The Food and Drug Administration has suspended the license for Valneva’s chikungunya vaccine Ixchiq amid safety concerns, the French manufacturer said Monday.
Valneva said in a statement that the FDA’s decision Friday came after it had received four reports of serious adverse events of chikungunya-like illness in vaccine recipients outside the U.S. The agency had recommended a pause in May for the vaccine’s administration to people 60 and older; it lifted the pause Aug. 6 after requiring an updated label from the company.
Three of the reported cases occurred in people ranging in age from 70 to 82, one of whom was hospitalized. The fourth case was in a 55-year-old.
The FDA granted accelerated approval to Ixchiq in November 2023 for adults at increased risk of exposure to the mosquito-borne virus, outbreaks of which have become more widespread globally over the last 20 years.
