EMA Investigates Adverse Events for Flu Vaccine

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-02-2014 15:03


The European Medicines Agency (EMA) is working with the Italian Medicines Agency (AIFA) and other European Union (EU) medicines regulatory authorities to investigate the cause of serious adverse events, including deaths, in a small number of elderly patients who had received the Fluad flu vaccine. According to the EMA, there is so far no evidence to suggest a causal link between the vaccine and the reported adverse events. The suspension is a precautionary measure.

AIFA has suspended the use of two batches of the flu vaccine produced by Novartis. Testing of the batches is underway, as well as a detailed analysis of the case reports from Italy, which includes examining all available information on the affected patients’ age, health condition, and medication regime.

The issue will be discussed by EMA’s Pharmacovigilance Risk Assessment Committee, a scientific body that brings together Europe’s experts on the safety of medicines, at its meeting that began on December 1, 2014.

Fluad is authorized in a number of EU member states. For the current vaccination campaign, 4 million doses of Fluad have been distributed in Italy. In the EU, the vaccine has also been distributed for the 2014-2015 flu vaccination campaign in Austria, Germany, and Spain.

Source: EMA


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