New Vaccine Information on the PEI Website

Since Monday, 7 May 2007, the Paul-Ehrlich-Institut has been providing a database with detailed information on suspected cases of adverse reactions following vaccination. The database is available on the PEI website at www.pei.de/db-verdachtsfaelle. The database allows a targeted search for particular reactions or vaccines. Professor Johannes Löwer, the President of the Paul-Ehrlich-Institut, emphasises: “We are the first medicines agency in Europe to make these data on suspected cases of adverse reactions following vaccination freely available in this form. With this step, we wish to contribute to improving and facilitating access to information on vaccinations by providing maximum transparency on adverse reactions following vaccination”.

For a better understanding of the database, it is important to know that it does not list confirmed cases of adverse reactions but suspected cases which have to be evaluated individually. Summary evaluations of the reports since 2001 have been published by the Paul-Ehrlich-Institut in the German language health journal “Bundesgesundheitsblatt”. These publications are also available on the PEI website at www.pei.de/impf-publikationen. What is new now is that the cases reported in these publications can be viewed in the database. “We have placed an explanatory text before giving access to the database. This text describes how to use the database and how reports of suspected cases are evaluated. The text also shows that the statistical validity of the data presented is too limited to permit any conclusions on the frequency of suspected cases”, explains Prof. Löwer. Reading this text is mandatory before accessing the database.

Reading the text is all the more important, since in the last few years, growing concern over real or alleged risks in connection with vaccinations can be observed in many countries, including Germany.. “Nowadays, the majority of infections which were common and feared in the past are encountered only by a small number of people. Very rare or even hypothetical adverse events therefore become a matter of public interest time and again”, says Prof. Löwer. The result is decreasing acceptance of vaccinations which leads to decreasing vaccination rates. This might cause a new increase in diseases which might otherwise have been prevented by vaccination. “This has promoted us to provide the freely searchable data accompanied by a comprehensive explanatory text”, explains Prof. Löwer.

For the time being, the database will include data from reports submitted since January 2001, when the German Infektionsschutzgesetz (Infection Protection Act) came into force. The database includes reports on suspected cases of harm to general health which goes beyond the usual vaccine reaction (suspected vaccine complications, Section 11, IfSG [German vaccination protection act]), and data on serious adverse reactions which have been reported to the Paul-Ehrlich-Institut pursuant to Section 63b Arzneimittelgesetz (AMG, German Medicinal Products Act) by the marketing authorisation holder or the respective pharmaceutical company in Germany. The Paul-Ehrlich-Institut also plans to include earlier data going back to 1992. For the time being, the database will be updated at half-yearly intervals.

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