Italy Probes 11 Deaths in Novartis Flu Vaccine Review

Novartis AG's Basel Headquarters
A logo sits on a glass door outside Novartis AG's headquarters in Basel, Switzerland. A review of the two suspended batches “has confirmed that they are in conformity with all production and quality standards,” the Basel, Switzerland-based company said in a statement. Photographer: Gianluca Colla/Bloomberg

Italy’s drug regulator said it’s investigating the deaths of an additional eight people who took Novartis AG’s Fluad influenza vaccine, bringing to 11 the number of fatalities under review.

The eight fatalities include those of people who took doses of two batches of the drug that have been suspended as a precaution, as well as other lots of the vaccine, the Italian Pharmaceutical Agency said in a statement late yesterday.

“At the moment it’s not possible to confirm that there is a direct link between taking the vaccine and the reported deaths,” the agency said. “More complete information is necessary and a thorough analysis of the cases must be conducted.”

Novartis said yesterday that “no causal relationship” has been found between the vaccine and the deaths. A review of the two suspended batches “has confirmed that they are in conformity with all production and quality standards,” the Basel, Switzerland-based company said in a statement.

Italy’s drug regulator, known as AIFA, yesterday suspended two batches of the vaccine after three people died within 48 hours of receiving the shot. At the same time, the agency stressed the importance of vaccines to prevent influenza.

Fluad, approved in 1997, has a “robust” safety history, Novartis said yesterday.

The two batches suspended are numbered 142701 and 143301. The agency said people with home packs of the vaccine should check the lot numbers and contact their doctors for alternative vaccination options if the numbers match.

Convulsions in children immunized with a flu shot from Melbourne-based CSL Ltd. in 2010 were caused by an excessive immune response to viral components in the vaccine, a study found. GlaxoSmithKline Plc’s Pandemrix swine-flu vaccine has been linked with an increased risk of of narcolepsy in the U.K., Finland and Sweden.

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