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October 28, 2012

Use of Novartis’s anti-influenza vaccines halted by EU member states

The use of an anti-influenza vaccines manufactured by Novartis Vaccines has been halted by some European Union (EU) member states because of a potential quality defect.

By Heidi Vella

The use of an anti-influenza vaccines manufactured by Novartis Vaccines has been halted by some European Union (EU) member states because of a potential quality defect.

Italy was the first country to become aware of the potential defect in vaccines Agrippal and Fluad when Novartis voluntarily informed the Italian Medicines Agency (AIFA), who then alerted other member states and the European Medicines Agency.

The suspected defect involves the aggregation of proteins that are a normal part of the vaccines.

The suspension on using the drugs is purely precautionary at this stage as there is no evidence the suspected quality defect affects the safety or efficacy of the vaccine.

AIFA is now investigating the suspected quality defect on behalf of the EU to determine whether the defect affects the safety and efficacy of the vaccines and whether the affected batches should be completely removed from the market.

The European Medicines Agency (EMA) is supporting AIFA but does not have an official role as the use of the vaccines is authorised nationally. The EMA will bring its expertise to assist AIFA and authorities in other member states.

Individual countries will manage the deficiency of the vaccine, which is manufactured in Italy, from their seasonal influenza vaccination programme, which is a vital part in their individual public health service.

Last week Swiss drug maker Novartis confirmed its confidence in the safety and efficacy of the drugs and said it would assist the AIFA in its investigation.

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