Italy Investigates Novartis Flu Vaccine After 13 Deaths are Reported

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 Agenxia Italina del Farmaco, or AIFA, took the step as a precautionary measure after the deaths were reported between Nov. 8 and 25, according to a statement on the agency web site.

Most of the deaths have been among people who are more than 80 years old, and eight deaths occurred within 24 hours after the vaccine was administered. The first results of an analysis being conducted by the government’s Institute of Health are due this week, and the regulator says there are suggestions that there are “variations in the quality of the vaccine.”

For its part, Novartis issued a statement over the weekend saying that “no causal relationship to the vaccine has been established to date.” The drug maker notes that the two suspended batches comprising 500,000 doses were distributed only in Italy and passed “all required safety and quality testing.” AIFA, however, says the number of lots involved is now six, representing more than 1.3 million doses.

Fluad is “often prescribed to patients who suffer from pre-existing, underlying medical conditions and have a weaker immune system. Serious medical events and deaths are, unfortunately, quite common in this patient population and, hence, a coincidental timely association with vaccination is not unusual,” the drug maker said. [UPDATE: A Novartis spokesman later wrote us to say that “preliminary results performed by the Italian Authorities have not detected any manufacturing defect.”] 

The Italian regulator, meanwhile, said it expects Novartis to provide a status report today on “all quality controls repeated on lots seized and a clinical evaluation of the possible cause-effect relationships.” In addition, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has been asked to review the product and its report is expected to be completed later this week.

We asked AIFA and Novartis about the findings of the status report and will update you accordingly.

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.

11-December-2014