Italy: suspension of 2 batches of Fluad, Austria not affected
Austria has been informed by the Italian Medicines Agency (AIFA) of a precautionary suspension of two batches (142701 and 143301) of the influenza vaccine Fluad. The reason for the suspension is the occurrence of serious adverse events that have been reported in a temporal relationship with the vaccination. Currently, there is no confirmed causal relationship between the vaccinations and these serious events. Preliminary investigations have also shown that both batches meet production and quality standards. Further investigations will be conducted. Therefore, the recall should be considered a precautionary measure.
The influenza (flu) vaccine Fluad is also licensed in Austria. It is used for active immunization against influenza in elderly persons (65 years or older). However, the two batches blocked in Italy are only on the market in Italy. Austria is not affected because no vaccines with the affected batches have been shipped. There are currently no indications of adverse events in Austria. Neither serious nor mild adverse events have been observed throughout this year, and no such indications have been reported in recent years. The Austrian Medicines Agency is in close contact with the Italian authorities and will continue to monitor the situation closely.
The vaccine was licensed in 1997 and tested in clinical trials in tens of thousands of patients; since then, more than 65 million doses have been distributed worldwide.
Queries (technical): Dr. Christoph Baumgärtel, Tel: 050555/36004 E-mail: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
