The actions of the French pharmacist Valneva fell more than 20% on Monday, after the United States Food and Medicines Administration (FDA) immediately suspended the license of its vaccine against Chikungunya, Ixchiq, citing serious security concerns.
The FDA Biological Evaluation and Research Center (CBER) indicated that the suspension was based on reports of more than 20 serious adverse events, including 21 hospitalizations and three deaths, with one of them directly related to encephalitis derived from the vaccine. The regulator pointed out that, although Ixchiq received accelerated approval in November 2023 for adults with the highest risk of Chikungunya, confirmation trials have not yet demonstrated a clear clinical benefit.
“CBER’s benefits and risks analysis shows that, in most plausible scenarios, the vaccine does not provide benefits that overcome the risks,” said the agency, adding that its continued use “would represent a danger to health.”
Valneva’s shares backed up 22.1%, on the way to their worst day since June 2022 and playing minimums within the French stock market index SBF120. The titles of the company that quote in the United States also fell more than 20% in the first operations.
Valneva announced that he would immediately suspend the shipping and sale of Ixchiq in the United States, and that he will evaluate the possible impact of permanently withdrawing the US market vaccine, although not modifying its financial prospects.
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IXCHIQ represented 7.5 million euros (8,78 million dollars), or more than 8% of Valneva’s total sales, in the first semester of 2025.
With the FDA suspension, Bavarian Nordic becomes the Vimkunya supplier, the only vaccine against Chikungunya available in the United States. Vimkunya was approved by the FDA in April for the protection of people over 12 years.
Despite considering the suspension as a setback, the Kempen Stock Exchange house pointed out in a note that considers Ixchiq only as a minor factor to invest in Valneva: “We see the negative reaction of the price of shares today as an attractive entry point,” they added.
Chikungunya can cause high fever, joint pain and long -term disability, and is mainly transmitted by mosquitoes of the Aedes genus, including the so -called “tiger mosquito”, which also transmits dengue.
Ixchiq, which was also approved in Europe, uses a weakened form of the virus to stimulate the immune response.
With Reuters information
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