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FDA Suspends Valneva Vaccine’s License Following New Reports of Adverse Events
Valneva must immediately cease U.S. shipments and sales of Ixchiq, a vaccine for chikungunya virus. The FDA recently lifted a pause on dosing of Ixchiq, but the agency’s new safety alert is based on an assessment that found the vaccine appears to be causing chikungunya-like illness in recipients.
FDA suspends license for chikungunya vaccine Ixchiq over serious safety concerns
The US Food and Drug Administration (FDA) announced late last week that it has suspended the license for French drugmaker Valneva's chikungunya vaccine, saying that continued administration of the vaccine to the public would pose a danger to health.
FDA Suspends Approval for Ixchiq Chikungunya Vaccine, Citing Safety
The FDA said in a statement that it had determined that one of the two approved vaccines, Ixchiq (Valneva SE), which contains a live, weakened version of the chikungunya virus, was responsible for 21 hospitalizations and three deaths.
MedPage Today on MSN20h
In Abrupt Reversal, FDA Yanks Ixchiq Vaccine Over Safety Concern
According to the vaccine's maker, Valneva, the FDA based its decision to suspend the shot on four new serious adverse events ...
Pharmaceutical Technology on MSN20h
FDA bans Ixchiq in the US, sending Valneva shares plummeting
In a U-turn from a decision two weeks ago, the FDA – citing new safety events – said the vaccine is a "danger to health".
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