2025-04-18T08:00:00.000Z

---

Saint Herblain, France, April 18, 2025 In a significant update for travelers and health care providers, Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialized vaccine company known for its innovative approaches to immunization, announced today that the U.S. Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices (ACIP) has revised its recommendations regarding the use of Valneva's chikungunya vaccine, IXCHIQ.

During a meeting held on April 16, ACIP confirmed its recommendation for the use of IXCHIQ for individuals aged 18 and older who are traveling to regions experiencing outbreaks of the chikungunya virus (CHIKV). Additionally, they indicated that IXCHIQ may be considered for those aged 18 and older planning to live or travel for more than six months in areas where the chikungunya virus is not currently causing an outbreak but poses an elevated risk to U.S. travelers.

However, the committee also made a notable recommendation regarding individuals aged 65 and older. Following a review of six reported cases of serious adverse events (SAEs) associated with IXCHIQ, including five hospitalizations among individuals aged 67 to 86, ACIP advised caution. These SAEs were reported through the Vaccine Adverse Event Reporting System (VAERS), which is designed to be an early warning system for detecting potential safety concerns, even though it does not establish direct causality between the vaccine and the reported events.

All hospitalized individuals had pre-existing health conditions, and although a causal link to IXCHIQ was not definitively established, ACIP emphasized the need for further investigation into these cases. They underscored that in certain high-risk scenarios, such as during outbreaks, vaccination with IXCHIQ might still be warranted for older adults, given the substantial risk of severe chikungunya disease and the potential for hospitalization in this age group.

To illustrate the urgent need for vaccination, earlier this month, Valneva supplied 40,000 doses of IXCHIQ to La Runion, a French overseas territory currently facing a chikungunya outbreak. The local health authority, the Agence Rgionale de Sant (ARS), is prioritizing vaccinations for older adults, especially those with underlying health conditions, in an effort to protect the community.

Valneva has recently confirmed an additional order of 50,000 doses from the ARS to continue its support in managing this outbreak effectively. Overall, Valneva has distributed approximately 80,000 doses of IXCHIQ across the United States, Canada, and Europe. Since January 2025, there have been no further reports of serious adverse events worldwide, and Valneva's ongoing safety monitoring has not uncovered any safety issues inconsistent with the product's label, as reviewed by the U.S. Food and Drug Administration (FDA).

Dr. Juan Carlos Jaramillo, Chief Medical Officer at Valneva, emphasized the company's commitment to safety, stating, Valneva is dedicated to the highest safety standards, and we maintain a positive safety profile for IXCHIQ. We respect the ACIP recommendations and recognize the significance of maintaining stringent safety surveillance protocols. We urge healthcare providers to evaluate the risks and benefits of vaccination based on each patient's medical history and travel plans.

The revised recommendations from ACIP will require final approval from the Director of the CDC and the U.S. Department of Health and Human Services before being formally adopted.

About Chikungunya

The chikungunya virus (CHIKV) is transmitted through the bites of infected Aedes mosquitoes and leads to a debilitating illness characterized by fever, intense joint and muscle pain, headaches, nausea, fatigue, and rashes. The joint pain associated with chikungunya can be particularly severe and may last for weeks or even years.

Since its resurgence in 2004, chikungunya has caused widespread outbreaks around the globe, with the virus now identified in over 110 countries across Asia, Africa, Europe, and the Americas. Between 2013 and 2023, there were more than 3.7 million reported cases in the Americas alone, leading to a significant economic and healthcare burden. As climate change continues to impact the distribution of mosquito vectors, the World Health Organization (WHO) has identified chikungunya as a major public health issue that requires ongoing attention.

About Valneva SE

Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines to address unmet medical needs for infectious diseases. With a targeted approach and deep expertise in various vaccine modalities, Valneva aims to provide first-, best-, or only-in-class vaccine solutions. The company has successfully brought several vaccines from research and development to market, including the worlds first chikungunya vaccine and other proprietary travel vaccines.

Valnevas growing commercial success is instrumental in funding its vaccine pipeline, which includes the only Lyme disease vaccine candidate currently in advanced clinical development, a partnership with Pfizer, as well as a promising Shigella vaccine candidate and other vaccines aimed at global health threats.

For more information, please visit