This article is from the source 'bbc' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.
You can find the current article at its original source at http://www.bbc.co.uk/news/world-europe-30240620
The article has changed 3 times. There is an RSS feed of changes available.
Version 1 | Version 2 |
---|---|
Italy suspends Fluad flu vaccine from Novartis after deaths | |
(about 1 hour later) | |
Italy has suspended the use of two batches of a flu vaccine made by Swiss firm Novartis after four people died shortly after receiving the drug. | |
Italy's pharmaceutical watchdog Aifa said the suspension of Fluad was a precautionary measure - and tests were being conducted to establish whether there was a link. | |
Those who died were two women and two men aged between 67 and 87. | |
Novartis said "no causal relationship to the vaccine has been established". | 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. | Fluad is a flu vaccine given to the elderly, which was approved in 1997. |
In a statement, Aifa said: "At this point, it is not clear if there is a causal relationship or a link to the vaccination. | |
"A full picture will be formed only after a full analysis of all aspects, including the general health of the patients, their ages and probable conditions they might have had." | |
Novartis 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. | 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". | It added: "Patient safety is our first priority and we take these reports very seriously". |
Fluad has been tested in clinical trials with more than 70,000 patients, 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. | It added that Fluad had been used since 1997, during which time more than 65 million doses have been successfully administered around the world. |