The President of the Paul-Ehrlich-Institut, Professor Klaus Cichutek, and the Vice President of the Paul-Ehrlich-Institut, Professor Stefan Vieths, take stock.
Klaus Cichutek: "We experienced the pandemic as a very challenging and demanding time. From my point of view, however, we were also able to demonstrate our capabilities and show that we can cope with a high volume of regulatory, research, and communications tasks. I am very proud of our employees. Through their commitment and, of course, through measures for accelerated authorisation and approval procedures as well as the many interactions with vaccine developers that were requested of them, the newly developed COVID-19 vaccine products were quickly authorised and made available. We will continue to benefit from these experiences in the future. The SARS-CoV-2 pandemic has also given us many new insights into mRNA and adenovector vaccines. One aspect that certainly speaks for mRNA vaccines is the rapid production of millions of vaccine doses and the short-term ability to adapt to new virus variants. SARS-CoV-2 is constantly evolving. In order to trigger a better immune response and to continue to be protected against severe COVID-19, it is therefore important to adapt the authorised vaccines to the circulating variants - as we have already done with the COVID-19 vaccine products adapted to the different Omicron variants. In general, after several billion COVID-19 vaccinations worldwide, we can say that serious side effects have occurred only rarely and that the authorised COVID-19 vaccine products continue to have a positive benefit-risk ratio. With the establishment of the Center for Pandemic Vaccines and Therapeutics (ZEPAI) at the Paul-Ehrlich-Institut in October 2021, we already began to take on important tasks in distribution during the pandemic and prepare for possible future pandemics. ZEPAI has concluded pandemic preparedness contracts with pharmaceutical companies on behalf of the Federal Republic of Germany. The Federal Republic of Germany has thereby ensured a rapid and sufficient supply of vaccines to the German population in the event of a pandemic."
Klaus Cichutek: "Our website has always served to offer all our stakeholders centralised and up-to-date information with verified facts. During the pandemic, we established ourselves as a reliable source of valid information. One way we do this is by supporting journalists in clarifying misinformation. We also answer questions and clarify errors directly with inquirers from the general public. Especially in times like these when fake news spreads very easily and quickly, it is extra important to us to provide the public with scientifically sound and trustworthy information."
Stefan Vieths: "The Paul-Ehrlich-Institut worked closely with the Federal Police, especially at the beginning of the vaccination campaign, to identify forged vaccination certificates. Since mid-2021, our administrative duties have included sending the Federal Police the names of valid batches of authorised vaccines for vaccination certificate checks. Together with ABDA, the Federal Union of German Associations of Pharmacists, we have also developed software that allows pharmacists to directly query a vaccine batch number online in order to check vaccination certificates."
Stefan Vieths: "We learned a lot about remote work and online meetings, especially at the beginning of the COVID-19 pandemic. Today we seamlessly combine remote work opportunities with on-site work in teams. Many business trips are now also being substituted by participation in online meetings, which saves time and resources and promotes sustainability. The Paul-Ehrlich-Institut is currently in the midst of a comprehensive reorganisation process that will allow it to continue to be well-positioned and to cope with future tasks. One of the goals of the reorganisation is to create uniformity between the divisions in terms of structure and process and to enable more flexibility and efficiency at the same level of effectiveness or higher. Division heads will also take on more regulatory responsibilities in the future. At the same time, we will continue to orient our divisions by product and to follow the proven concept of combining research and regulation. Most divisions have already been restructured. The restructuring was and is associated with great efforts for the employees and requires a high degree of adaptability and willingness to change. We are very grateful that the employees are actively involved in the reorganisation and that we are positioning ourselves for the future together through the Paul-Ehrlich-Institut's new organisational structure."
Klaus Cichutek: "This trend will continue. In the field of monoclonal antibodies, immunotherapy of oncological diseases, cell therapeutics, and gene therapeutics, we support many developments for both rare and common conditions - from scientific advice and the approval of clinical trials to marketing authorisation and then life cycle management and pharmacovigilance. The Institute's own research ensures the comprehensive technical expertise required for the reliable evaluation of complex biomedicines. In all divisions dealing with the quality, efficacy and safety of medicines, research and regulatory activities are directly linked. AI-based methods will play an important role in the future for the efficient evaluation and regulation of biomedicines. We are already investigating how new methods, particularly in the field of artificial intelligence, can be used in a meaningful way. Supporting the development of medicinal product innovations for the benefit of people and vaccinees is part of the Paul-Ehrlich-Institut's current DNA."