U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ

U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine IXCHIQ

• Recommendation for use in travelers and laboratory workers follows U.S. Food and Drug Administration (FDA) approval in November 2023¹
• IXCHIQ is the first and only vaccine approved to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the chikungunya virus

Saint-Herblain (France), February 29, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend use of Valneva’s single-dose chikungunya vaccine IXCHIQ for the prevention of disease caused by the chikungunya virus (CHIKV).

ACIP recommends IXCHIQ for persons aged ≥18 years traveling to a country or territory where there is a chikungunya outbreak. Additionally, it may be considered for persons traveling to a country or territory without an outbreak but with evidence of CHIKV transmission within the last five years, who are aged >65 years and likely to have at least moderate exposure to mosquitos (at least two weeks, cumulatively) or who are traveling for a longer duration (six months or more, cumulatively). ACIP also recommended chikungunya vaccination for laboratory workers with potential for exposure to CHIKV.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya poses a significant risk to individuals journeying to or residing in regions where the chikungunya virus and its mosquito vectors thrive. IXCHIQ offers advantages to travelers on vacation and visiting family and to people engaged in business ventures, missions, or laboratory duties. We embrace the ACIP endorsement, marking IXCHIQ as the only approved and recommended vaccine for the target population. We will continue collaborating with regulatory authorities worldwide to increase the accessibility of IXCHIQ across regions.”

The ACIP recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR) to advise healthcare providers on appropriate use of the vaccine.

About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite². While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032³. 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, and the virus has spread to more than 110 countries⁴. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas⁵ and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Before IXCHIQ, there were no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.