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Italy bans Novartis flu vaccines pending tests

Source: Thomson Reuters Foundation - Wed, 24 Oct 2012 17:14 GMT
Author: Reuters
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ROME/ZURICH, Oct 24 (Reuters) - Italy banned the sale and use of anti-influenza vaccines produced by Novartis on Wednesday pending tests for possible side effects, prompting authorities in Switzerland to also take precautionary steps.

The Italian Health Ministry advised citizens not to buy or use the drugs Agrippal, Fluad, subunit Influpozzi and adjunvated Influpozzi until further notice.

It said 487,738 vaccine doses were affected, and the move came after the Italian Pharmaceutical Agency decided further tests on the products may be necessary following indications of possible side effects.

Switzerland's drug watchdog then also raised a precautionary red flag for flu vaccines Agrippal and Fluad, saying that at most 160,000 doses were affected.

"Given the current unclear situation Swissmedic has issued a halt to deliveries for the cited vaccines and recommends not using them until further notice," it said.

Preliminary investigations had shown Italy's ban came after the discovery of white particles in the injections, which could suggest some of the components of the vaccine had clumped together, Swissmedic said.

Novartis said it was cooperating with Italian health authorities to understand the reasons behind the decision, and it had already provided authorities with an assessment in support of the quality, efficacy and safety of the vaccines.

Last week, Italy's Health Ministry said Netherlands-based vaccine maker Crucell, a unit of U.S. drugmaker Johnson & Johnson, had suspended a delivery of 2.36 million seasonal flu vaccine doses to Italy after finding problems with two lots of it.

The ministry said last week it would make up the shortfall by purchasing more doses from other manufacturers.

Italy uses between 10 million and 12 million doses of flu vaccines every year, according to the ministry.

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