Regulatory Focus™ > News Articles > Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines

Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines

Posted 26 October 2012 | By

Two influenza vaccines manufactured by Novartis, a Swiss pharmaceutical company, have seen their marketing privileges temporarily revoked in at least three European countries this week as regulators expressed concerns regarding contamination and possible adverse side effects.

The vaccines-Agrippal and Flaud-were first banned by the Italian Health Ministry after the Italian Pharmaceutical Agency (AIFA) said it was aware of the, "Presence of a protein aggregation phenomenon observed in the manufacture of seasonal influenza vaccines."

Regulators said the phenomenon's effect on the safety and efficacy of the vaccines was as yet unknown, and consequently issued a prohibition on the vaccines' sale and use in Italy.

Regulators from the Spanish Agency for Medicines and Health Products (AEMPS) and Switzerland's Swissmedic followed suit the next day. Spanish regulators said they had not seen any rise in adverse event reports with Novartis' vaccines sold before the ban, but had decided to ban the sale of the vaccine out of an abundance of caution. Swissmedic mirrored AEMPS' statement, saying it had banned the import and use of the vaccines as a "precautionary measure," and was not aware of any anomalous adverse event reports.

Novartis, meanwhile, said in a statement that it was working with regulators to clarify potential questions and expressed its, "Confidence in the safety and efficacy of its seasonal influenza vaccines Agrippal and Fluad manufactured in Italy."

"Patient safety is of the highest priority to Novartis," it said.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.