Italy has suspended the use of two batches of a flu vaccine made by Swiss firm Novartis amid reports that three deaths may have been linked to the drug. Italy’s pharmaceutical watchdog AIFA said the suspension of Fluad was a precautionary measure. The victims were two elderly women and an elderly man, according to Italian media reports. Novartis said “no causal relationship to the vaccine has been established”. Fluad is a flu vaccine given to the elderly, which was approved in 1997.
The company said it had a “robust” safety history. A review of the two batches in question has “confirmed that they are in conformity with all production and quality standards,” the company said. It added: “Patient safety is our first priority and we take these reports very seriously”. Fluad has been tested in clinical trials with over 70,000 patients and over 65 million doses have been distributed to date, added Novartis, which said it was working closely with AIFA for further assessment. It added that Fluad had been used since 1997, during which time more than 65 million doses have been successfully administered around the world.