05 / 2023
Federal Minister of Health Professor Karl Lauterbach visited the Paul-Ehrlich-Institut (PEI) on 6 June, 2023, and recognised the outstanding role that the Federal Institute for Vaccines and Biomedicines played during the pandemic in the regulation of vaccine development, batch testing and marketing authorisation. The Paul-Ehrlich-Institut supported the development and marketing authorisation processes of the COVID-19 vaccines with numerous intensive scientific advice sessions and flexible procedures. Furthermore, the Paul-Ehrlich-Institut supported the development of antibody therapeutics for the treatment of high-risk COVID-19 patients and carried out a comparative evaluation of the sensitivity of SARS-CoV-2 rapid antigen tests. With an eye to optimal preparation for future pandemics, ZEPAI – Center for Pandemic Vaccines and Therapeutics – was founded at the Paul-Ehrlich-Institut while the COVID-19 pandemic was still ongoing. The Institute's specialisation in biomedicines and its combination of drug evaluation, testing and research activities are an important advantage for Germany and Europe with regard to the production and development of innovative vaccines and biomedicines for the benefit of vaccinees and patients.
Professor Karl Lauterbach in conversation with Professor Klaus Cichutek (Source: Morgenroth / Paul-Ehrlich-Institut)
Federal Minister of Health Professor Karl Lauterbach:
“The Paul-Ehrlich-Institut played a major role in Germany's emergence from the pandemic in relatively good shape. The Institute was involved in the marketing authorisation and testing of the vaccines. Its work was internationally recognised and had great influence. It was the point of contact for reports of vaccine complications and a reliable resource for scientifically sound information. Fake news is best fought with objectivity and seriousness. The Paul-Ehrlich-Institut stands for both. We are particularly indebted to the head of the Paul-Ehrlich-Institut, Professor Cichutek.”
Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut:
“Today we are very pleased to welcome Professor Karl Lauterbach, Federal Minister of Health, to the Paul-Ehrlich-Institut and to present our wide range of national and international activities in the fields of medicinal product regulation, testing, and research. For the Paul-Ehrlich-Institut, the visit of the Federal Minister is a recognition of our experts' scientific achievements, especially during the pandemic. The specialisation and competence of the Paul-Ehrlich-Institut and its international networking with WHO and other globally recognised medicines authorities offer added value to Germany and Europe with regard to developments in innovative medicinal products.”
The Federal Ministry of Health and the Paul-Ehrlich-Institut also worked closely together during the pandemic to enable the rapid development and availability of safe and effective vaccines and antibody therapeutics against COVID-19 for Germany and Europe. A comparative evaluation of the sensitivity of SARS-CoV-2 rapid antigen tests helped to achieve the best possible detection of infections. These actions helped to protect many members of the public from infections and serious illnesses and to maintain a functioning healthcare system.
Even in non-pandemic times, the Paul-Ehrlich-Institut makes significant contributions to the development of innovative medicinal products. The Paul-Ehrlich-Institut's specialisation in vaccines and highly complex biomedicines, its combination of research, experimental medicinal product testing and regulation, the designated WHO Collaborating Centres at the Institute, and its global network are invaluable strengths that are used to effectively support medicinal product development.
The Federal Minister of Health received information from the staff entrusted with medicinal product testing about the batch testing of COVID-19 vaccines at the Paul-Ehrlich-Institut for Germany and Europe. Batch testing – the final regulatory test of the quality of the COVID-19 vaccines – and national batch release ensure a high level of quality for the vaccines that are administered. The new testing methods that were needed for the COVID-19 vaccines were established at the Paul-Ehrlich-Institut in the shortest possible time. This allowed the first batches of the first newly authorised mRNA COVID-19 vaccine to be released on 22 December, 2020 – just one day after the conditional marketing authorisation of the vaccine product by the EU Commission, which preceded the medicinal product evaluation in bodies of the European Medicines Agency with the participation of the Paul-Ehrlich-Institut.
During his visit, the Federal Minister received information about the current state of research at the Institute. Research at the Institute is financed by extra project funds from the Federal Ministry of Health (Bundesgesundheitsministerium, BMG) and other public third-party funding agencies. Laboratory tests on mice that succeeded in producing tumour-fighting immune cells, known as CAR-T cells, directly in the body attracted particular interest. CAR-T cells authorised as human medicines allow an effective therapy of leukaemia and lymphoma in patients for whom all treatment options have been exhausted, so great hope is placed in continuing their development for the therapy of solid tumours. Using imaging techniques, the Paul-Ehrlich-Institut analyses the structure and antibody binding to the spike protein of SARS-CoV-2 in order to better understand the mechanism of virus neutralisation by antibodies.
The Paul-Ehrlich-Institut combines research and medicines regulation and thus offers great expertise in the evaluation of new vaccines and biomedicines. Laboratory research enables the Paul-Ehrlich-Institut to learn about new manufacturing and testing methods as well as safety aspects at an early stage in order to be able to make informed decisions regarding applications for approval of clinical trials, evaluations of medicinal products for marketing authorisation, and pharmacovigilance. Pharmacoepidemiological research complements the Institute's pharmacovigilance activities, i.e. the observation of medicinal product side effects and the adoption of appropriate risk reduction measures. Due to progressive digitalisation and the testing of AI applications, medicines regulation at the Paul-Ehrlich-Institut is continuously being developed.
The Federal Minister took the opportunity to meet in person with Institute employees as well as the staff representatives and committees. He praised the achievements of the Paul-Ehrlich-Institut staff not only during the pandemic, but also with regard to all other diverse activities in the regulation of biomedicines.
ZEPAI – Center for Pandemic Vaccines and Therapeutics – already began to take on important tasks during the COVID-19 pandemic by managing the BMG's pandemic preparedness contracts with the vaccine manufacturers as well as managing the storage and distribution of the pandemic vaccines in order to prepare demand-based pandemic vaccine stocks for the future.
Building on the experience with mRNA and vector vaccines in the pandemic, new therapeutic developments based on mRNA and vectors are expected in the near future also within the other highly complex medicinal product groups in the field of biomedicine. A supportive and, at the same time, regulatory competent and strict medicines authority such as the Paul-Ehrlich-Institut makes an important contribution to Germany and Europe.
Updated: 06.06.2023
