November 10, 2023
2 minute read
Important points:
- The FDA has approved a chikungunya vaccine for people 18 and older who are at high risk of exposure to the virus.
- The CDC committee is expected to vote on a vaccine recommendation in February.
The FDA has approved the world’s first vaccine against chikungunya virus.
The vaccine, Valneva’s Ixyk, has been approved for people over 18 who are at high risk of being exposed to chikungunya, which is spread through the bite of an infected person. Aedes Mosquitoes similar to dengue fever and Zika fever. According to the company, a clinical study conducted with adolescents aged 12 to 17 is ongoing.
According to the WHO, chikungunya was first identified in Tanzania in 1952, and the first urban outbreaks were recorded in Thailand and India in the late 1960s and 1970s.
The virus was not detected in U.S. travelers until 2006, and no local cases were reported until 2014, when 12 local infections occurred in Florida and Texas and spread to Puerto Rico and the U.S. Virgin Islands. There have been more than 4,600 cases in the U.S. territory, including the United States.
“Chikungunya virus infection can cause serious illness and long-term health problems, especially for older adults and people with underlying health conditions.” Peter Marks, MD; The director of the FDA’s Center for Biologics Evaluation and Research said in a press release: “[This] This approval addresses an unmet medical need and represents an important advance in the prevention of a potentially debilitating disease for which treatment options are limited. ”
In August, the FDA extended the review period for the vaccine by three months to allow Valneva to finalize plans for a Phase 4 postmarket safety monitoring study required as part of the accelerated approval process.
Phase 3 trial data showing that the single-dose live attenuated vaccine demonstrated a 98.9% seroreactivity rate 28 days after vaccination and maintained a 96.3% seroreactivity rate 6 months after vaccination. Approved based on.
Experts have long warned that climate change could expand the risk areas for arboviruses such as chikungunya, which are transmitted by mosquitoes and ticks.
“The first licensed chikungunya vaccine will play an important role in preventing the suffering caused by this debilitating disease.” Dr. Richard Hatchett, said the CEO of the Coalition for Epidemic Preparedness Innovations in a press release. “Climate change is increasing the threat of chikungunya, which means safe and effective vaccines are needed now more than ever.”
Valneva said he expects the CDC’s Advisory Committee on Immunization Practices to vote on the vaccine recommendation in February 2024, and the company plans to begin commercializing it in the U.S. in early 2024. Ta.
References:
One Health Resource Center
