EMA Okays Use of Novartis Vaccine

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-09-2014 13:22


The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no evidence that Fluad, a flu vaccine manufactured by Novartis, has caused serious events including deaths in Italy. These reports led the Italian Medicines Agency to suspend the use of two batches of Fluad as a precautionary measure on November 27, 2014.

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. 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.

Fluad is authorized in the European Union (EU) in a number of member states. For the current vaccination campaign in Italy, about 4 million doses of Fluad have been distributed. The vaccine has also been used for the 2014/15 flu vaccination campaigns in Austria, Germany and Spain. Fluad is authorized in Austria, Belgium, Germany, Denmark, Greece, Spain, France, Ireland, Luxembourg, Portugal, and Sweden.

Source: European Medicines Agency


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