Switzerland flu vaccines released again

Application stop lifted for Novartis flu vaccine

01.11.2012

In recent weeks, threatening bottlenecks in the supply of flu vaccines in individual states were public. The sale of two influenza vaccines from the Swiss pharmaceutical company Novartis, imposed by the Paul Ehrlich Institute (PEI), further exacerbated the situation. In Switzerland, too, the competent authority Swissmedic ordered on 24 October a precautionary application ban for the flu vaccines Agrippal and Fluad.

The reason for the ban on the use of influenza vaccines was flocculation discovered in syringes from a Novartis factory in Italy. The identifiable flocculations could potentially pose a health risk, forcing the competent authorities in Italy, Germany, Austria, Spain, Canada and Switzerland to intervene. In Switzerland and Canada, however, Novartis' flu vaccines have now been released. The pharmaceutical company was able to document the quality of the contested vaccine batches, so that the delivery and application stop was lifted, explains Swissmedic in a recent press release.

No external contamination of the flu vaccine
First, it was suspected that the flocculations indicate a potentially harmful contamination of the flu vaccines. However, the documents submitted to Swissmedic by Novartis show that the „partially visible white particles“ none in the vaccine syringes „External contaminants, but aggregates (small clumps) of normal protein components of the vaccine“ are, reports the Swiss authority. The flocculation may occur during vaccine production, but, according to the experts, it dissolves when the syringe is used correctly (gentle shaking before injection).

Flu vaccine released immediately
Thus, the effectiveness and safety of the flu vaccine is not affected by the occasional aggregates, according to the Swiss Authorization and Control Authority for Remedies Swissmedic. The analysis of samples in the laboratory also confirmed the quality of the vaccines. Patients therefore do not have to fear extraordinary health problems due to the use of flu vaccines beyond the known potential side effects. In Switzerland, the vaccines can „be used again immediately“, This is the message from Swissmedic. Nevertheless, the experts are still encouraged to do so, „to observe the instructions and specifications in the technical information“ and „adverse drug reactions“ to report to the authorities. (Fp)

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