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The FDA suspended Valneva’s U.S. license for its chikungunya vaccine Ixchiq due to serious safety concerns, multiple hospitalizations, and deaths linked to chikungunya-like illness.
Ixchiq’s suspension follows FDA’s earlier decision of removing its recommended pause on the use of Ixchiq after multiple reports of chikungunya-like SAEs.
Valneva announced today that FDA suspended the license for Ixchiq in the U.S., citing four reports of serious adverse events (SAEs) related to chikungunya-like illness. Ixchiq’s suspension is effective immediately, requiring Valneva to cease shipping and selling of Ixchiq across the U.S.
Ixchiq initially received approval from the FDA under the accelerated approval pathway in November of 2023 for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years and older who are at increased risk of exposure to CHIKV. CBER’s cited serious safety concerns related to the vaccine, which the agency says appears to be causing chikungunya-like illnesses in vaccine recipients.2
On May 9 of this year, FDA issued a safety communication informing the public about FDA and CDC’s recommended pause of the use of Ixchiq in patients 60 years-or-older. Following the recommended pause, FDA conducted an updated benefit-risk assessment for the use of the vaccine in patients 60 years-or-older, along with patients aged 18-and-older.
CBER’s benefit-risk analysis yielded data reflecting how the vaccine doesn’t provide benefits outweighing risks, under most plausible scenarios. For these reasons, CBER believes the vaccine is unsafe, and that continuing administration to the public poses a danger to health.2
On August 6, FDA removed its recommended pause on the use of Ixchiq in patients aged 60-and-older, citing an investigation of multiple SAEs predominantly occurring in older patients suffering from multiple underlying health conditions. One death due to encephalitis was attributed to the vaccine, along with an additional 20 reported SAEs all consistent with chikungunya-like illness, resulting in 21 hospitalizations and three deaths.
Thomas Lingelbach, Valneva’s chief executive officer, touched on FDA’s decision to suspend Ixchiq, saying, “As we determine potential next steps, and as the clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine as a global health tool for addressing and preventing outbreaks of this devastating illness. We aim to continue providing Ixchiq to all countries where the product is licensed and continue our efforts with our partners to accelerate vaccine access in low-and-middle-income chikungunya-endemic countries especially in response to any current or future chikungunya outbreaks, ensuring the vaccine reaches those most in need.”1
Valneva is undergoing an evaluation of the potential financial impact of Ixchiq’s permanent withdrawal of licensing in the U.S. However, Valneva plans to refrain from modifying its revenue guidance. Reported sales of Ixchiq in the first half of 2025 contributed $10.2 million of Valneva’s $123 million in total sales.
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