Italy bans Novartis vaccines even after company assures their safety

Johnson & Johnson withholds its flu vaccine for tests on quality
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Italy is having a difficult time getting flu vaccine. Italian authorities today said they are banning four different Novartis ($NVS) vaccines because of questions over "side effects" less than two weeks after being told by Johnson & Johnson ($JNJ) vaccine unit Crucell that its flu vaccine was being withheld over quality concerns.

The Italian Medicines Agency said it is "banning" the sale of Novartis' Aggripal, Fluad and Influpozzi, based on information it received from the company that the vaccines "can produce collateral effects," according to a report from AFP news. The agency said it would carry out further tests to determine the "quality and safety" of the nearly half a million doses of vaccine. It is recommending citizens not use Agrippal, Fluad, subunit Influpozzi and adjunvated Influpozzi until further notice.

In a statement emailed to FiercePharma by Novartis spokeswoman Julie Masow, the company said, it "has taken note of the Italian Health Minister's decision" but that "Novartis has already provided the Authorities with an assessment which supports the quality, the efficacy and the safety of the vaccines." She emphasized the decision was Italy's alone and that the "company is fully committed to providing high quality vaccines to patients."

The company's vaccine unit has been struggling of late, having reported a $249 million operating loss last year on $2 billion in revenue. Revenue peaked in 2010 at $2.9 billion.

Novartis is not the only supplier creating flu vaccine supply issues for Italy, and elsewhere. Just two weeks ago, authorities there announced Italy would not receive 2.36 million doses of flu vaccine from Netherlands vaccine maker Crucell after that company withheld all of its vaccine, Reuters reports. Crucell's decision to "voluntarily" hold the drugs has also affected at least the U.K. as well, according to the BBC.

In a statement emailed to FiercePharma, the unit of Johnson & Johnson said, "Crucell is voluntarily holding all deliveries of our seasonal flu vaccines (Inflexal® V, Isiflu® V and Viroflu®) while we complete an internal investigation pertaining to two lots."

The company said it is awaiting "final results on the quality of these two lots before releasing any of the vaccines in the 2012/2013 flu campaign" and recommending customers seek other sources, something Italy has said it is doing. 

- read the AFP story 
- here's the Reuters story 
more from Reuters 
- still more from the BBC 

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