Key Points :
FDA revokes U.S. approval of Valneva's chikungunya vaccine, Ixchiq, based on four severe adverse events.
Valneva will need to halt all shipping and sales of the vaccine in the country effective immediately.
Key Background :
French-Austrian biotech company Valneva titled the vaccine Ixchiq the world's first approved chikungunya vaccine. Subsequently licensed in the United States in 2023 and subsequently in the European Union, the vaccine was a milestone moment in the fight against a neglected tropical disease.
Chikungunya is transmitted by Aedes and results in immobilizing fever and arthralgia. The disease had surfaced in epidemic fashion in Africa, Asia, and the Americas and had spread to new nations due to climate change and air transport. The lack of measures for prevention made Ixchiq's approval even more giant-sized as a public health triumph, especially among travelers and in the endemic population.
But monitoring following marketing subsequently caused alarm. In May 2025, US regulators issued a warning against its use in persons aged 60 years and older after receiving reports of severe neurologic and cardiac adverse events, including hospitalization and death. This was soon followed by the European regulators, who had previously warned against the risk-benefit profile of the vaccine in elderly adults.
By July 2025, the European Medicines Agency eased its hold after reconsideration and declared that the vaccine was still indicated in susceptible patients. The U.S. FDA also updated the product label, restricting its use and discouraging repeat vaccination in most travelers, especially elderly patients with comorbidities.
Still, four hazardous side effects took place in August of 2025, and the FDA responded by increasing its action. Safety overrode benefits and led the agency to ask for total revocation of Ixchiq's license. That is to say, at least for now, the vaccine is not allowed to sell or distribute in the United States.
The suspension places Valneva in the same regulatory and reputational dilemma. It also questions more broadly the future of live-attenuated vaccines against new emerging disease threats when rapid approvals will presumably be followed by unexpected safety concerns the moment the products are applied to more patients. For the world's health regulators, the action underlines the delicate balancing act between speed and accountability to ensure the safety of patients.
About the Author
Kevin Smith
Kevin Smith is a Managing Editor at World Care Magazine.