroup activities.
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