There is no evidence that Novartis’s Fluad is unsafe, the European Medicines Agency (EMA) says, after 13 deaths in Italy were reported as being associated with the influenza vaccine.
The EMA’s pharmacovigilance risk assessment committee (PRAC) assessed the events and concluded that there was “no evidence for a causal relation between the reported fatal events and the administration of Fluad”.
The reports had led the Italian medicines regulator, Agenzia Italiana del Farmaco (AIFA), to suspend the use of two batches of the vaccine as a precautionary measure on 27 November 2014, but it recommended that the country’s annual vaccination programme should go ahead.
Fluad is not licensed for use in the UK, but is authorised for use in Austria, Belgium, Germany, Denmark, Greece, Spain, France, Ireland, Luxembourg, Portugal, and Sweden. It is used in people aged 65 years and over, particularly in those with concomitant illnesses and those at increased risk of health complications.
Sergio Pecorelli, AIFA’s president, called for people at risk to be vaccinated “in order to avoid the complications of influenza, which causes about 8,000 deaths each year in Italy, particularly in the over 65s”.
“The assessment of the PRAC is reassuring as member states across the EU continue with their annual flu vaccinations campaigns,” the EMA says.
