The U.S. Food and Drug Administration (FDA) has removed its previous restriction on the use of Valneva’s chikungunya vaccine, Ixchiq, in adults aged 60 and older. This decision follows a completed benefit-risk assessment that included adults of all ages, for whom the vaccine has been approved since November 2023. Alongside the decision to lift the pause, the FDA has revised the vaccine’s labeling to include more stringent language regarding its use and associated risks.
The FDA and the Centers for Disease Control and Prevention (CDC) had jointly recommended suspending the use of Ixchiq in individuals aged 60 and above in May. This recommendation followed post-marketing reports of serious adverse events, including at least two deaths, in vaccine recipients aged between 62 and 89.
The initial U.S. restriction was aligned with a similar regulatory move in Europe. The current decision to resume administration in older adults comes after a similar recommendation was issued by the European Medicines Agency in July.
As part of the updated guidance, the FDA has introduced changes to Ixchiq’s label. The language describing the vaccine’s intended population has been modified. While the original label stated that Ixchiq was approved for individuals at “increased risk” of exposure to the chikungunya virus (CHIKV), the revised label now limits that population to those at “high risk” of exposure.
A newly added “limitations of use” section to the indications outlines that Ixchiq is “not advisable” for most U.S. residents traveling internationally, due to the generally low risk of exposure to the virus in such scenarios.
The updated label states, “The decision to administer Ixchiq should take into consideration an individual’s risk of severe or chronic disease outcomes if infected with CHIKV and risks of serious, severe, or prolonged chikungunya-like illness caused by vaccination with Ixchiq, in addition to the risk of exposure to CHIKV,” according to the FDA.
Additional updates to the prescribing information include warnings regarding the potential for serious adverse events, especially among individuals over 65 years of age who have one or more chronic medical conditions.
As of August 5, the CDC’s ArboNET surveillance system had recorded 46 travel-associated chikungunya cases in the United States.
The decision regarding Ixchiq comes at a time when the World Health Organization has noted a rise in chikungunya outbreaks in several regions. The CDC has issued travel alerts for outbreaks in Bolivia, Kenya, Madagascar, Mauritius, Mayotte, Réunion, Somalia, Sri Lanka, and China’s Guangdong province. The outbreak in Guangdong and nearby Hong Kong has become China’s largest documented chikungunya outbreak, with over 7,000 cases reported since June.
In its advisory, the CDC stated that two chikungunya vaccines are approved in the United States. Along with Ixchiq, which is a live-attenuated vaccine, Vimkunya, a virus-like particle vaccine developed by Bavarian Nordic, was approved in February 2025 for use in individuals aged 12 and older. Bavarian Nordic is currently undergoing a proposed acquisition by Nordic Capital and Permira. However, ATP, the company’s largest shareholder, has objected to the transaction.
Vimkunya is also being evaluated in a phase 3 trial involving children aged 2 to 11, with results expected in the first half of 2028.
Valneva has stated that the FDA is reviewing a possible extension of Ixchiq’s approval to include adolescents, as well as additional data regarding the vaccine’s durability. The European Commission granted Ixchiq marketing authorization in April for individuals aged 12 and above.
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