(Reuters) – Valneva announced on Monday that the American health authority, the Food and Drug Administration (FDA), had suspended the license of its vaccine against chikungunya Ixchiq in the United States, causing a fall in its scholarship course.
The measure, which comes after new cases of serious side effects noted by the FDA, is effective immediately and has the consequence of blocking the sale and shipping of the product to the United States.
On the Paris Stock Exchange, the title Valneva fell 23.85% around 8:50 am GMT and was about to accuse its worst session since June 2022. The SBF 120 lost 0.54% at the same time.
The suspension of the IXCHIQ vaccine in the United States comes a few weeks after the lifting of a temporary stop for those over 60 following a serious adverse effects, mainly in the elderly suffering from multiple chronic diseases.
“This sudden license suspension is based on updated data from the American surveillance system VAERS (opposing Vaccine Event Reporting System) including four new serious undesirable effects reported outside the United States,” Valneva said in a statement.
The group says it continues to analyze these cases in detail and, if necessary, carry out any procedures relating to the decision of the FDA.
He adds currently assessing the financial impact that could have a final withdrawal from the License of Ixchiq in the United States but does not currently modify its turnover forecasts.
In the first half, Ixchiq generated 7.5 million euros, or more than 8 % of the total turnover of Valneva.
The vaccine, also approved in Europe, is the first developed as a preventive against chikungunya. It uses a weakened form of the virus to stimulate the immune response.
Despite the reverse in the United States, the Kempen broker considers the fall of the title as an opportunity to purchase, stressing that Ixchiq represents a minor part of the investment argument for Valneva.
According to the broker, the main engine remains the candidate vaccine against Lyme disease, currently in phase 3, whose results are expected by the end of 2025.
(Written by Noemie Naudin, edited by Blandine Hénault)
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