The Italian AIFA and National institute of Health (ISS) have declared Novartis’ FLUAD as safe
Towards the end of November Italian officials prohibited the use of two batches of Novartis’ flu vaccine FLUAD after 13 deaths were reported to have taken place shortly after vaccination (8 within 24 hours). There were concerns from the AIFA that there may have been quality deficits within the two batches affected (143 301 and 142 701), however they and the ISS have deemed the vaccine safe after a series of negative results from preliminary tests.
In the AIFA’s initial statement they took the time to explain that the reported deaths (which has now increased from 13 to 18) accounted for a tiny amount of deaths within the 65+ age group across any given month. And it may well be a heightened awareness of the debate surrounding vaccine safety that has actually lead to increased reporting from doctors and patients, rather than an increase in incidents.
The AIFA are keen however to remind the public that 8,000 Italians die of flu each year and urges all those vulnerable to the flu to get vaccinated.
Novartis has since stated that there has been no unusual increase in reports of adverse events this year from more than 7 million doses of FLUAD that have distrubuted this year.
See the AIFA release here.