Novartis Flu Vaccine Banned In Italy After Suspicious Deaths
November 28, 2014 12:20 PM EST
A flu vaccine made by Swiss pharmaceuticals giant Novartis has been suspended in Italy amid fears it may have caused three deaths.
The Italian Pharmaceutical Agency (AIFA) banned the use of two batches of the Fluad vaccine after three people who had received it died and a fourth was taken seriously ill, the press release added.
The victims were two women aged 87 and 79 and a 68-year old man, all of whom died between November 12 and 19 in southern Italy, according to Italian media reports.
The fourth person, in 90s, is in hospital in a serious condition.
"Novartis has been notified by AIFA of the precautionary suspension of two lots of Fluad in Italy following reports of the serious adverse effects events after vaccination. No causal relationship to the vaccine has been established," the Swiss company said in a statement.
A review of the two batches "have confirmed that they are in conformity with all production and quality standards," it said.
"We need to make sure that the number of people who get vaccinated does not drop. We have to have faith in vaccines," said AIFA head Sergio Pecorelli, in the press release, who added that "8,000 people die of seasonal flu" each year.
In defense, the company said Fluad had been used since 1997, during which time over 65 million doses have been successfully administered throughout the world, "which confirms the data gathered during clinical studies which involved over 70,000 patients."