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Germany orders recall of some Novartis flu shots

207 days ago

By FRANK JORDANS
Associated Press

(AP:BERLIN) German authorities ordered a recall Thursday of some batches of Novartis flu vaccine as a precautionary measure, after the company reported the appearance of small particles in the manufacturing process.

The Paul Ehrlich Institute, which is part of the country's Ministry of Health, said there had been no reports of particle formation in Germany or of any serious side effects during the current flu season.

"However, in the interest of risk prevention and consumer safety it is necessary to cancel the approval for certain vaccines, since the formation of particles in the vaccine and therefore the risk of serious side effects cannot be ruled out," the institute's president Prof. Klaus Cichutek said in a statement.

The decision affects four batches of the influenza vaccine Begripal and one batch of Fluad.

Italy's health ministry banned the sale of four Novartis flu drugs on Wednesday. These included Fluad and Begripal _ sold as Aggripal in Italy _ as well as two others: Influpozzi Adiuvato and Influpozzi Subunita.

Switzerland's regulator Swissmedic also suspended deliveries of flu vaccines from Novartis as a preventive measure against possible contamination.

Britain's Medicines and Healthcare products Regulatory Agency said there was currently no evidence to pull the vaccines off the market, but that it was gathering further information on the Novartis products.

The Swiss pharmaceutical company said Thursday it was cooperating with the Ministry of Health in Italy, where the vaccines are produced, and was committed to providing vaccines to patients for the upcoming flu season.

"Novartis confirms that these particles can occur in the vaccine manufacturing process and is confident that there is no impact on the safety or efficacy of the vaccine," the Basel-based company said.

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