Agrippal regulatory update

Novartis said the Italian Medicines Agency (AIFA) lifted its temporary halt on the use of the pharma's seasonal influenza vaccines Agrippal and Fluad following an independent assessment by AIFA of additional information the company provided. Novartis said distribution has already resumed in Canada, Switzerland and Singapore, and that it will continue to work with other countries to lift remaining precautionary measures.

Last month, EMA said a number of EU member states halted the use of Agrippal and Fluad because of a suspected quality defect. EMA said it was a precautionary measure and there was no indication of a safety or efficacy defect. Novartis informed the AIFA about the suspected defect, which involved the aggregation of proteins, from the pharma's Italian manufacturing facility, and the AIFA alerted all other member states, the European Commission and the EMA. Novartis said internal assessments and the clinical data gathered during the 2012-13 seasonal influenza studies required for European licensure demonstrate a safety and immunogenicity profile similar to that of prior years. The pharma said data from the ongoing seasonal vaccination campaign revealed no safety signals. Agrippal and Fluad are not available in the U.S. Agrippal is a subunit influenza vaccine, while Fluad is a MF59- adjuvanted influenza vaccine. ...