FDA Approves First and Only Vaccine for Chikungunya Virus Prevention

The FDA has granted accelerated approval to Valneva’s Ixchiq, a single-dose, live-attenuated vaccine to prevent disease caused by chikungunya virus (CHIKV) in individuals aged 18 years and older with an increased risk of exposure to the virus.

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The FDA action makes Ixchiq the first and only licensed CHIKV vaccine approved in the United States for this significant medical need.¹ The global market for CHIKV vaccines is estimated to exceed $500 million annually by 2032.²

“Today, it is estimated that more than 75% of the world's population lives in areas at risk of CHIKV transmission due to factors such as global warming and climate change. Chikungunya has already spread to over 110 countries and is currently regarded as one of the most likely viral infections to emerge in new geographic areas,” said Valneva Chief Medical Officer, Juan Carlos Jaramillo MD, in a press release.¹ “Morbidity is high with 43% of CHIKV patients suffering from chronic chikungunya where joint pain, fatigue, and potentially debilitating effects may last from months to years and can have substantial impact on daily activities. As we are introducing Ixchiq, our objective is to make this vaccine available to the largest number of people that will benefit from it.”

In a pivotal Phase 3 trial, data released in March 2022 for Ixchiq showed a 98.9% seroresponse rate at 28 days following a single immunization. The seroresponse produced by the vaccine continued long-term, with a 96.3% seroresponse rate at six months following vaccination.¹ Valneva said it will continue to study the antibody persistence produced by the vaccine for at least five years.

CHIKV is transmitted by mosquitoes, and when an uninfected mosquito feeds on a person with CHIKV, the mosquito may become infected with the virus, which replicates over several days before it becomes transmissible when the mosquito bites a new human host.² More than 60 million US residents annually travel to countries in which mosquito-borne diseases are endemic.

Symptoms of CHIKV include fever, severe joint pain, joint swelling, muscle pain, headache, nausea, fatigue, and rash. Severe symptoms and mortality from the virus are rare in occurrence and are typically associated with other comorbidities. The Pan American Health Organization issued an epidemiological alert earlier this year after CHIKV incidence rates and mortality grew in the Americas, which the report said may become worse as a result of climate change.

“The first-ever licensed chikungunya vaccine will play a crucial role in preventing the suffering caused by this debilitating disease. Climate change is intensifying the threat posed by chikungunya, which means safe and effective vaccines are needed now more than ever before,” said Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), Dr. Richard Hatchett, in a press release.¹ “Through our partnership with Valneva and Instituto Butantan, CEPI—with support from the EU—will help to make this vaccine accessible to the people most affected by the virus in low- and middle-income countries.”

Although most patients who become infected will fully recover from the virus, some cases of eye, heart, and neurological issues have been reported with CHIKV. Both the very young and very old have an elevated risk for severe disease, as newborns infected during delivery and older individuals with underlying medical conditions may develop severe illness, which increases the risk of death.³

Valneva said it will begin commercializing Ixchiq in the United States in early 2024 as it works toward a vote from the Advisory Committee on Immunization Practices at the end of February 2024.

Because the indication was granted accelerated approval by the FDA based on anti-CHIKV neutralizing antibody titers, continued approval will be contingent upon verification of clinical benefit in confirmatory studies.

References

1. Valneva Announces U.S. FDA Approval of World’s First Chikungunya Vaccine, IXCHIQ®. Valneva. News release. November 10, 2023. https://valneva.com/press-release/valneva-announces-u-s-fda-approval-of-worlds-first-chikungunya-vaccine-ixchiq/

2. VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020. Accessed November 10, 2023.

3. World Health Organization. Chikungunya. Webpage. Updated December 8, 2022, Accessed November 10, 2023. https://www.who.int/news-room/fact-sheets/detail/chikungunya