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White particles: flu vaccine recalled

White particles: flu vaccine recalled

Germany, Italy, Austria and Switzerland have recalled contaminated flu vaccines

Bottleneck for flu vaccine: The flu vaccine is becoming scarce in Bavaria, Schleswig Holstein and Hamburg. After the pharmaceutical manufacturer Novartis had already made negative headlines due to supply problems with the flu vaccine BEGREPAL, the Paul Ehrlicher Institute (PEI) is now announcing the freeze on the sale of two flu vaccines, since contaminations of BEGIPAL and FLUAD have been found in certain batches. These could trigger severe allergic reactions in the first few hours after vaccination.
Contaminated flu vaccine recalled The Paul Ehrlicher Institute (PEI), which is responsible for the release on the German market, has "as a precautionary measure" four batches of the flu vaccine BEGRIPAL with the batch numbers 126201, 126102A, 126101, 126202A, and one batch of the flu vaccine with batch number 128902. The Italian authorities had already stopped selling and using the vaccine on Wednesday, as white flocculation of the flu vaccine was noticed in some syringes. The Italian Ministry of Health, together with the Aifa pharmaceutical authorities, stated that the flu vaccine affected would have "potentially health-threatening quality defects". It was a precaution to avoid "unwanted reactions". According to the communication, however, no complaints have so far become known.

As the PEI reports, the white flocculation was not observed in Germany. Nevertheless, the institute decided to withdraw the approval for the batches, in the pre-production stages of which such changes were found. Vaccination with the contaminated vaccine could cause “allergic to anaphylactic reactions” in the first few hours afterwards, which can lead to life-threatening circulatory and organ failure. "Later reactions or late consequences have not yet been described," said the PEI. Accordingly, people who have already been vaccinated with Fluad or Gründipal need not fear late side effects.

"The Paul Ehrlich Institute has not received any side effects reports of severe intolerance reactions in the current season. In terms of risk prevention and consumer safety, however, it is necessary to withdraw the approval for certain batches of vaccine, since flocculation in the vaccine and thus serious side effects cannot be ruled out, "said Professor Klaus Cichutek, President of the PEI.

Cause of flocculation in the flu vaccine may be solvent Some experts, including Hildebert Wagner from the Center for Pharmaceutical Research at LMU Munich, suspect that the white flocculation is due to contamination. Since the virus that is used in the vaccines is reproduced in chicken eggs, it could also be protein. The white particles are not a direct flocculation of the vaccine but of the solvent, according to the experts. So far, however, no clear insights have been gained. However, it is certain that such flocculations do not normally occur in the flu vaccine.

With the withdrawal of the already scarce vaccine due to Novartis' delivery difficulties, the situation is now getting worse, especially in Bavaria, Schleswig Holstein and Hamburg.

The background is a tender that Novartis had won. The health insurance companies then concluded exclusive contracts with the pharmaceutical company for the low-cost vaccine, the BEGIPAL. At the beginning of October, however, Novartis announced that it would not be able to deliver the vaccine for the time being. The health insurers then released other vaccines for the affected regions. However, manufacturers of other agents such as Fluenz, the flu vaccines Stada and Ratiopharm, Inflexal V, Influvac, Intanza, and Mutagrip were not ready for the great demand after Novartis won the tender, so these companies too currently have insufficient vaccine stocks. The subsequent production of the flu vaccine is also excluded for the coming flu season, since the production of a vaccine requires a longer lead time. The preparation of the serums is very labor intensive and time consuming. It takes about six months to get the finished vaccine.

Other countries recall flu vaccine In addition to Italy and Germany, Austria and Switzerland have also recalled the flu vaccine, which was launched on the market in different countries. A total of several million vaccine doses are affected, which will not be available in the coming flu season. As reported by "Spiegel Online", every second one goes away empty-handed.

Novartis itself had informed the responsible authorities in Italy and Austria of the possible contamination. An expert opinion, which the manufacturer had commissioned, attests, however, that the flocculations are "harmless". According to Sigrid Rosenberger, spokeswoman for the Austrian Ministry of Health, the authority wants to check the vaccine itself. That could "take up to three weeks".

The Swiss approval and control authority for medicinal products "Swissmedic" also decided to stop selling the flu vaccine. According to a message, this is a pure precautionary measure that affects a maximum of 160,000 vaccine doses. People who have already been vaccinated in Switzerland are not in any health risk.

At a press conference to present the Novartis quarterly figures in Basel last Thursday, CEO Joseph Jimenez spoke about the vaccines and emphasized the safety and effectiveness of the serums. The funds were delivered to various European and Asian countries. The affected vaccine batches had already been sorted out after production in Italy and did not even come on the market there. This is evidence of the functioning quality assurance of Novartis. (ag)

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Image: Thomas Siepmann / pixelio.de

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