FDA approves world’s first chikungunya vaccine
Click Here to Manage Email Alerts
Key takeaways:
- The FDA approved a chikungunya vaccine for people aged 18 years or older at high risk for exposure to the virus.
- A CDC committee is expected to vote on recommending the vaccine in February.
The FDA approved the world’s first vaccine against chikungunya virus.
The vaccine, Valneva’s Ixchiq, was approved for people aged 18 years or older who are at an increased risk for exposure to chikungunya, which is spread by bites from infected Aedes mosquitoes, similar to dengue and Zika. Clinical studies conducted among adolescents aged 12 to 17 years are ongoing, according to the company.
Chikungunya was first identified in 1952 in Tanzania, and the first urban outbreaks were recorded in Thailand and India in the late 1960s and 1970s, according to WHO.
The virus was not detected in U.S. travelers until 2006 and local cases were not reported until 2014, when there were 12 locally acquired infections in Florida and Texas and more than 4,600 cases in U.S. territories, including Puerto Rico and the U.S. Virgin Islands.
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “[This] approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”
The FDA in August extended the review period for the vaccine by 3 months so that Valneva could finalize the design of a phase 4 post-market safety monitoring study that is required as part of the accelerated approval process.
The single-dose, live-attenuated vaccine was approved based on phase 3 trial data showing a 98.9% seroresponse rate 28 days after vaccination, and a 96.3% seroresponse rate sustained 6 months after vaccination.
Experts have for years warned that climate change may expand the areas at risk for arboviruses like chikungunya that are spread by mosquitos or ticks.
“The first-ever licensed chikungunya vaccine will play a crucial role in preventing the suffering caused by this debilitating disease,” Richard Hatchett, MD, CEO of the Coalition for Epidemic Preparedness Innovations, said in a press release. “Climate change is intensifying the threat posed by chikungunya, which means safe and effective vaccines are needed now more than ever before.”
Valneva said it anticipates the CDC’s Advisory Committee on Immunization Practices will vote on recommending the vaccine in February 2024, and the company plans to start commercializing it in the U.S. in early 2024.
References:
- CDC. Chikungunya virus: Transmission. https://www.cdc.gov/chikungunya/transmission/index.html. Last reviewed Nov. 30, 2022. Accessed Nov. 10, 2023.
- CDC. Chikungunya virus: Chikungunya in the U.S. https://www.cdc.gov/chikungunya/geo/chikungunya-in-the-us.html. Last reviewed Oct. 11, 2023. Accessed Nov. 10, 2023.
- FDA approves first vaccine to prevent disease caused by chikungunya virus. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-prevent-disease-caused-chikungunya-virus. Published Nov. 9, 2023. Accessed Nov. 10, 2023.
- Valneva announces U.S. FDA approval of world’s first chikungunya vaccine, Ixchiq. https://valneva.com/press-release/valneva-announces-u-s-fda-approval-of-worlds-first-chikungunya-vaccine-ixchiq/. Published Nov. 10, 2023. Accessed Nov. 10, 2023.
Perspective
Back to Top
The mosquito-transmitted disease chikungunya has been responsible for several large outbreaks in the last decade, including a massive one in the Western Hemisphere in 2013-2015 and a large outbreak in Paraguay in the last year.
The acute illness can be distinctly painful because of severe arthralgias and, in some patients, acute arthritis. Even more worrisome is the potential for persistent joint pains and chronic arthritis in some patients, which may persist for months to years.
The approval by the FDA of a live-attenuated chikungunya vaccine offers an exciting new option for the prevention and control of chikungunya in endemic areas and for travelers to regions of the world with ongoing outbreaks or endemic transmission of the virus.
Collapse
Read more about
Click Here to Manage Email Alerts