The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there was no evidence that Novartis-manufactured flu vaccine, Fluad, caused serious events including deaths in Italy.
Reassuring Member States over safety of flu vaccine, the review conducted by the committee found that the vaccine was safe for administration in vaccination campaigns.
The review follows after reports about fatal events led the Italian Medicines Agency (AIFA) to suspend the use of two batches of Fluad as a precautionary measure on 27 November 2014.
Authorised for use in the European Union (EU) in a number of Member States, Fluad is used in older people 65 years of age and beyond, especially in those who have a number of illnesses at the same time and are at an increased risk of health complications.
As part of the current vaccination campaign in Italy, about four million doses of Fluad have been distributed, while the vaccine has also been used for the 2014/15 flu vaccination campaigns in Austria, Germany and Spain.
According to the World Health Organization (WHO) estimates, annual influenza epidemics result in about three to five million cases of severe illness worldwide and 250,000 to 500,000 deaths.
Fluad is authorised in Austria, Belgium, Germany, Denmark, Greece, Spain, France, Ireland, Luxembourg, Portugal, and Sweden.