Reuters: Regulatory News: UPDATE 1-Canada, Switzerland lift ban on Novartis flu vaccines

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UPDATE 1-Canada, Switzerland lift ban on Novartis flu vaccines Oct 31st 2012, 16:07 Wed Oct 31, 2012 12:07pm EDT * Swiss, Canadian health authorities to resume deliveries * Say own tests, Novartis data show flu vaccines safe * Italy still evaluating vaccines ZURICH, Oct 31 (Reuters) - Canadian and Swiss health authorities lifted a ban on Novartis's flu vaccines on Wednesday after the drugmaker showed they posed no risk to safety. Italy last week banned the sale of four anti-influenza vaccines produced by Novartis pending tests for possible side effects after small particles were found in some of the injections. Other countries including Switzerland, Austria, Germany, Spain and France followed suit by suspending deliveries, recommending the use of alternative products or recalling batches of the vaccines. Swissmedic and Health Canada said information from Novartis and their own testing had shown that white particles found in the vaccines were normal clumps of protein particles and did not indicate a safety issue. "According to the scientific data presented to us, the safety of the vaccines is not compromised by the stray aggregates," Swissmedic said in a statement. Novartis' Chief Executive Joseph Jimenez said last week he was confident the vaccines were safe after the company reported third-quarter sales that missed forecasts. The drugmaker said on Wednesday it was pleased with the Canadian and Swiss decisions and was working with other national health authorities to address concerns and resume deliveries. Italy's drug safety authority said it was still reviewing the results of tests on Novartis's anti-influenza vaccines, but is "cautiously positive" about being able to lift a ban on some lots in coming days. Novartis's vaccines Fluad and Agrippal, which are manufactured at a production site in Italy, were banned in Switzerland and Canada. Italy has also withdrawn subunit Influpozzi and adjuvanted Influpozzi. Germany's vaccine agency said it had retracted approval of some lots of Novartis's vaccines Begripal and Fluad, meaning those particular lots could not be released onto the market. Austria's health ministry said it is maintaining for now its advice for physicians to avoid using Novartis's Fluad and Sandovac in favour of other products. Link this Share this Digg this Email Reprints

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