Italy is the latest country to lift a ban on the use of Novartis's influenza vaccines, after fresh assessments confirmed their safety.
Last month, several European countries, as well as Canada and Singapore, stopped using Agrippal and Fluad due to a suspected quality defect. The move was prompted by Novartis informing the Italian Medicines Agency (AIFA) about the aggregation of proteins in some batches.
At the time, the Swiss major noted that these particles can occur in the vaccine manufacturing process and it was confident that there is no impact on the safety or efficacy of the vaccine. Now, following additional information provided by the company and AIFA's independent assessment, the halt has been lifted.
Distribution had already resumed for Canada, Switzerland and Singapore, while within the European Union, Italy is the regulatory reference country for Agrippal and Fluad. Novartis says it will continue to work with other countries to lift remaining precautionary measures and resume supply as soon as possible.
The firm added that for the 2012-2013 flu season over one million doses had been administered "with no unexpected adverse events reported to date".