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Italy investigates Novartis vaccine after death toll reaches 13

Firms insist on the Fluad's safety, with 65 million doses given in the last 17 years

Novartis building 

Italy's regulatory agency has uncovered several additional deaths among patients vaccinated with Novartis' flu shot Fluad after three more fatalities prompted the agency to suspend the product last week.

In a statement, the AIFA said it now has reports of 13 deaths among patients vaccinated with Fluad between November 15 and 28, with the latest involving an 83-year-old man who had multiple health issues and was on a number of different medications.

On Friday, the license for two batches of Fluad were suspended in Italy after reports of four deaths in people who had received the vaccine, although the regulator stressed it was a precautionary measure while an investigation tried to establish whether there was a link to the product. Now, six batches are under scrutiny.

The European Medicines Agency (EMA) has also started a review of the situation, with its Pharmacovigilance Risk Assessment Committee (PRAC) due to complete its examination on Thursday (December 4), according to AIFA.

Fluad has been on the market since 1997 and Novartis insisted that it has a "robust safety history" with some 65 million doses delivered over the last 17 years. The product has also been given to around 70,000 people in the context of clinical trials, said the company.

There is no evidence to suggest that there is a manufacturing issue, which would be the most likely cause of an unexpected toxicity in a product that has such extensive use in the market. Preliminary testing had confirmed that the two suspect batches "are in conformity with all production and quality standards," said Novartis.

Nevertheless, the Swiss company said it was taking the reports very seriously and was collaborating with AIFA during the investigation. "Patient safety is our first priority," it said in a statement.

Fluad was temporarily suspended from sale in Canada and Switzerland in 2012 after some batches of the product were found to exhibit protein 'clumping' but were subsequently deemed safe for use.

Nine of the 13 Italian deaths have been in people aged over 80, according to AIFA, which reported that there was a roughly equal split between male and female patients. Eight deaths occurred within 24 hours of the vaccine being dosed, with all seen within 13 days, and there were eight deaths attributed to cardiovascular causes.

The regulatory agency noted that 3.5 million doses of Fluad are being distributed in Italy at the moment and stressed the importance of vaccination in the elderly, saying that up to 8,000 deaths a year in older people are partly related to insufficient flu vaccine uptake.

Novartis' vaccines business is due to be transferred to GlaxoSmithKline (GSK) in an asset swap deal that will see the Swiss firm take over the latter's cancer portfolio, although flu vaccines are not included in that transaction and Novartis has said it intends to divest that business separately.

Article by
Phil Taylor

1st December 2014

From: Regulatory

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