Federal authorities revoke vaccination authorization for chikungunya treatment due to escalating safety concerns
The Food and Drug Administration (FDA) has temporarily suspended the license for Valneva's chikungunya vaccine Ixchiq, following reports of serious adverse events in vaccine recipients outside the U.S.
The suspension, announced by Valneva on Monday, comes after the FDA received four reports of chikungunya-like illness in Ixchiq recipients. The reports involved individuals aged between 55 and 82 years old, with three cases occurring in individuals aged 70 to 82, one of whom was hospitalized.
The FDA's decision was made in May 2023, after granting accelerated approval to Ixchiq for adults at increased risk of exposure to the mosquito-borne virus in November 2023. The accelerated approval was for adults at increased risk of exposure to the chikungunya virus.
Initially, the FDA had recommended a pause in May for the vaccine's administration to people 60 and older. However, the pause was lifted on Aug. 6, after the FDA required an updated label from Valneva.
The chikungunya vaccine Ixchiq was developed to address the growing global concern over outbreaks of the chikungunya virus, which have become more widespread over the last 20 years. The accelerated approval of Ixchiq was aimed at adults at increased risk of exposure to the virus.
The European Medicines Agency (EMA) also temporarily suspended the license for Ixchiq in May 2023 due to safety concerns related to adverse events reported after vaccination.
The FDA's suspension of the license for Ixchiq is a significant development in the ongoing efforts to combat the chikungunya virus. The agency will continue to monitor the safety of the vaccine closely and will provide updates as more information becomes available.
