In Paris Valneva collapses, Fda suspends its vaccine in the US
The measure, justified by new cases of serious side effects, takes effect immediately. The Franco-Austrian laboratory is assessing the financial impact of a possible permanent withdrawal of the drug
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(Il Sole 24 Ore Radiocor) - Valneva collapsed on the Paris Stock Exchange. The French-Austrian laboratory's stock dropped more than 25%. Sales on the stock were triggered by the news that the US health authority, the Food and Drug Administration (Fda), suspended the approval of its chikungunya vaccine, after new cases of serious side effects.
"This suspension goes into effect immediately and results in the discontinuation of the shipment and sale of Ixchiq," the vaccine's trade name, "in the United States," Valneva said in a statement. The move comes just weeks after a temporary halt to the vaccine for the over-60s was lifted following a review ofserious adverse effects, found mainly among older people with various chronic conditions. "This sudden suspension of the licence is based on updated data from the US Vaers (Vaccine Adverse Event Reporting System) surveillance system, which includes four new cases of serious side effects reported outside the US," the company explains. The group states that it will continue to analyse these cases in detail and, if necessary, take any action in connection with the FDA decision. Valneva is also evaluating the financial impact that could result from a possible permanent withdrawal of the vaccine in the US, but is not changing its revenue forecasts for the time being.
