Preliminary investigations by the Italian drugs safety agency have found no manufacturing defect in the influenza vaccine Fluad, which has been linked to the deaths of 13 older people in Italy.
Two batches of the product – which is not licensed for use in the UK — have been removed from the medicines supply chain after reports of serious adverse events.
Some 4 million doses of Fluad have been made available in Italy and the product is recommended in Austria, Germany and Spain for use in their 2014–2015 annual flu vaccination programmes.
The Italian medicines regulator Agenxia Italiana del Farmaco (AIFA) said in a statement on 1 December 2014 that initial safety tests on the withdrawn batches were “completely negative” and recommended that the annual vaccination programme should continue.
In an earlier statement, issued on 28 November 2014, it said: “AIFA decided to adopt a ban on the use of the two lots of the vaccine Fluad, waiting to check — in the light of the results of laboratory analysis, additional clinical reports and autopsy reports — any correlation between administration of doses and adverse events reported.”
The European Medicines Agency (EMA) is working with AIFA and other regulators to investigate the cause of the serious adverse events. The EMA said on 28 November 2014 that so far there was no evidence to suggest a “causal link” between the vaccine and the reported adverse events.
The EMA’s Pharmacovigilance Risk Assessment Committee is due to discuss the issue when it meets on 1–4 December 2014. The EMA will release an updated statement after the meeting, the agency confirmed.