A number of European Union member states have halted the use, as a precautionary measure, of some anti-influenza vaccines manufactured by Swiss drug major Novartis’ (NOVN: VX) vaccines, because of a suspected quality defect in the firm’s products manufactured in Italy the European Medicines Agency confirmed on Friday.
The Italian Medicines Agency (AIFA) was first informed of the suspected quality defect by the manufacturer (Novartis Vaccines) located in Italy. The Italian authorities took prompt precautionary action and the AIFA alerted all other member states, the European Commission and the European Medicines Agency using the established mechanisms. These regulatory actions are precautionary, since so far there is no indication that this suspected quality defect has any impact on the safety or efficacy of the vaccines in question.
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