Travelers to Cuba, Hong Kong, and 100 Countries Face Fewer Chikungunya Vaccine Options in 2026

Since late 2013, the chikungunya virus has been detected in the Americas Region, spreading to most countries, including the United States. Over the next ten years, more than 3.7 million mosquito-transmitted cases were reported in the Americas.

Based on today's announcement, travelers to chikungunya-endemic areas have one fewer vaccination option.

Valneva SE today announced the voluntary withdrawal of its Biologics License Application (BLA) and Investigational New Drug (IND) application for IXCHIQ®, its chikungunya vaccine, in the United States.

This decision follows the U.S. Food and Drug Administration's (FDA) suspension of the vaccine's biologics license in August 2025 due to reports of serious adverse events (SAEs), primarily among older adults.

Valneva was informed that the FDA placed the IND on clinical hold pending an investigation into a newly reported foreign SAE.

This event occurred outside of the U.S. and involved a younger adult who received three vaccines simultaneously, including IXCHIQ.

On January 19, 2026, Valneva stated that there are no active clinical studies involving IXCHIQ that are currently vaccinating participants. The company plans to proceed with its Phase 4 post-marketing clinical activities, pending further discussions with relevant regulatory authorities.

Furthermore, Valneva remains committed to the highest safety standards and continues to engage proactively with health authorities in all territories where IXCHIQ is licensed, including Europe, Canada, the United Kingdom, and Brazil.

The company believes that IXCHIQ, a live-attenuated, single-dose vaccine, has a favorable benefit-risk profile for people living in endemic and outbreak settings, where it may serve as a highly durable single-shot vaccine.

For U.S.-based international travelers planning trips in 2026 to over 100 countries with chikungunya transmission risk—such as Cuba, Hong Kong, Brazil, India, Indonesia, and the Philippines—the withdrawal means there is no domestic access to IXCHIQ.

Travelers may need to consider vaccination options abroad in licensed markets or rely on VIMKUNYA™ (a virus-like particle vaccine approved in the U.S. for those aged 12+).

Currently, the U.S. CDC recommends considering chikungunya vaccination for travelers at higher risk of exposure or severe disease, particularly given available alternatives such as VIMKUNYA.

Pre-travel consultations at local clinics are advised by the CDC's Travel Health Notices to assess health risk and vaccination options.