Regulatory Focus™ > News Articles > Three More Regulators Move to Ban Sale of Novartis Vaccine

Three More Regulators Move to Ban Sale of Novartis Vaccine

Posted 29 October 2012 | By

Three more regulatory agencies have called for the recall and cessation of sales of two influenza vaccines manufactured by Novartis after the company reported finding particulate matter during its manufacturing process.

The Italian Pharmaceutical Agency, AIFA, announced on 25 October it has banned the use and sale of Agrippal and Fluad, trivalent influenza vaccines, after it said it had become aware of the "presence of a protein aggregation phenomenon observed in the manufacture" of the vaccines. Because regulators were unable to obtain sufficient information to determine the composition of the substance or its potential impact on the safety and efficacy of the vaccines, it said it was issuing a quarantine provision until a full investigation was carried out.

Switzerland's Swissmedic and Spain's Agency for medicines and Health Products (AEMPS) followed AIFA's lead, banning the sale of the vaccines shortly thereafter. AEMPS said its preliminary investigation indicated the particles were native to the vaccines, and were not eternally contaminated. Neither agency issued a recall, though Swissmedic issued an import ban on the vaccines.

Additional regulatory agencies are issuing restrictions on the sale of the vaccine. Germany's Ministry of Health said it would recall certain batches of the vaccines in response to the "theoretical risk" that patients could be harmed by the particulate aggregation. France's ANSM said it had agreed to, "temporarily suspend the distribution and dispensing of the vaccine Agrippal.

Health Canada, meanwhile, said it Novartis was voluntarily cooperating with regulators to suspend distribution of both vaccines. Canadian regulators said they have seen similar clumping in the past "and has observed no impact on their safety or effectiveness."  Regulators said they were unaware of any adverse events occurring as the result of the vaccine, but were launching a thorough review of the situation.

In a statement, Novartis said it remained "confident in the safety and efficacy of its seasonal influenza vaccines Agrippal and Fluad manufactured in Italy," and had not received any report of unexpected adverse events.

"The company is proactively engaging with local health authorities to answer remaining open questions and is fully committed to providing high quality vaccines to patients," it explained.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.