The Paul Ehrlich Institute in Langen decides whether a corona vaccine goes on clinical trial and whether it is subsequently approved.

Director Klaus Cichutek explains where things are heading.

Professor Cichutek, how would you describe the role of the Paul Ehrlich Institute during the corona crisis?

Professor Klaus Cichutek: The Paul Ehrlich Institute is the German Federal Institute for Vaccines and Biomedicines. We actively contribute to combatting the worldwide corona pandemic. In the case of vaccines, we focus on making sure vaccine products are safe and sufficiently effective. To this end, we are busy intensively advising national and international vaccine developers on the clinical trials, the necessary non-clinical tests, and also the development path through to approval. We authorize the clinical trials in Germany for vaccines and biomedicines, and together with the experts from the other national medicine approval authorities in Europe at the European Medicines Agency we evaluate the applications for approval as soon as these are received. Approval itself is granted by the European Commission.

The development of a vaccine seems to be very time-intensive and complex. Why is that so?

Professor Klaus Cichutek: Vaccines are administered to millions of primarily healthy persons, among them children and young people, for the purposes of preventing an illness. The benefits of the vaccines must therefore clearly outweigh the risks. This is the reason why, prior to approval of a clinical trial, there must be proof that the quality of the production of the vaccine is assured, that extensive non-clinical studies have been carried out on the vaccine’s safety and to demonstrate it triggers a specific immune response, and that during the clinical trials its safety as a medicine and effectiveness will be shown. Thus, at least 3,000 persons must take part in the Phase 3 trials, preferably more, in order to determine the side effects of 1 to 1,000 vaccinations or more with due certainty.

In April, you authorized the clinical trial of a potential Covid vaccine made by Mainz-based biotechnology company BioNTech. It involves so-called RNA vaccines. What is special about them?

Professor Klaus Cichutek: BioNTech was the first applicant in Germany and at that point in time the third or fourth worldwide. The special thing about RNA vaccines is that they can be developed far more swiftly than the established inactive vaccines. There is no need for the complex culture of the virus, such as is required, for example, for influenza vaccines, which is something that has to take place under next-level safety conditions. According to the manufacturer, within the short space of a few weeks many millions of vaccine doses can be produced. Even if, to date, there are no RNA-based human vaccines that have been approved, there is already data from clinical trials with RNA tumor vaccines.

The region seems to be well supported in the corona crisis, what with the BioNTech corporation in Mainz, the pharmaceutical corporation Sanofi in Frankfurt and, not least, the Paul Ehrlich Institute in Langen. Do you share my view?

Professor Klaus Cichutek: Yes, I have the same impression. Sanofi is a front-line international player, BioNTech wants to get there, too. We should also mention the outstanding virologists at the major universities in the region, namely in Frankfurt/Main, Giessen, Mainz and Marburg, not forgetting the City of Frankfurt Dept. of Health, which is also responsible for the airport and plays an important role in combating Covid-19. And we at the Paul Ehrlich Institute discharge duties far beyond the region, too.

How does the Paul Ehrlich Institute compare to its international peers? And how well is it networked, for example with the WHO?

Professor Klaus Cichutek: Every country has a medicines agency. What is unique about the Paul Ehrlich Institute is that we specialize in vaccines and biomedicines as well as in antibodies and medicines for hematology and transfusion medicine and that, as a medicines agency, we also conduct research. With our research efforts, we help everyone to know more about medicines and how they function, and that improves the development of medicines and their evaluation. Moreover, we are among the most active members in the Europeannetwork of official medicines control laboratories (OMCL), which are responsible throughout the EU for testing experimental medicine batches. In Germany, no vaccine may go to market until the batches have been officially released for use. To this end, samples of every vaccine batch are experimentally tested before they are marketed and used, be it by the Paul Ehrlich Institute or another OMCL. We are recognized by the WHO, the group of European and globally active medicines agencies, the European Medicines Agency, the European Directorate for the Quality of Medicines & HealthCare, and other organizations and committees as an active and expert partner.

In your opinion, how are things likely to continue? When might a vaccine be approved and when would it then be available in larger quantities?

Professor Klaus Cichutek: BioNTech has announced that it will be filing an application for approval this autumn, presumably with the European Medicines Agency. Assuming the data submitted suffices, vaccine products could be approved worldwide by the end of this year or the beginning of next year. At the moment, the Paul Ehrlich Institute, the Robert Koch Institute, the federal states and the Federal Ministry of Health are elaborating a concept for how vaccine supplies will be maintained and how the vaccination process will unfold.

Do you discern any opportunities to improve or accelerate the development of a vaccine? Corona is not likely to be the last virus that threatens us.

Professor Klaus Cichutek: The regulatory process has already been accelerated and optimized. At a very early date we provided scientific advice for the vaccine developers. We put in place a procedure that allows initial data packages to be submitted to us for pre-evaluation as soon as they are ready – instead of after the application is filed. And thirdly, phases in the clinical trials that otherwise have to be completed sequentially can be combined. We need to learn for the future, to use the experience gained, to be able to adjust faster to new possibly epidemic or pandemic pathogens that are new to humans or recur in us. The Paul Ehrlich Institute can make an important contribution to future efforts to combat pandemics by means of vaccines and biomedicines, too.

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