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Novartis vaccines: block removed. The analyzes document the quality

Siena, 5 November 2012 – AFTER AIFA, the regulatory bodies of Canada and Switzerland are also about to decide to lift the blockade of flu vaccines Novartis. Health Canada (the country's public health agency) has completed its review of safety information on Agriflu (Agrippal) and Fluad vaccines and is in the process of releasing the two vaccines for immediate use, while Switzerland lifted the blockade.

As a precaution, the two products had in fact been temporarily withdrawn from distribution in Canada last week pending the institution's investigations. Health Canada has conducted tests, assessed health risks, reviewed information from European partners and data provided by Novartis, and none of this information has identified a safety concern. The Canadian agency is now advising healthcare professionals that they can start using these vaccines again, following the prescribed directions on their use and storage. Adverse events will be monitored for early detection of potential safety issues. No adverse reactions have been reported to date.

In Switzerland Swissmedic (the medicines agency) has lifted the interruption of supply and use of flu vaccines by Novartis, which has documented the quality of the consignments supplied in Switzerland and those yet to be supplied. On 24 October 2012, Swissmedic had ordered the interruption of the supply and use of the Agrippal and Fluad vaccines, following reports from Italy of possible impurities in vaccines originating from Italy and destined for Switzerland. The documents sent to Swissmedic by Novartis prove that the partially visible white particles are not external impurities, but aggregates of normal protein components of the vaccine, which can form during the manufacture of the vaccine and which then dissolve with the correct application of the injection. Swissmedic's analyzes confirmed the quality. All specialists will have to report any undesirable effects.

5 November 2012 – The Siena Nation

Vaccines, decreasing trust

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco