White particles called the flu vaccine

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

26/10/2012

Bottleneck in influenza vaccine: In Bavaria, Schleswig Holstein and Hamburg, the flu vaccine is scarce. The pharmaceutical company Novartis has been negatively hit by headlines due to delivery problems with the influenza vaccine, the Paul-Ehrlicher-Instut (PEI) now announces the cessation of sales of two influenza vaccines, as impurities have been detected in certain batches of cyanide and fluad. These could trigger severe allergic reactions in the first hours after vaccination.
Polluted flu vaccine recalled
The Paul Ehrlich Institute (PEI), which is responsible for the release on the German market, has „as a measure of risk prevention“ recalled four batches of the influenza vaccine, Begipal with lot numbers 126201, 126102A, 126101, 126202A, and a lot of flu vaccine Fluad lot no. 128902. Already on Wednesday, the Italian authorities had ordered a stop of sales and use of the vaccine, as in some syringes white flocculation of the flu vaccine had been noticed. The Italian Ministry of Health, together with the Aifa Pharmaceutical Authority, said that the influenza vaccine affected „possibly health-threatening quality defects“ would be present. It is a precautionary measure „unwanted reactions“ to avoid. According to the announcement, however, no complaints have been published so far.

As the PEI reports, the white flocculations were not observed in Germany. Nonetheless, the Institute decided to withdraw the release for the batches that identified such changes in their pre-production stages. Inoculation with the contaminated vaccine could occur in the first few hours thereafter „allergic to anaphylactic reactions“ that can lead to life-threatening circulatory and organ failure. „Later reactions or late effects have not been described“, said in an averaging of the PEI. Thus, people who have already been vaccinated with Fluad or Begripal, do not fear any late side effects.

„The Paul-Ehrlich-Institut has not received any adverse reactions in the current season about severe intolerance reactions. However, in the interests of risk prevention and consumer safety, it is necessary to withdraw the release for certain vaccine batches, as flocculation in the vaccine and thus severe side effects can not 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 the LMU Munich, suspect that the white flocculations are due to impurities. Because the proliferation of the viruses used in the vaccines is done in chicken eggs, it could also be protein. The white particles are not direct flocculation of the vaccine but of the solvent, according to the experts. So far, however, no clear findings could be obtained. However, it is clear that such flocculations do not normally occur in the flu vaccine.

The withdrawal of the already scarce vaccine due to the delivery difficulties of Novartis now aggravates the situation, especially in Bavaria, Schleswig Holstein and Hamburg.

Background is a tender that Novartis had won. The funds closed then exclusive contracts for the cheap vaccine Begripal with the pharmaceutical company. In early October, however, Novartis announced that it would not be able to deliver the vaccine for the time being. As a result, the funds had also released other vaccines for the affected regions. Manufacturers of other medicines, such as Fluenz, the influenza vaccines Stada and Ratiopharm, Inflexal V, Influvac, Intanza, and Mutagrip, however, did not respond to high demand after Novartis won the tender, so these companies currently have too few vaccine supplies. The subsequent production of the flu vaccine is also excluded for the upcoming flu season, as the production of a vaccine requires a longer lead time. The preparation of the sera is very laborious 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 that was put on the market in countries with different names. Overall, several million vaccine doses are affected, which are not available in the upcoming flu season. As „Mirror online“ reported, every second empty.

Novartis had informed the relevant authorities in Italy and Austria about possible contamination. An opinion commissioned by the manufacturer, however, certifies the "safety of flocculation". As Sigrid Rosenberger, spokeswoman for the Austrian Ministry of Health, said, the agency wants to check the vaccine itself. That could take up to three weeks.

Also the Swiss approval and control authority for remedies „Swissmedic“ decided to stop selling the flu vaccine. According to a communication, this is a mere precautionary measure that affects a maximum of 160,000 vaccine doses. Persons who were already vaccinated in Switzerland were in no danger to health.

At a press conference on the presentation of the Novartis quarterly figures in Basel last Thursday, CEO Joseph Jimenez commented on 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 get into commerce there. This is proof of the functioning quality assurance of Novartis. (Ag)

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Image: Thomas Siepmann