Official Investigation As 13 Die Following Flu Vaccine – Italy

Italy Investigates Novartis Flu Vaccine After 13 Deaths are Reported

Ed Silverman – Pharmalot – Wall Street Journal – 1st Dec 2014

Italy has suspended the use of two batches of the Fluad flu vaccine made by Novartis after 13 people died shortly after the treatment was administered.


The episode occurs shortly before Novartis is due to transfer its vaccines business to GlaxoSmithKline as part of an asset swap deal in which Glaxo will transfer most of its cancer portfolio to Novartis. A Glaxo spokeswoman declined to comment.

This is the not the first time that Novartis has run into difficulties with vaccines produced in Italy. Two years ago, the drug maker suffered what it called a “data-handling discrepancy,” which caused some vaccines to be temporarily and voluntarily held for several months. Novartis inspected its manufacturing practices and submitted reports to the EMA and AIFA before shipments resumed.”

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