Novartis flu vaccine suspended in Italy after deaths

The Telegraph
by Denise Roland

Two batches of a flu vaccine manufactured by Swiss drug giant Novartis have been suspended in Italy following the death of three people shortly after they had received the jab.

Two women aged 87 and 79 and a 68-year-old man from southern Italy died following jabs of the Fluad vaccine earlier this month. Another man, 92, is seriously ill in hospital.

Italian health officials stressed that the suspension was a precautionary measure and urged calm, while Novartis said there was no evidence the vaccine shot had caused the deaths.

The Italian Medicines Agency (AIFA) insisted vaccines were "a precious resource and irreplaceable for the prevention of seasonal flu".

Sergio Pecorelli, the head of AIFA, added that 8,000 people die of seasonal flu each year. "We have to have faith in vaccines," he said.

A Novartis spokesman that a review of the two batches in question had shown they conformed to "all production and quality standards" and that the drug maker was working closely with Italian health officials to carry out further tests.

The Fluad vaccine was approved in 1997 and more than 65m doses have been distributed to date. The vaccine has a "robust safety history", the spokesman added.

Fluad is not used in the UK's flu vaccination programme, nor licensed for use in Britain, a spokesman for Public Health England said.

"There are no implications for the safety of flu vaccines licensed and used in the UK, and we advise people to have the annual influenza vaccine as recommended," he added.

Novartis is in the process of selling its flu vaccine division to Australian drugmaker CSL. The deal, which valued the business at $275m (£176m), is expected to close in the second half of 2015. The Swiss drugmaker is also offloading the remainder of its vaccines business to Britain’s GlaxoSmithKline, as part of a three-way deal agreed earlier this year.