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Novartis vaccines prohibited in Italy

on Tue, 10/30/2012 - 11:15


The Italian Ministry for Health and the Italian Medicines Agency (AIFA) disposed the precautionary and immediate prohibition for citizens to buy the four anti-influenza vaccines produced by Novartis Vaccines and Diagnostics S.r.l., due to the unexpected finding of protein aggregates that could theoretically lead to an increase of adverse reaction to the injection.
As it is explained in the AIFA official measure, the quality and toxicological reports presented by Novartis about the four vaccines – Fluad, Agrippal, Influpozzi Adjuvant and Influpozzi Subunit – did not provide sufficient explanations on the protein aggregates, nor on their impact on the quality, stability and effectiveness of the vaccines.
A total amount of 487.738 doses will be returned, thus causing a temporary problem of vaccines supplying in Italy. The Italian Ministry of Health reported that only 138 of those vaccines has been administered but no adverse effects has been observed.