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France, Germany and Spain join list of countries banning Novartis vaccines

Flu vaccines Agrippal and Fluad withdrawn after some batches found to be contaminated

France, Germany and Spain have joined Switzerland, Austria and Italy in banning flu vaccines produced by Novartis after small particles were found in batches of both Agrippal and Fluad.

In France, Health Minister Marisol Touraine called for all doses of Agrippal to be withdrawn from the market, although she emphasised that there was no known risk for patients using the vaccine in France.

The nation's stance, which doesn't extend to Fluad, is pending action from the European Medicines Agency (EMA) regarding the matter, despite vaccines being the responsibility of member states.

The Agency can, however, be requested to support country-specific issues by individual governments.

France's decision mirrors that of Germany, which also said it would ban four batches of Agrippal – marketed in the country as Begripal. In addition, one batch of the Fluad vaccine will also be withdrawn.

Like France, Germany's Paul Ehrlich Institute, which is the vaccines division of the Ministry of Health, said that no adverse events had been reported in patients using the vaccine, but measures were still necessary.

Professor Klaus Cichutek, president of the Institute, said: “In the interests of risk management and the safety of consumers, it is necessary to withdraw approval for certain batches of vaccines, as particles have been found in the vaccines and the potential for serious side effects cannot be excluded."

Spain has also withdrawn Agrippal and Fluad, which is known as Chiromas in the country.

The Spanish Agency for Medicines and Health Products (AEMPS) said it was freezing all use of both vaccines as a precautionary measure, pending a complete report based on an investigation by Novartis.

These three countries join Switzerland, Austria and Italy, all of which had already implemented bans following the discovery of contaminate vaccines in Italy.

In a statement, Novartis confirmed the contamination, but said any risk was minimal and it was “confident that there is no impact on the safety or efficacy of the vaccine”.

The company is currently working with the Italian Ministry of Health and the Italian Medicines Agency to “understand the reasons for their decision and to clarify any questions”.

In the meantime, the company has set up a website to try and answer questions from member of the public with any worries about the vaccine.

29th October 2012

From: Regulatory, Healthcare

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