HQ Team
June 13, 2023: Valneva SE, a French vaccine maker, announced that its last-stage trials for its single-shot chikungunya registered a 98.9% vaccination success rate.
The experimental drug, VLA1553, is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway, according to a company statement.
A Biologic License Application is currently under priority review by the US Food and Drug Administration with a Prescription Drug User Fee Act review goal date at the end of August 2023,
A regulatory application has also been filed with Health Canada. If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.
Both young and old
“The phase III results showed that VLA1553 demonstrated a very high seroresponse rate of 98.9% in participants 28 days after receiving the single administration,” according to the statement.
This immunogenicity profile was similar in both younger and older adults, and 96% of participants maintained seroresponse six months after vaccination.
Serology is the scientific study or diagnostic examination of blood serum, especially with regard to the response of the immune system to pathogens or introduced substances.
VLA1553 was generally safe and equally well tolerated in younger and older adults, the company stated.
Data availability
“More detailed results on our single-shot chikungunya vaccine candidate are now available to the scientific and broader public health communities.” Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said.
Valneva reported positive twelve-month persistence data in December 2022. A clinical study of VLA1553 in adolescents is ongoing in Brazil, for which Valneva reported enrollment and vaccination completion in February 2023.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus transmitted by Aedes mosquitoes.
The infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite.
While mortality with the disease is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032, the company stated.
Acute fever
Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia.
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 high-risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia.
The virus has spread to more than 110 countries.
As of July 2022, more than three million cases have been reported in the Americas and the economic impact is considered to be significant.
FDA Fast Track
Currently, there are no preventive vaccines or effective treatments available.
If approved, Valneva intends to commercialize the vaccine, leveraging its existing manufacturing and commercial operations.
Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing, and marketing of the vaccine.
The vaccine received FDA Fast Track, Breakthrough Therapy designations, and Priority Review in 2018, 2021 and 2023.
