Strong in the Pandemic
The Paul-Ehrlich-Institut has made a significant contribution to combating the SARS-CoV-2 pandemic. The prerequisite for this was maintaining its ability to function.
SARS-CoV-2 pandemic: what did it mean for the Paul-Ehrlich-Institut?
Professor Cichutek: The pandemic necessitated the rapid development and marketing authorisation of vaccines and biomedicines against COVID-19. We used our tried and tested processes, but were always open to new approaches. The broad-based positioning of the Paul-Ehrlich-Institut proved to be an advantage: as a major European player, we are involved in global networks, well-versed in regulatory issues and at the cutting edge of scientific knowledge.
Professor Vieths: We immediately took measures to maintain the Paul-Ehrlich-Institut's ability to function. In February 2020, we activated the internal crisis team, which monitored the pandemic situation and assessed its effects on internal processes. With a high level of specialist competence, the interdisciplinary team took balanced and practical decisions and thus created the working conditions in which the Paul-Ehrlich-Institut was able to make a full contribution to combating the pandemic.
Development and marketing authorisation of COVID-19 vaccines: how was it possible so quickly?
Cichutek: Previous work had been carried out on vaccines against SARS-CoV-1 and MERS, so the potentially protective antigen was already known. In addition, at the Paul-Ehrlich-Institut we already had experience in the development of mRNA and vector vaccines for other indications such as cancer and Ebola. This expertise enabled us to provide maximum support for the development of COVID-19 vaccines by means of scientific advice. Marketing authorisation was accelerated by combining clinical trial phases and by the use of “rolling reviews”. The safety and efficacy of the vaccines was the key factor at all times.
In-demand point of contact for the media: what is your message?
Cichutek: We provided the media and the general public with timely and scientifically based information on the latest developments in vaccines and biomedicines for use against COVID-19. In this way, we were able to convince many people to trust in the regulatory work of the Paul-Ehrlich-Institut and the European Medicines Agency – and thus possibly also contribute to a greater willingness among the public to be vaccinated.
Safety of COVID-19 vaccines: how is it monitored?
Cichutek: We have an established and effective pharmacovigilance system for monitoring the safety of vaccines and biomedicines – before and after marketing authorisation. At an early stage, we established additional measures, such as the SafeVac app, for monitoring the adverse effects of COVID-19 vaccines. Vaccinated people can use this tool to provide regular information on their state of health. This allows us to collect additional data on tolerability in good time – and in the long term also on efficacy.
European Medicines Agency (EMA): what is the cooperation like?
Cichutek: We collaborate intensively with experts from the other European medicines agencies in the EMA’s scientific committees and working parties – and are therefore an integral part of the EMA’s scientific work. In this regard, the Paul-Ehrlich-Institut makes an outstanding contribution: we have played the leading role in procedures for vaccines and biomedicines for over a decade. The European principle of making medicinal products available throughout Europe with a single central marketing authorisation from the European Commission has proved its worth during the pandemic.
International networks: what was the Paul-Ehrlich-Institut's contribution?
Cichutek: The Paul-Ehrlich-Institut has assumed responsibility for playing its part in combating the pandemic worldwide. For this purpose, we work closely with WHO and other international organisations. For instance, I am an ex-officio member of the International Coalition of Medicines Regulatory Authorities – the ICMRA. At the first ICMRA meeting at the start of the SARS-CoV-2 pandemic, we gave a presentation and were thus able to contribute to the globally harmonised scientific advice on the development of COVID-19 vaccines. At WHO, I am a member of the COVID-19 working party of the Strategic Advisory Group of Experts on Immunization – SAGE – and the Expert Committee on Biological Standardization – ECBS.
German EU Council Presidency 2020: what is the result?
Cichutek: Germany’s Presidency of the European Council in the second half of 2020 was dominated by the pandemic. The EU is a major global player, but this crisis has shown that cooperation and ability to react must be strengthened within Europe. Another important issue is how to improve the general conditions in the EU to ensure that in the future vaccines can be developed and manufactured in Europe to a greater extent – and that Europe is even better prepared for future pandemics. We contributed to these political discussions.
Official duties: how was the Paul-Ehrlich-Institut able to ensure its ability to function?
Vieths: The essential tasks, such as marketing authorisation, pharmacovigilance and batch testing, had to continue without any disruption. Assessors were able to process marketing authorisations remotely, as we introduced comprehensive working from home at an early stage. But, in particular, the loss of batch testing in the laboratories would have had an immediate impact on the availability of biomedicines. For this reason, we set up a system of working in shifts. The testing teams had no contact with one another, so that even in the event of an infection operational teams would still have been available. The laboratory staff were reinforced by scientists and laboratory technicians from Research.
SARS-CoV-2 infections: how was the Paul-Ehrlich-Institut able to prevent in-house chains of infection?
Vieths: The central element of our infection protection plan was an extensive testing strategy. Since March 2020, the Internal Medical Service – IMD for short – has been performing COVID-19 tests in-house. If an infection is detected, we have contained or prevented any spread by extensive testing and by the immediate identification and isolation of anyone with whom the infected person had been in contact. In more than a year of the pandemic, only 25 people from the whole workforce fell ill with COVID-19. In none of those cases was the infection transmitted within the Paul-Ehrlich-Institut.
Batch testing of mRNA vaccines: how was it possible to set it up so quickly?
Vieths: In parallel to marketing authorisation, we established and validated test methods for an mRNA vaccine and a vector vaccine. In this connection, the combination of research and marketing authorisation expertise at the Paul-Ehrlich-Institut, which is almost unique in Europe, as well as its intensive integration within the network of European control laboratories, proved to be invaluable. The first batches of the COVID-19 vaccine had already been tested when the European Commission issued the marketing authorisation on 28 December 2020. The vaccinations could begin immediately.
IT infrastructure: what were the challenges?
Vieths: Working from home suddenly became the new normal. In just a few weeks the number of remote workers increased many times over, and virtual meetings became the standard. We had to create the necessary technical conditions for this in a short period of time and acquire the relevant office equipment. Members of staff can now access the systems irrespective of their location and can deal with processes digitally from start to finish.
Future visions: how is the Paul-Ehrlich-Institut positioned for the next few years?
Vieths: We will implement the measures of the organisational review that was completed in 2020 and access new resources by optimising structures and processes. The new building for the Paul-Ehrlich-Institut in Langen is also well underway. We will hold an architectural competition in 2021, which we anticipate will also be completed this year.
I am convinced that this package of infrastructural and organisational measures will enable us to secure the future of the Paul-Ehrlich-Institut as one of the leading medicinal product institutes in the field of vaccines and biomedicines.
Cichutek: During the pandemic, we were able to use our strengths, but also to gain valuable experience. Based on this knowledge, we will set up a pandemic centre for vaccines at the Paul-Ehrlich-Institut. In this connection, we will benefit from our unique combination of research and regulation, as well as product-specific specialisation – including in the regulation of all other, non-COVID vaccines and biomedicines.