Germany, France join crowd withdrawing Novartis vaccines

Authorities find no particulates but pull flu vaccines as precaution
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Much of the EU crowd has decided to jump on the bandwagon, pulling some of Novartis' ($NVS) flu vaccines from the market because there have been reports of particulates in some vials. No problems have been found in any of the three countries--Germany, France and Spain--which most recently pulled drugs, but health officials there said it was a necessary precaution.  

Health officials in Germany banned Begripal and Fluad on Thursday, The Associated Press reports. They said Novartis was recalling them. In France, all doses of Agrippal are being removed from the market until the European Medicines Agency (EMA) says what it believes should be done. It is the only one of the suspected vaccines marketed there. Spain will halt the sale of all the Chiromas and Chiroflu vaccines, the Chicago Tribune reports.

The actions follow decisions to withdraw the drugs this week by health officials in Italy, where the vaccine was produced, and Switzerland, the homeland of Novartis. The U.K. is studying the situation but said so far there was no reason to take action, the Associated Press reports.

In a statement to FiercePharma, Novartis 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." Italian Health Minister Renato Balduzzi, however, said he wanted an answer from the company on why it didn't warn about the particle buildup before now, since it apparently noted the issue July 11.

The vaccines involved in the controversy are Agrippal, Fluad, subunit Influpozzi and adjuvanted Influpozzi. The situation complicates the flu vaccination schedules in Europe after Dutch vaccine maker Crucell withheld all of its vaccine because of quality questions.

In a statement emailed to FiercePharma, the unit of Johnson & Johnson ($JNJ) 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 that customers seek other sources, something Italy has said it is doing.

- here's the Reuters article
- get more from the Chicago Tribune
- read the AP story

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