Valneva's Chikungunya Vaccine Sales Suspended in the US

Valneva shares fell 22% after the FDA suspended the license for its chikungunya vaccine, Ixchiq, following four reports of serious adverse events. The vaccine, which was marketed for people 60 and older, is no longer available in the US. Valneva will continue to sell the vaccine in other countries where it remains licensed.

Valneva shares (VLA) plummeted by approximately 22% on Monday following the United States Food and Drug Administration's (FDA) suspension of the license for its chikungunya vaccine, Ixchiq. The suspension, which took effect immediately, is in response to four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness [2].

The FDA's decision to suspend the license requires Valneva to cease shipping and selling Ixchiq in the United States. The suspension follows the FDA's earlier recommendation to pause the use of Ixchiq in individuals aged 60 and older, based on reported SAEs among elderly individuals with multiple underlying health conditions [3]. The latest decision to suspend the vaccine is based on updated data from the Vaccine Adverse Event Reporting System (VAERS), which now includes four additional SAEs that occurred outside the United States [3].

Valneva has stated that it is evaluating the potential financial impact of a permanent withdrawal of the Ixchiq license in the United States but has not modified its revenue guidance at this time. Sales of Ixchiq accounted for €7.5 million in the first half of 2025, representing more than 8% of the company's total product sales [1].

Despite the setback, brokerage firm Kempen Daily views the suspension of Ixchiq as a minor reason to invest in Valneva. The brokerage noted that the negative share price reaction could be seen as an attractive entry point [1].

Chikungunya, a mosquito-borne viral disease, causes high fever, joint pain, and long-term disability. The World Health Organization has highlighted chikungunya as a major public health problem, with significant economic impacts, particularly in the Americas [3].

Valneva remains committed to maintaining access to its vaccine as a global health tool and will continue to engage proactively with health authorities in all territories where Ixchiq is licensed. The company is also focused on accelerating vaccine access in low- and middle-income chikungunya-endemic countries [3].

References:
[1] https://www.tradingview.com/news/reuters.com,2025:newsml_L8N3UH05X:0-valneva-shares-tumble-after-suspension-of-u-s-chikungunya-vaccine-licence/
[2] https://valneva.com/press-release/valneva-announces-fdas-decision-to-suspend-license-of-chikungunya-vaccine-ixchiq-in-the-u-s/
[3] https://finance.yahoo.com/news/valneva-announces-fda-decision-suspend-050000615.html