The FDA suspended the license for vaccine manufacturer Valneva’s chikungunya vaccine following reports of serious adverse events.
The decision halts all shipping and sales of the vaccine in the U.S., effective immediately, according to an Aug. 25 news release from Valneva.
The suspension comes after four new cases of the mosquito-borne viral disease occurring outside of the U.S. were reported through the Vaccine Adverse Event Reporting System. The move follows the FDA’s earlier decision Aug. 6 to lift a temporary pause on the vaccines used in people over 60 after initial adverse events were observed in older adults with underlying health conditions.
The newly reported cases prompted the FDA to suspend the license altogether, the release said. While Valneva acknowledged the side effects align with what was seen in clinical trials, the company said it will comply with the FDA decision.
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