Paul Ehrlich Institute: How the authorities decide on vaccines

The AstraZeneca vaccine is no longer vaccinated in Germany for an indefinite period. Federal Health Minister Jens Spahn (CDU) pulled the emergency brake after seven cases of more than 1.6 million vaccinations were known, including three deaths in which cerebral vein thrombosis occurred in connection with the AstraZeneca vaccination. That’s roughly four cases per million people vaccinated.

Rethinking after “intensive consultations”

In it, the scientists write of “intensive consultations” that would have made them rethink. Because last week Germany wanted to keep vaccinating with AstraZeneca.

One letter is enough to shake the entire German vaccination campaign? The Paul Ehrlich Institute, which emerged from the “Institute for Serum Research and Serum Testing” founded in 1896, not only has a long history, but also the relevant authority as the “Federal Institute for Vaccines and Biomedical Medicines”. It is named after its first director, the German immunologist and Nobel Prize winner Paul Ehrlich (1854–1915).

The institute in Langen, Hesse, reports to the Ministry of Health and regulates vaccines and drugs. In this function, the in-house experts decide on the approval of vaccines and biomedical drugs. The approval of clinical studies on the drugs supervised by the institute also falls within the scope of duties.

“I think we have a special obligation here”

Accordingly, the vaccination break for AstraZeneca is defended by PEI President Klaus Cichutek. “Citizens want to be sure that the vaccines we allow are safe and effective,” Cichutek told the ARD “Tagesthemen”. “I think we have a special obligation here.”

The decision to suspend the AstraZeneca vaccinations was accordingly made unanimously by the institute’s experts. Everyone agreed that the seven cases observed “could be related to the vaccination”.

Strict quality standards apply in the institute. According to the company’s own statements, publications and expert reports from the company are subject to a four-eyes principle. Everything that is published is approved again by a member of the management team. There are currently five women and seven men, including PEI President Cichutek. Research in the fields of virology, immunology, allergology and hematology is internationally recognized, among others the World Health Organization (WHO) cooperates with the Paul Ehrlich Institute.

Power through batch release

As an independent higher federal authority, the institute is financed from tax money, but also externally funded – among others by the European Commission or the German Research Foundation (DFG).

In addition to the vaccine approval, the authority is also responsible for state batch release of the substances. This is precisely where a large part of their power lies. In Germany, a state inspection of vaccine batches is required by law before marketing. Even if pharmaceutical companies already have high quality standards – their vaccines have to go through the PEI laboratory again.

Editor’s note: In an earlier version of this article it was stated that the Paul Ehrlich Institute had only been called that since 1972; in fact, it was renamed as early as 1947. It is also incorrect that the PEI is responsible for medical technology. We have corrected the passages.

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