US health authorities have suspended the licence for the Ixchiq vaccine against the chikungunya virus following reports of “serious adverse events”, the drug’s French maker said on Monday.
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Ixchiq is one of just two vaccines approved by the US Food and Drug Administration (FDA) for the mosquito-spread virus, which mainly occurs in tropical and subtropical regions but has recently been discovered in countries worldwide.
French company Valneva obtained US approval for the vaccine in 2023, but reports of side effects have prompted reviews, in particular over its use in older patients, including by the European Medicines Agency this year.
“The suspension of the licence is effective immediately,” Valneva said of the FDA order issued on Friday, citing four additional cases of serious side effects, three of which involved people aged 70 to 82.
“As we determine potential next steps, and as the clear threat of chikungunya continues to escalate globally, Valneva remains fully committed to maintaining access to our vaccine as a global health tool,” chief executive Thomas Lingelbach said in a statement.
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The company said it was evaluating the financial impact of the suspension, but was “not modifying its revenue guidance at this time”.
It said Ixchiq generated sales of 7.5 million euros (US$8.8 million) in the first half of this year.