Watchdog clears Novartis in flu jab scare
AFP · 4 Dec 2014, 08:32
Published: 04 Dec 2014 08:32 GMT+01:00
- Italy examines 13 deaths in Novartis flu jab probe (01 Dec 14)
- Italy suspends Novartis vaccine after three die (27 Nov 14)
- EU clears Novartis sale of animal health unit (03 Oct 14)
The European Medicines Agency (EMA) said on Wednesday that its Pharmacovigilance Risk Assessment Committee (PRAC) concluded "there is no evidence that Fluad . . . has caused serious events including deaths" in Italy.
EMA said that four million doses of Fluad, produced by Basel-based Novartis, had been distributed for the current vaccination campaign in Italy, and the vaccine had also been used in Austria, Germany and Spain.
"Fluad is used in older people (65 years of age and older), especially in those who have a number of illnesses at the same time and are at an increased risk of health complications," the statement noted.
"After the review of the cases reported, the PRAC concluded that there was no evidence for a causal relation between the reported fatal events and the administration of Fluad."
On Monday, the Italian Pharmaceutical Agency (AIFA) said it had been notified of 19 deaths among people who had died following vaccination with Fluad.
But it said preliminary tests ruled out any contamination in two batches of the drug that were taken out of circulation the previous week.
Novartis says there is no evidence to link the deaths to the vaccine, which has been in use since 1997 and of which 65 million doses have been given to people around the world.
EMA, citing World Health Organization (WHO) figures, said flu caused about three to five million cases of severe illness worldwide each year, resulting in between 250,000 and 500,000 deaths.
"Influenza vaccines are the most effective way to prevent the disease and the serious complications it can cause," the London-based agency said.