No BSE risk in vaccines!

"According to state-of-the-art knowledge on vaccines, the latter do not bear any BSE risk and the risk of a BSE transmission by vaccines is highly hypothetical," says Prof. Johannes Löwer, President of the Paul-Ehrlich-Institut in Langen (near Frankfurt). On the other hand, vaccines can protect effectively and safely from infectious diseases such as hepatitis and tetanus, which still present very realistic health hazards even today.

Reports in the New York Times in early February 2001 stating that BSE contaminated vaccines might circulate on the US market, also created a feeling of uncertainty in patients in Germany. The reports argued that cow products from non-BSE free countries had been used for vaccine production. "News agency reports stating that there are vaccines, which contain cow cells, are absolutely wrong, not to say irresponsible," Löwer comments the reports spread in Germany.

"Serum from young calves or meat extract from muscle flesh rank among those substances needed for the vaccine production," Löwer explains. Both are used for the cultivation of pathogens, which the vaccines are made from, but are washed out afterwards. They are not contained in the finished vaccine. The only exception is the lactose, which is made from milk. It is contained in the HIB (Haemophilus influenza, type B) vaccine as a stabiliser. Serum, as well as milk or muscle flesh belong to risk category IV (= no infectiousness detectable).

Background information:

In a report dated 8th February 8 2001, the New York Times criticised that cow materials from non-BSE free countries had been used for the production of nine vaccines, which had been granted a marketing authorisation in the USA. It is from this fact that the New York Times deduces a possible BSE risk. Germany also belongs to these non-BSE free countries, and muscle flesh, which is used as meat extract for the cultivation of bacteria, or serum from very young or unborn calves, which is needed for the cultivation of cells, in which vaccine viruses are multiplied, belong to the materials used.

In order to achieve highest possible transparency, the FDA (Food and Drug Administration), which is the US Federal Agency for Health, had published some information concerning vaccines, for the production of which cow materials or cow products from European cows are used, on their web-site on 22nd December 2000. However, the FDA also pointed out that a BSE risk could hardly be expected from these vaccines, and gave a maximum probability of 1:40,000,000. At the same time the FDA had made a link on their website to an article published in the specialist medical publication MMWR (Morbidity and Mortality Weekly Report), which describes the findings and recommendations of an inter-disciplinary conference from July 27, 2000, where specialists and vaccine experts discussed the topic of TSE (Transmissible spongiform Encephalopathy).

According to the experts' opinions the risk that vaccines transmit or spread the variant of the Creutzfeldt Jakob Disease (vCJD) can be ruled out. Furthermore, the experts stated that the benefits of vaccinations by far outweigh the hypothetical risk to fall ill with vCJD. Vaccination programmes, which would be interrupted or not carried out for fear of BSE and vCJD would certainly cause damage beyond repair.

European authorities and organisation, too, which deal with the marketing authorisation procedure of vaccines, have carried out a detailed evaluation of all vaccines, for the production of which cow materials or cow products are used. The Paul-Ehrlich-Institut has been one of the organisations responsible for this evaluation. At a European level, too, the conclusion that there is no risk of a transmission of TSE by vaccines is unanimous.

The manufacturers of vaccines are legally obliged to give proof that the cow materials or cow products used for the vaccine production satisfy the strict guidelines and decrees. The Paul-Ehrlich-Institut very strictly monitors the adherence to these regulations.

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