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Novartis Flu Vaccine Cleared by European Medicines Agency

by Dr. Trupti Shirole on December 5, 2014 at 9:49 AM
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 Novartis Flu Vaccine Cleared by European Medicines Agency

No evidence for a causal relation between the reported fatal events in Italy and the administration of Novartis flu vaccine Fluad has been found by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA).

During the current vaccination campaign in Italy, 19 people were reported to have died after being given the jab. The Italian Pharmaceutical Agency (AIFA) said, "It had been notified of 19 deaths among people who had died following vaccination with Fluad. But preliminary tests ruled out any contamination in two batches of the drug that were taken out of circulation the previous week."


Fluad has been in use since 1997 and 65 million doses have been given to people around the world. It is used in older people, over 65 years of age, especially in those who have several ailments at the same time and are at an increased risk of health complications.

EMA said that four million doses of the flu vaccine had been distributed for the current vaccination campaign in Italy, and the vaccine had also been used in Austria, Germany and Spain.

Source: Medindia

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