The Food and Drug Administration (FDA) has suspended the license for French drugmaker Valneva’s chikungunya vaccine, Ixchiq, effective immediately.
The FDA’s Center for Biologics Evaluation and Research (CBER) said the suspension was based on over 20 serious adverse events.
The serious adverse events included 21 hospitalizations and three deaths.
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According to Reuters, one fatality was directly linked to vaccine-derived encephalitis.
“This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of disease caused by the chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV,” the FDA stated.
“CBER’s decision is based on serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness
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