FDA rescinds advice to halt Valneva's Chikungunya vaccine (IXCHIQ), revises drug instructions

FDA rescinds advice to halt Valneva's Chikungunya vaccine (IXCHIQ), revises drug instructions

The Food and Drug Administration (FDA) has removed the recommended pause on the use of the live-attenuated Chikungunya vaccine IXCHIQ in individuals 60 years and older, following an updated benefit-risk assessment. The vaccine remains authorized for use in people aged 18 and older who are at high risk of exposure to the chikungunya virus.

Key updated guidelines and information for individuals 60+ include:

• The FDA has approved updated Prescribing Information and Patient Information, reflecting new safety data and risk communications.
• IXCHIQ may cause severe or prolonged chikungunya-like symptoms, since it contains a live weakened virus; serious adverse events (neurologic, cardiac) had been reported post-market, including hospitalizations and one death by encephalitis, which prompted the earlier pause.
• The vaccine is now indicated more narrowly for those at high risk of exposure rather than broadly for increased risk, and its use in older adults should consider individual risk factors such as risk of severe or chronic disease from infection, risk of serious vaccine reactions, and likelihood of exposure.
• Healthcare providers are advised to carefully weigh these risks and discuss vaccination decisions with patients, especially travelers to chikungunya-endemic areas or people at risk of severe outcomes due to infection.

In summary, the FDA's current position is to allow IXCHIQ use in people aged 60 and above with updated safety labeling and a focused indication on high-risk individuals, after intensive safety review and removal of the prior pause recommended in May 2025 due to serious adverse event concerns. Continuous safety monitoring remains a priority, and adverse events should be reported to VAERS.

The Warnings and Precaution section of the product label for IXCHIQ has been expanded to reflect the SAE profile observed, especially in people above 65 years of age and older with one or more chronic medical conditions. The European Medicines Agency had announced in July to lift temporary restrictions in elderly people after a thorough review of IXCHIQ by its safety committee, and the FDA's decision to remove the recommended pause follows this announcement.

However, the product label for IXCHIQ remains contraindicated in the United States for individuals 60 years of age and older, following reports of Serious Adverse Events. The FDA is also progressing with ongoing reviews regarding the inclusion of additional persistence data for IXCHIQ.

For most U.S. travelers, the risk of exposure to Chikungunya Virus is low. The World Health Organization has highlighted the Chikungunya Virus as a major public health problem, and IXCHIQ should be given when there is a significant risk of chikungunya infection and only after careful consideration of the benefits and risks. Individuals 60 years or older who may be considered for IXCHIQ vaccination should consult their healthcare provider to evaluate personal risk, exposure chances, and potential vaccine benefits and risks in light of the FDA’s updated guidance.

[1] FDA. (2025). FDA Briefing Document. Retrieved from https://www.fda.gov/media/157597/download [2] FDA. (2025). FDA Drug Safety Communication. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-removes-recommended-pause-use-chikungunya-vaccine-ixchiq-individuals-60 [3] CDC. (2025). Chikungunya Virus. Retrieved from https://www.cdc.gov/chikungunya/index.html [4] Valneva SE. (2025). Press Release. Retrieved from https://www.valneva.com/news-and-events/press-releases/2025/valneva-announces-fda-removes-recommended-pause-use-chikungunya-vaccine-ixchiq-individuals-60-years-age-and-older [5] CDC. (2025). Travelers' Health - Chikungunya. Retrieved from https://wwwnc.cdc.gov/travel/page/chikungunya-travelers

1. The FDA's updated guidelines for individuals aged 60 and above include a focus on the use of the Chikungunya vaccine IXCHIQ in those at high risk of exposure, initially due to medical-conditions and health-and-wellness factors that might increase the severity of the virus if contracted.
2. In light of the updated FDA guidance, healthcare providers are encouraged to assess the medical-conditions of patients 60 years and older who may be considered for IXCHIQ vaccination, ensuring they are well-informed about the benefits and risks associated with the vaccine, particularly regarding science and health-and-wellness aspects.

Read also: