Novartis flu vaccine application stopped
In recent weeks there have been looming bottlenecks in the supply of flu vaccines in individual federal states. The situation was further exacerbated by the sale of two flu vaccines by the Swiss pharmaceutical company Novartis imposed by the Paul Ehrlicher Institute (PEI). In Switzerland, the competent authority Swissmedic also ordered a preventive use stop for the flu vaccines Agrippal and Fluad on October 24th.
The cause of the stop of the flu vaccines was flocculation, which was discovered in vaccine syringes from a Novartis factory in Italy. The detectable flocculation could have represented a health risk, so that the responsible authorities in Italy, Germany, Austria, Spain, Canada and Switzerland were forced to intervene. However, Novartis flu vaccines have now been released in Switzerland and Canada. The pharmaceutical company was able to document the quality of the vaccine batches that were the subject of the complaint, so that the delivery and application freeze was lifted, Swissmedic explains in a current press release.
No external contamination of the flu vaccine At first, there was a suspicion that the flocculation indicated a potentially harmful contamination of the flu vaccine. However, the documents submitted to Swissmedic by Novartis show that the "partially visible white particles" in the vaccine syringes are not "external contaminants, but aggregates (small clumps) of normal protein components of the vaccine," reports the Swiss authority. The flocculation can arise during the manufacture of the vaccine, but according to the experts, it resolves when the syringe is used correctly (shaking gently before the injection).
Flu vaccine released again immediately According to the Swiss regulatory and control authority for medicinal products, Swissmedic, the effectiveness and safety of the flu vaccine will not be impaired by the occasional aggregates. The analysis of random samples in the laboratory also confirmed the quality of the vaccines. Patients do not have to fear any extraordinary health problems beyond the known possible side effects due to the use of the flu vaccines. In Switzerland, the vaccines can “be used again immediately,” according to Swissmedic. Nevertheless, the experts are still asked to "observe the information and guidelines in the specialist information" and to report "undesirable drug effects" to the authorities. (fp)
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