Wednesday, October 24, 2012

Reuters: Regulatory News: UPDATE 2-Italy bans Novartis flu vaccines pending tests

Reuters: Regulatory News
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UPDATE 2-Italy bans Novartis flu vaccines pending tests
Oct 24th 2012, 15:50

Wed Oct 24, 2012 11:50am EDT

ROME Oct 24 (Reuters) - The Italian health ministry said on Wednesday that it had imposed an immediate ban on the sale and use of four anti-influenza vaccines produced by Swiss drugs group Novartis pending tests for possible side effects.

The ministry said it 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.

The move comes after the Italian Pharmaceutical Agency decided that further tests on the products may be necessary following indications of possible side effects.

Novartis said it was cooperating with the Italian health authorities to understand the reasons behind the decision, adding that the temporary halt on sales only applied t o Italy.

It said it had already provided authorities with an assessment i n support of t he 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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